预约演示
更新于：2025-06-12
Sodium Oxybate
羟丁酸钠
更新于：2025-06-12
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2002-07-17), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (澳大利亚) |
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结构/序列
分子式C4H8NaO3 |
InChIKeyWFBCFGRDCIMEAM-UHFFFAOYSA-N |
CAS号502-85-2 |
关联
69
项与 羟丁酸钠 相关的临床试验NCT06950281
Low Sodium Oxybate Use for Nocturnal Cluster Headache: Safety, Efficacy and Tolerability of JZP-258 (XYWAV) - a Phase 2 Randomized, Double-Blind, Placebo-Controlled, Bi-center Study.
The goal of this clinical trial is to evaluate the efficacy of low sodium oxybate (LXB) (brand name Xywav) in the treatment of (nocturnal) cluster headache attacks in subjects with chronic cluster headache.
It is an 18 week, randomized, double-blind, placebo- controlled, bi-center trial.
LXB will be administered as a twice nightly regimen. All subjects will undergo an 8 week Treatment Titration and Optimization Phase.
The main trial endpoint is the change from baseline in average weekly frequency of nocturnal cluster headache attacks over 4-week fixed stable dose of treatment period.
It is an 18 week, randomized, double-blind, placebo- controlled, bi-center trial.
LXB will be administered as a twice nightly regimen. All subjects will undergo an 8 week Treatment Titration and Optimization Phase.
The main trial endpoint is the change from baseline in average weekly frequency of nocturnal cluster headache attacks over 4-week fixed stable dose of treatment period.
开始日期2025-12-01 |
申办/合作机构 |
NCT06809803
Safety, Convenience, and Tolerability of a Nightly Single Oral Dose of Extended-release Sodium Oxybate in Children
The main objectives of this study are to determine the treatment preferences of children with narcolepsy type 1 between Extended-release sodium oxybate and Non-extended-release oxybates (Sodium oxybate or a medication with the combination of Calcium, magnesium, potassium, and sodium oxybates). The study will also assess the safety, convenience, and tolerability of Extended-release sodium oxybate. Additionally, the researchers aim to assess how well Extended-release sodium oxybate works in treating narcolepsy type 1.
开始日期2025-02-01 |
申办/合作机构  Stanford University [+1] |
NCT06525077
A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia (IH)
This is a double-blind, placebo-controlled, randomized withdrawal, multicenter study of the efficacy and safety of FT218. FT218 drug product is a once-nightly formulation of sodium oxybate for extended-release oral suspension. The study will enroll subjects who are diagnosed with idiopathic hypersomnia. Subjects will be eligible to enroll regardless of current treatment with oxybate therapy or stimulants/alerting agents at study entry. The estimated total duration of study for each subject is approximately 18 weeks, including the Screening period.
开始日期2024-08-01 |
申办/合作机构 |
100 项与 羟丁酸钠 相关的临床结果
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100 项与 羟丁酸钠 相关的转化医学
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100 项与 羟丁酸钠 相关的专利（医药）
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5,350
项与 羟丁酸钠 相关的文献（医药）2025-12-01·Sleep medicine: X
Comparative efficacy of sodium oxybate versus placebo on improvement of nighttime sleep in adult patients with narcolepsy: A systematic review and meta-analysis
Review
作者: Zahoor, Hafiz Shahbaz ; Arshad, Adina ; Fatima, Anfal ; Nazakat, Ayesha ; Iqbal, Javed ; Masood, Muhammad Abdullah ; Qureshi, Muhammad Abdul Muqtadir
Background:
Narcolepsy, a central hypersomnolence disorder, disrupts sleep regulation. Sodium oxybate, a CNS (central nervous system) depressant, is widely used as a treatment, but there are surprisingly very few rigorous studies comparing its effectiveness to placebo in adults.
Objectives:
To measure the comparative efficacy of sodium oxybate at a dosage regimen of 9 g versus placebo in improving nighttime sleep quality, reducing nocturnal arousals and sleep stage shifts, and enhancing the overall refreshed nature of sleep in adult patients with narcolepsy.
Methods:
The methodology included a literature review of PubMed, Cochrane, Scopus, Google Scholar, and Clinicaltrials.gov, retrieving 53 randomized controlled trials (RCT) after removing 14 duplicates. Four studies met the criteria for gauging the efficacy of sodium oxybate compared to placebo in the adult population with narcolepsy. The primary efficacy outcome was improved sleep quality, whereas secondary outcomes were reduced nocturnal arousals and sleep stage shifts with an overall refreshed sleep nature. Analyses used RevMan 5.3 software, and SMD (standardized mean differences) with 95 % CI (confidence intervals) were calculated. Risk and publication biases were measured with Cochrane risk of bias tools and Comprehensive Meta-Analysis Software. Evidence certainty was measured using GRADEpro.
Results:
Four RCT involving 1079 participants were analyzed for said outcomes, and relevant forest plots were generated. Statistical analysis showed a substantial improvement in sleep quality [SMD = 0.74(95%Cl:0.53,0.95; p < 0.00001; I2 = 0 %; (high certainty)] and refreshing nature of sleep [SMD = 0.81(95%CI:0.51,1.11; P < 0.00001; I2 = 0 %; (moderate certainty)], reduction in nocturnal arousals [SMD = -0.62(95%CI: 0.92,-0.32; p < 0.00001; I2 = 0 %; (moderate certainty)] and sleep stage shifts [SMD = -1.22(95%CI: 1.46,-0.98; p < 0.00001; I2 = 0 %; (high certainty)]. The risk of bias was located high for one study. Symmetrical funnel plots and Egger's regression intercepts testified to no significant publication bias.
Conclusions:
The results showed that sodium oxybate considerably improved the quality of nocturnal sleep, resulting in substantial restorative advantages as well as a decrease in nocturnal arousals and sleep stage transitions. Significant results with low heterogeneity and p-values <0.05, showing consistent effects, were obtained from the analysis. However, overall reliability may be impacted by a high risk of bias in one study.
2025-08-01·FOOD AND CHEMICAL TOXICOLOGY
Associations of acrylamide biomarkers with reproductive lifespan: A cross-sectional study in U.S. women
Article
作者: Guo, Yongzhen ; Zeng, Xianxu ; Li, Junying ; Chen, Chen ; Zhang, Pei ; Bao, Zhuo ; Cao, Yushan ; Liu, Yixuan ; Yan, Jinxiang ; Dong, Xing
Acrylamide (AA), a potential carcinogen mainly present in thermally processed carbohydrate-rich foods, and cigarette smoke, forms acrylamide-hemoglobin adducts (HbAA) and its metabolite glycidamide-hemoglobin adducts (HbGA). Female reproductive lifespan (from menarche to menopause) is the key to women's health management and disease prevention. The reproductive lifespan of US women has shifted, but epidemiological research on its causes is lacking. This cross-sectional study included 1275 naturally postmenopausal women from four cycles of the US National Health and Nutrition Examination Survey, with a mean age of 61 ± 12 years. We examined the associations between HbAA, HbGA, the ratio of HbGA to HbAA (HbGA/HbAA) with female reproductive lifespan using linear regressions, restricted cubic splines (RCS) models, and threshold effect analyses. Results showed that HbAA and HbGA levels below 36.6 and 44.7 pmol/gHb showed no significant association with reproductive lifespan, but above these levels, the negative associations with reproductive lifespan strengthened. After adjusting for all covariates, each 2.7 - fold increase (one ln unit) in HbAA and HbGA was associated with a reduction in reproductive lifespan of 1.4 years (P = 0.003) and 2 years (P = 0.007) respectively. Higher levels of HbAA and HbGA shorten reproductive lifespan, while HbGA/HbAA showed no significant association. CLINICAL TRIAL: not applicable.
2025-07-01·METABOLIC ENGINEERING
Engineering Halomonas bluephagenesis for pilot production of terpolymers containing 3-hydroxybutyrate, 4-hydroxybutyrate and 3-hydroxyvalerate from glucose
Article
作者: Wu, Fuqing ; Hu, Qitiao ; Jer, Ng Wuh ; Xu, Geyuan ; Zheng, Shuang ; Yang, Shimao ; Chen, Guo-Qiang ; Wu, Qiong ; Zhang, Zhongnan ; He, Hongtao ; Sun, Simian
Microbial poly(3-hydroxybutyrate-co-4-hydroxybutyrate-co-3-hydroxyvalerate), abbreviated as P(3HB-4HB-3HV) or P34HBHV, is a flexible polyhydroxyalkanoate (PHA) material ranging from softness to elasticity depending on the ratios of various monomers. Halomonas bluephagenesis, as the chassis of the next generation industrial biotechnology (NGIB) able to grow contamination free under open unsterile conditions. The resulting recombinants of H. bluephagenesis became capable of efficiently synthesizing P34HBHV utilizing glucose as the sole carbon source. Engineered H. bluephagenesis H1 (encoding ogdA, sucD, 4hbD, orfZ, scpA and scpB in chromosomes) transformed with a plasmid containing PHA synthesis genes phaC and phaA and its derivative H29 produced up to 92 % P(3HB-co-8.85 %4HB-co-8.47 %3HV) and 72 % P(3HB-co-13.21 %4HB-co-11.97 %3HV) in cell dry weight (CDW), respectively, in shake flasks. In bioreactor cultivation, H. bluephagenesis H39 constructed by integrating the 4hbD, phaC and phaA genes into the genome of H. bluephagenesis H1 achieved 95 g/L CDW with 69 % P(3HB-co-10.49 %4HB-co-3.54 %3HV), while H. bluephagenesis H43, further optimized with lpxM deletion, reached 73 g/L CDW with 78 % P(3HB-co-10.35 %4HB-co-4.54 %3HV) in a 100 L bioreactor. For the first time, H. bluephagenesis was successfully engineered to generate stable and hyperproductive derivative strains for pilot production of P(3HB-4HB-3HV) with customizable monomer ratios from glucose as the sole carbon source.
217
项与 羟丁酸钠 相关的新闻（医药）2025-06-09
First presentation of the Phase 4 XYLO switch study reports blood pressure reductions in patients with narcolepsy when switching from twice-nightly high- to low-sodium oxybate
Novel intermediate analysis from the DUET trial cohort of patients taking >9 grams evaluated safety and changes in daytime sleepiness in adults with narcolepsy taking Xywav dosages of 9-12 grams per night
For U.S. media and investors only
DUBLIN, June 9, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced late-breaking Phase 4 data evaluating treatment benefits of Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution in people with narcolepsy. These results are two of Jazz's four late-breaking abstracts presented today as oral presentations at SLEEP 2025. The four late-breaking abstracts, selected for their scientific quality and innovation, comprise all industry-sponsored late-breaking oral presentations selected by the Associated Professional Sleep Societies (APSS). Xywav is the only low-sodium oxybate approved by the U.S. Food and Drug Administration for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy and for adults with idiopathic hypersomnia. The Xywav label recommends a nightly dose of 6-9 grams per night.
"People living with narcolepsy have an increased risk of developing cardiovascular and cardiometabolic comorbidities," said Richard J. Kovacs, MD, MACC, Chief Medical Officer, American College of Cardiology and Q.E. and Sally Russell Professor of Cardiology, Indiana University School of Medicine, and XYLO Steering Committee member. "Results from the XYLO study reinforce the importance of monitoring cardiovascular indicators, including blood pressure, and the need to minimize exposure to excess sodium in this at-risk population. Reducing cardiovascular risk and disease is an important goal for all healthcare providers."
"People with narcolepsy live with a complex, severe disorder and often must combat excessive daytime sleepiness and associated symptoms — but the challenges they face are not only limited to sleep," said Kelvin Tan, MB BCh, MRCPCH, chief medical affairs officer of Jazz Pharmaceuticals. "Results from the XYLO interim analysis add to the overwhelming body of evidence demonstrating the positive implications of limiting unnecessary sodium intake, and emphasize how choosing low-sodium oxybate, Xywav, rather than twice-nightly high-sodium oxybate helps reduce excessive sodium burden, a modifiable risk factor for cardiovascular disease, in people with narcolepsy."
Phase 4 XYLO Results Show Impact of Switching from Twice-Nightly High- to Low-Sodium Oxybate on Ambulatory Blood Pressure in People with Narcolepsy
The open-label, single arm Phase 4 XYLO switch trial (n=43) met its primary endpoint of change in mean 24-hour ambulatory systolic blood pressure (SBP) from baseline (taking twice-nightly high-sodium oxybate) to end-of-treatment (after six weeks on low-sodium oxybate, Xywav), with a −4.1 (−6.9, −1.4; P=0.0019) mmHg change. These results show that switching from twice-nightly high-sodium oxybate to the same dosage of low-sodium oxybate, Xywav, for approximately 6 weeks reduced daily treatment-related sodium intake and was associated with clinically meaningful blood pressure reductions in participants with narcolepsy, which was paralleled by 24-hour urinary sodium reduction. XYLO results are consistent with the extensive body of evidence on the benefits of reducing sodium intake.
The study also achieved key secondary endpoints, including mean change in ambulatory daytime SBP (-5.1 mmHg; P=0.0003) and mean change in seated resting (in-office) SBP (-9.2 mmHg; (P<0.0001). The change in mean nighttime ambulatory SBP was −2.0 (P=0.1265) mmHg. Exploratory endpoints evaluated change in 24-hour, daytime ambulatory, seated resting, and nighttime ambulatory diastolic blood pressure.
Overall, treatment-emergent adverse events (TEAEs) occurred in 32.8% of participants and were all mild or moderate in severity and consistent with the known safety profile of Xywav.
Phase 4 DUET Data Evaluated Effectiveness and Safety of Xywav in Adults with Narcolepsy Taking Dosages of 9-12 Grams
This intermediate analysis, which evaluates a cohort of adults with narcolepsy from the DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial, demonstrated improvements in EDS on the Epworth Sleepiness Scale, the study's primary endpoint, in 24 participants taking 9-12 grams of Xywav twice-nightly, as compared to 9 grams at baseline. The current recommended dosage of Xywav for adults with narcolepsy is 6-9 grams per night. Following dose optimization, the average Xywav dose during the stable-dose period was 11.2 g/night.
Participants with narcolepsy in this intermediate cohort analysis also experienced improvements on the Narcolepsy Severity Scale. Additionally, participants showed minimal changes in the number of central apnea events, mean oxygen saturation (SpO2) levels, or the mean percent of total sleep time with SpO2 <90% from BL to EOT.
The DUET trial is a Phase 4, prospective, single-arm, open-label study to assess the effect of Xywav treatment on EDS, polysomnography parameters, and functional outcomes in adults with narcolepsy or IH. Overall, TEAEs were all mild or moderate and consistent with the known safety profile of Xywav at lower dosages.
The full abstracts will be available online at sleepmeeting.org/abstract-supplements.
About Narcolepsy
Narcolepsy is a chronic, debilitating neurologic sleep disorder characterized by the inability to maintain continuous sleep at night and sustained wakefulness throughout the day. This leads to symptoms that can include fragmented or disrupted nighttime sleep, excessive daytime sleepiness, and cataplexy.1 Patients with EDS due to narcolepsy experience sleep attacks, called cataplexy, and, despite fighting the urge to sleep, may unintentionally fall asleep for short periods.2,3 These sleep attacks may happen at inappropriate or potentially dangerous times such as during driving, cycling, eating, or mid-conversation.4
There is no cure for narcolepsy, therefore this EDS is lifelong and has a substantial negative impact on a person's ability to function psychologically, socially and professionally.5 Patients with narcolepsy are at increased risk for hypertension, cardiometabolic morbidity, stroke, myocardial infarction, heart failure, cardiac arrest, and death.6,7,8,9 As narcolepsy is a chronic condition that requires lifelong, nightly treatment, early access to an effective, low-sodium treatment can transform lives and reduce the impact of narcolepsy on a person's physical and mental health.5
About Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution
Xywav is the only low-sodium oxybate approved by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. The Office of Orphan Product Development (OOPD) at the FDA also published its summary of clinical superiority findings for Xywav for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy by means of greater cardiovascular safety compared to Xyrem® (sodium oxybate) oral solution. The decision of the OOPD is based on the FDA findings that Xywav provides a greatly reduced chronic sodium burden compared to Xyrem. Xywav has 131 mg of sodium at the maximum recommended nightly dose whereas other high sodium oxybates have 1640 mg at the equivalent dose. Xywav is comprised of a unique composition of cations resulting in 92% less sodium, or a reduction of approximately 1,000 to 1,500 mg/night at the recommended dose range of 6 g to 9 g/night. Xywav is the only oxybate therapy that does not carry a warning in the label related to use in patients sensitive to high sodium intake.
Xywav is also the first and only U.S. FDA-approved treatment option for idiopathic hypersomnia in adults. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of idiopathic hypersomnia in adults. Xywav is the only FDA-approved treatment studied across the multiple symptoms of idiopathic hypersomnia, such as EDS, sleep inertia (severe grogginess or confusion when waking up), long sleep duration and cognitive impairment. Xywav can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults.
The exact mechanism of action of Xywav in the treatment of adults with idiopathic hypersomnia and of cataplexy and EDS in narcolepsy is unknown. It is hypothesized that the therapeutic effects of Xywav are mediated through GABAB actions during sleep at noradrenergic and dopaminergic neurons, as well as thalamocortical neurons.10 The U.S. Drug Enforcement Agency (DEA) has designated Xywav as a Schedule III medicine. The DEA defines Schedule III drugs, substances, or chemicals as drugs with a moderate to low potential for physical and psychological dependence.10,11 Because of the risks of central nervous system (CNS) depression and abuse and misuse, Xywav is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS.
Important Safety Information for Xywav
Contraindications
XYWAV is contraindicated
in combination with sedative hypnotics or alcohol and
in patients with succinic semialdehyde dehydrogenase deficiency.
Warnings and Precautions
Central Nervous System Depression
The concurrent use of XYWAV with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. If use of these CNS depressants in combination with XYWAV is required, dose reduction or discontinuation of one or more CNS depressants (including XYWAV) should be considered. In addition, if short-term use of an opioid (eg, post- or perioperative) is required, interruption of treatment with XYWAV should be considered.
After first initiating treatment and until certain that XYWAV does not affect them adversely (eg, impair judgment, thinking, or motor skills), caution patients against hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes. Also caution patients against these hazardous activities for at least 6 hours after taking XYWAV. Patients should be queried about CNS depression-related events upon initiation of XYWAV therapy and periodically thereafter.
Abuse and Misuse
XYWAV is a Schedule Ill controlled substance. The active moiety of XYWAV is oxybate, also known as gamma-hydroxybutyrate (GHB), a Schedule I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The rapid onset of sedation, coupled with the amnestic features of GHB particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (eg, assault victim). Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.
XYWAV
and
XYREM
REMS
Because of the risks of central nervous system depression and abuse and misuse, XYWAV is available only through a restricted distribution program called the XYWAV and XYREM REMS.
Notable requirements of the XYWAV and XYREM REMS include the following:
Healthcare Providers who prescribe XYWAV are specially certified
XYWAV will be dispensed only by the central pharmacy that is specially certified
XYWAV will be dispensed and shipped only to patients who are enrolled in the XYWAV and XYREM REMS with documentation of safe use
Further information is available at or 1-866-997-3688.
Respiratory Depression and Sleep-Disordered Breathing
XYWAV may impair respiratory drive, especially in patients with compromised respiratory function. In overdoses of oxybate and with illicit use of GHB, life-threatening respiratory depression has been reported. Increased apnea and reduced oxygenation may occur with XYWAV administration in adult and pediatric patients. A significant increase in the number of central apneas and clinically significant oxygen desaturation may occur in patients with obstructive sleep apnea treated with XYWAV. Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients, in men, in postmenopausal women not on hormone replacement therapy, and among patients with narcolepsy.
Depression and Suicidality
In Study 1, the randomized-withdrawal clinical trial in adult patients with narcolepsy (n=201), depression and depressed mood were reported in 3% and 4%, respectively, of patients treated with XYWAV. Two patients (1%) discontinued XYWAV because of depression. In most cases, no change in XYWAV treatment was required.
In Study 2, the randomized-withdrawal clinical trial in adult patients with idiopathic hypersomnia (n=154), depression and depressed mood were reported in 1% and 3%, respectively, of patients treated with XYWAV. All patients continued XYWAV treatment.
Two suicides and two attempted suicides occurred in adult clinical trials with oxybate (same active moiety as XYWAV). One patient experienced suicidal ideation and two patients reported depression in a pediatric clinical trial with oxybate. These events occurred in patients with and without previous histories of depressive disorders. The emergence of depression in patients treated with XYWAV requires careful and immediate evaluation. Monitor patients for the emergence of increased depressive symptoms and/or suicidality while taking XYWAV.
Other Behavioral or Psychiatric Adverse Reactions
In Study 1, confusion and anxiety occurred in 1% and 5% of patients with narcolepsy treated with XYWAV, respectively. One patient experienced visual hallucinations and confusion after ingesting approximately 9 grams of XYWAV.
In Study 2, confusion and anxiety occurred in 3% and 16% of patients with idiopathic hypersomnia, respectively. One patient experienced visual hallucinations, which led to discontinuation of XYWAV.
Other neuropsychiatric reactions reported with oxybate (same active moiety as XYWAV) in adult or pediatric clinical trials and in the postmarketing setting include hallucinations, paranoia, psychosis, aggression, agitation, confusion and anxiety. The emergence or increase in the occurrence of behavioral or psychiatric events in patients taking XYWAV should be carefully monitored.
Parasomnias
Parasomnias can occur in patients taking XYWAV.
In Study 1 and Study 2, parasomnias, including sleepwalking, were reported in 6% and 5% of adult patients treated with XYWAV, respectively.
In a clinical trial of XYREM (same active moiety as XYWAV) in adult patients with narcolepsy, five instances of sleepwalking with potential injury or significant injury were reported. Parasomnias, including sleepwalking, have been reported in a pediatric clinical trial with sodium oxybate (same active moiety as XYWAV) and in postmarketing experience with sodium oxybate.
Episodes of sleepwalking should be fully evaluated and appropriate interventions considered.
Most Common Adverse Reactions
The most common adverse reactions (occurring in ≥5% of XYWAV-treated patients in adult clinical trials in either narcolepsy or IH) were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.
In the pediatric clinical trial with XYREM (same active moiety as XYWAV) that included pediatric patients 7 to 17 years of age with narcolepsy, the most common adverse reactions (≥5%) were nausea (20%), enuresis (19%), vomiting (18%), headache (17%), weight decreased (13%), decreased appetite (9%), dizziness (8%), and sleepwalking (6%). The overall adverse reaction profile of XYREM in the pediatric clinical trial was similar to that seen in the adult clinical trial program. The safety profile in pediatric patients with XYWAV is expected to be similar to that of adult patients treated with XYWAV and to that of pediatric patients treated with XYREM.
Additional Adverse Reactions
Adverse reactions that occurred in 2-<5% of adult patients treated with XYWAV in the Open Label Titration and Stable Dose Periods of the randomized-withdrawal study in adult patients with narcolepsy with cataplexy (Study 1) were fatigue, dry mouth, depressed mood, enuresis, irritability, paresthesia, depression, tremor, somnolence, and muscle spasms. Adverse reactions occurring in 2-<5% of patients treated with XYWAV in the IH study include balance disorder, muscle spasms, fall, paresthesia, snoring, weight decreased, bruxism, confusional state, depressed mood, feeling drunk, and irritability.
Adverse reactions that occurred in ≥2% of patients in clinical studies with oxybate (but not in Study 1) and which may be relevant for XYWAV, were pain, feeling drunk, pain in extremity, cataplexy, disturbance in attention, sleep paralysis, and disorientation.
Discontinuation: In Study 1, 9 of 201 patients (4%) reported adverse reactions that led to withdrawal from the study (anxiety, decreased appetite, depressed mood, depression, fatigue, headache, irritability, nausea, pain in extremity, parasomnia, somnolence, and vomiting). The most common adverse reaction leading to discontinuation was nausea (1.5%). In Study 2, 17 of 154 (11%) patients across all study periods (excluding placebo during the DB RWP) (up to 42 weeks) reported adverse reactions that led to withdrawal from the study (anxiety, nausea, insomnia, vomiting, fatigue, feeling abnormal, fall, decreased appetite, dizziness, paresthesia, tremor, parasomnia, confusional state, hallucination visual, and irritability). The most common adverse reaction leading to discontinuation was anxiety (3.2%). In Study 1 and Study 2, the majority of adverse reactions leading to discontinuation began during the first few weeks of treatment.
In the pediatric clinical trial with XYREM (same active moiety as XYWAV), 7 of 104 patients reported adverse reactions that led to withdrawal from the study (hallucination, tactile; suicidal ideation; weight decreased; sleep apnea syndrome; affect lability; anger, anxiety, depression; and headache).
Drug Interactions
XYWAV is contraindicated in combination with alcohol or sedative hypnotics. Use of other CNS depressants may potentiate the CNS-depressant effects of XYWAV.
Concomitant use of sodium oxybate with divalproex sodium results in an increase in systemic exposure to GHB, which was shown to cause a greater impairment on some tests of attention and working memory in a clinical study. A similar increase in exposure is expected with concomitant use of XYWAV and divalproex sodium; therefore, an initial dose reduction of XYWAV is recommended when used concomitantly with divalproex sodium. Prescribers are advised to monitor patient response closely and adjust dose accordingly if concomitant use of XYWAV and divalproex sodium is warranted.
Pregnancy and Lactation
There are no adequate data on the developmental risk associated with the use of XYWAV or sodium oxybate in pregnant women. XYWAV should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. GHB is excreted in human milk after oral administration of sodium oxybate. There is insufficient information on the risk to a breastfed infant, and there is insufficient information on milk production in nursing mothers. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XYWAV and any potential adverse effects on the breastfed infant from XYWAV or from the underlying maternal condition.
Pediatric Use
The safety and effectiveness of XYWAV for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy have been established. XYWAV has not been studied in a pediatric clinical trial for narcolepsy or IH. Use of XYWAV in pediatric patients 7 years of age and older with narcolepsy is supported by evidence from an adequate and well-controlled study of sodium oxybate in pediatric patients 7 to 17 years of age, a study in adults showing a treatment effect of XYWAV similar to that observed with sodium oxybate, pharmacokinetic data of sodium oxybate from adult and pediatric patients, and pharmacokinetic data of XYWAV from healthy adult volunteers.
Safety and effectiveness of XYWAV in pediatric patients below the age of 7 years with narcolepsy have not been established.
Safety and effectiveness of XYWAV for the treatment of idiopathic hypersomnia in pediatric patients have not been established.
Geriatric Use
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Hepatic Impairment
The starting dose of XYWAV should be reduced in patients with liver impairment.
Dosage Modification in Patients with Hepatic Impairment: The recommended starting dosage in patients with hepatic impairment is one-half of the original dosage per night, administered orally, divided into two doses.
Dependence and Tolerance
There have been case reports of withdrawal, ranging from mild to severe, following discontinuation of illicit use of GHB at frequent repeated doses (18 g to 250 g per day) in excess of the recommended dosage range. Signs and symptoms of GHB withdrawal following abrupt discontinuation included insomnia, restlessness, anxiety, psychosis, lethargy, nausea, tremor, sweating, muscle cramps, tachycardia, headache, dizziness, rebound fatigue and sleepiness, confusion, and, particularly in the case of severe withdrawal, visual hallucinations, agitation, and delirium. These symptoms generally abated in 3 to 14 days. In cases of severe withdrawal, hospitalization may be required.
In the clinical trial experience with XYREM in narcolepsy/cataplexy patients at recommended doses, two patients reported anxiety and one reported insomnia following abrupt discontinuation at the termination of the clinical trial; in the two patients with anxiety, the frequency of cataplexy had increased markedly at the same time. In the XYWAV clinical trial in adult narcolepsy/cataplexy patients at recommended doses, one patient reported insomnia following abrupt discontinuation of XYWAV. In the XYWAV clinical trial in adult idiopathic hypersomnia patients at recommended doses, six patients reported insomnia, two patients reported early insomnia, and one patient reported visual and auditory hallucinations following abrupt discontinuation of XYWAV.
Tolerance to XYWAV has not been systematically studied in controlled clinical trials. There have been some case reports of symptoms of tolerance developing after illicit use at dosages far in excess of the recommended XYWAV dosage regimen.
Please see full Prescribing Information, including BOXED Warning here:
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information.
Contacts:
Media:
Kristin Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
[email protected]
Ireland +353 1 637 2141
U.S. +1 215 867 4948
Investors:
Jeff Macdonald
Executive Director, Investor Relations
Jazz Pharmaceuticals plc
[email protected]
Ireland +353 1 634 3211
U.S. +1 650 496 2717
References:
Sateia, M. J. (2023). International Classification of Sleep Disorders-Third Edition, Text Revision (ICSD-3-TR). Chest, 146(5), 1387–1394. PubMed. .
Dauvilliers Y, Arnulf I, Mignot E. Narcolepsy with cataplexy. Lancet. 2007;369(9560):499-511.
Colten HR, Altevogt BM, Institute of Medicine (US) Committee on Sleep Medicine and Research, eds. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Washington (DC): National Academies Press (US); 2006.
Peacock J, Benca RM. Narcolepsy: clinical features, co-morbidities & treatment. Indian Journal of Medical Research. 2010;131(2):338-349.
National Health Service. Narcolepsy – Overview. 2019. . Accessed June 2025.
Ben-Joseph RH, Saad R, Black J, et al. Cardiovascular burden of narcolepsy disease (CV-BOND): a real-world evidence study. Presented at: 2022 AAN Annual Meeting; April 2-7; Seattle, Washington. Poster 1203.
Black J, Reaven NL, Funk SE, et al. Medical comorbidity in narcolepsy: findings from the Burden of Narcolepsy Disease (BOND) study. Sleep Med. 2017;33:13-18.
Ohayon MM, Black J, Lai C, et al. Increased mortality in narcolepsy. Sleep. 2014;37(3):439-444.
Ohayon MM. Narcolepsy is complicated by high medical and psychiatric comorbidities: a comparison with the general population. Sleep Med. 2013;14(6):488-492.
Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution. Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2021.
United States Drug Enforcement Agency. Drug Scheduling. . Accessed June 2025.
SOURCE Jazz Pharmaceuticals plc
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临床结果临床3期上市批准孤儿药临床2期
2025-06-05
DUBLIN, June 05, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that LUMRYZTM has been granted Orphan Drug Designation (ODD) from the U.S. Food & Drug Administration (FDA) for the treatment of Idiopathic Hypersomnia (IH). Specifically, ODD was granted based on the plausible hypothesis that LUMRYZ may be clinically superior to the same drug(s) already approved for the same indication, because LUMRYZ may provide a major contribution to patient care due to its once-nightly dosing for patients with IH, a chronic sleep disorder that requires potentially lifelong treatment. "We are pleased that LUMRYZ has been granted Orphan Drug Designation for the treatment of IH, and this recognition reinforces our strategy to develop differentiated therapies for patients with rare sleep disorders," said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. "Receipt of ODD highlights the unique value of our next-generation, extended-release oxybate and its potential for IH patients, if approved. We continually hear from clinicians and patients of the substantial need for an extended-release oxybate for this patient population – a population who suffers from profound sleep inertia, making waking up in the middle of the night an even greater challenge than in narcolepsy. With continued progress in our pivotal Phase 3 REVITALYZ trial, an established commercial foundation in narcolepsy, and a relentlessly devoted team, we are well-positioned to advance LUMRYZ in IH with the goal of ultimately transforming the IH treatment landscape, if approved.” IH is a rare and debilitating sleep disorder characterized by excessive daytime sleepiness not attributable to any other medical conditions. LUMRYZ is currently being evaluated for the treatment of IH in the REVITALYZ™ trial, which is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed to evaluate the efficacy and safety of LUMRYZ when given as a once-at-bedtime dose. The study will enroll approximately 150 adults who are diagnosed with IH. REVITALYZ enrollment is open for both participants switching from immediate-release oxybates as well as those not currently taking oxybates, and is on track to be completed by year end 2025. Orphan Drug Designation is granted by the FDA to support drug development for rare diseases and is assigned to drugs and biologics that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people in the U.S. The designation can provide several benefits for the development and commercialization of indicated compounds and medicines which include eligibility for a seven-year period of market exclusivity in the U.S. following product approval, FDA assistance in clinical trial design and an exemption from FDA user fees. About LUMRYZ™ (sodium oxybate) for extended-release oral suspension LUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. On October 16, 2024, LUMRYZ was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in pediatric patients 7 years of age and older with narcolepsy. The FDA approval of LUMRYZ was supported by results from REST-ON™, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS (MWT), clinicians’ overall assessment of patients’ functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo. With its approvals in May 2023 and October 2024, the FDA also granted 7 years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy and in pediatric patients 7 years of age and older with narcolepsy (respectively) due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose. LUMRYZ is only currently approved for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy, and Avadel does not sell LUMRYZ for any indication beyond narcolepsy. INDICATIONSLUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients 7 years of age and older with narcolepsy: sudden onset of weak or paralyzed muscles (cataplexy)excessive daytime sleepiness (EDS) IMPORTANT SAFETY INFORMATION WARNING: Taking LUMRYZ™ (sodium oxybate) with other central nervous system (CNS) depressants, such as medicines used to make you fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope) and death.The active ingredient of LUMRYZ (sodium oxybate) is a form of gamma hydroxybutyrate (GHB), a controlled substance. Abuse or misuse of illegal GHB alone or with other CNS depressants (drugs that cause changes in alertness or consciousness) have caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma and death. Call your doctor right away if you have any of these serious side effects.Because of these risks, LUMRYZ is available only by prescription and filled through certified pharmacies in the LUMRYZ REMS. You must be enrolled in the LUMRYZ REMS to receive LUMRYZ. Further information is available at www.LUMRYZREMS.com or by calling 1-877-453-1029. Do not take LUMRYZ if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol or have a rare problem called succinic semialdehyde dehydrogenase deficiency. Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling or giving away LUMRYZ may harm others and is against the law. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs. Anyone who takes LUMRYZ should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery or flying an airplane, for at least six (6) hours after taking LUMRYZ. Those activities should not be done until you know how LUMRYZ affects you. Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized. LUMRYZ can cause serious side effects, including the following: Breathing problems, including slower breathing, trouble breathing and/or short periods of not breathing while sleeping (e.g., sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take LUMRYZ.Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness and difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself. Call your doctor right away if you or your child have symptoms of mental health problems or a change in weight or appetite.Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you or your child start sleepwalking. Tell your doctor if you or your child are on a salt-restricted diet or have high blood pressure, heart failure or kidney problems. LUMRYZ contains a lot of sodium (salt) and may not be right for you. The most common side effects of LUMRYZ in adults include nausea, dizziness, bedwetting, headache and vomiting. Your side effects may increase when you take higher doses of LUMRYZ. The most common side effects in children include nausea, bedwetting, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking. LUMRYZ can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of LUMRYZ. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see full Prescribing Information, including BOXED Warning, and Medication Guide. About Avadel Pharmaceuticals plc Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. For more information, please visit www.avadel.com. Avadel intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcast. Cautionary Disclosure Regarding Forward-Looking StatementsThis press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, expectations regarding the Company’s strategy to develop differentiated therapies for patients with rare sleep disorders, including IH; expectations regarding LUMRYZ’s ability to transform the IH treatment landscape; expectations regarding potential FDA approval and subsequent commercialization of LUMRYZ for the treatment of IH; the potential benefits of orphan drug designation; and the progress, timing and success of the REVITALYZ trial, including expectations for enrollment. In some cases, forward-looking statements can be identified by use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions and the negatives thereof (if applicable). The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law. Investor Contact:Austin MurtaghPrecision AQAustin.Murtagh@precisionaq.com(212) 698-8696 Media Contact:Lesley StanleyReal Chemistrylestanley@realchemistry.com(609) 273-3162
临床3期孤儿药上市批准临床结果
2025-05-29
Nineteen abstracts, including eleven late-breaking abstracts, underscore Jazz's leadership and extensive research in sleep medicine, and ongoing commitment to advancing the treatment of narcolepsy and idiopathic hypersomnia
For U.S. media and investors only
DUBLIN , May 29, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that nineteen abstracts, including eleven late-breaking abstracts will be presented at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies (APSS) being held June 8-11, 2025 , in Seattle .
Research to be presented at the meeting include dual late-breaking poster and oral presentations, which highlight the extensive Phase 4 data evaluating the effectiveness of low-sodium oxybate, Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution in patients with narcolepsy and idiopathic hypersomnia (IH). These presentations include the first interim results from the open-label, single arm XYLO trial that evaluated ambulatory and office blood pressure changes in patients with narcolepsy after switching from a twice-nightly high-sodium oxybate oral solution to low-sodium oxybate, Xywav. Two additional presentations share novel results from the open-label, single arm DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial, which assessed Xywav on multiple sleep parameters, including the first presentation of polysomnography (PSG) outcomes in adults with IH. Additional data evaluated the effectiveness and safety of Xywav in a cohort of narcolepsy patients whose doses were optimized to greater than 9 grams (with twice-nightly dosing). The Xywav label recommends a maximum nightly dose of 9 grams per night.
"Jazz prioritizes a holistic approach to patient health, continuously deepening our understanding of how to support patients with challenging sleep disorders, as well as mitigate associated comorbidities," said Kelvin Tan, MB BCh, MRCPCH, chief medical affairs officer of Jazz Pharmaceuticals. "The extensive research presented at SLEEP 2025, underscores our commitment to patient-centric care, including the development of low-sodium Xywav, which is particularly important given the impact of sodium intake and existing cardiovascular risks among patients with narcolepsy or idiopathic hypersomnia."
Additional highlights at SLEEP 2025 include:
Two late-breaking poster presentations describing results from the CHIME study, which evaluated real-world, patient-reported outcomes, including treatment adherence, effectiveness, and satisfaction among adults with narcolepsy or IH (reported separately) taking Xywav. A late-breaking claims analysis that describes self-reported prevalence, severity, and impact of sleep inertia among individuals diagnosed with IH. Two additional late-breaking poster presentations showcasing findings from INTREPID, a retrospective cohort study that examined Optum Market Clarity data from 2007–2023 to assess treatment patterns and changes in alerting agent claims among patients with narcolepsy or IH during the full study period and following the approval of Xywav. Two poster presentations showcasing sleep architecture results from the DUET trial, which demonstrated the effectiveness of Xywav on improvements in sleep quality among patients with IH or narcolepsy. Two poster presentations report interim results from the LYRICAL study, which examined real-world and patient-reported data showing patients in both the narcolepsy and IH cohorts taking Xywav experience symptom improvements, improved quality of life and high global treatment satisfaction.
The SLEEP 2025 abstracts are available online at sleepmeeting.org/abstract-supplements.
A full list of Jazz Pharmaceuticals' presentations follows below:
Presentation Title
Lead Author
Presentation Type & Number / Session / Date & Time (PT)
Dual Presentations
Nocturnal Spontaneous Arousals in PeopleWith Narcolepsy and Idiopathic HypersomniaFollowing Treated With Low-Sodium Oxybate
C Ruoff
Oral Presentation Session: LBA-02 (NON-CME)
Oral Presentation Date and Time: June 9 , 2025, 2:15 –2:30 p.m.
Poster #: 556
Poster Presentation Session: P-37
Session Date/Time: June 10 , 2025,10:00 – 11:45 a.m.
Prevalence and Severity of Sleep Inertia Among Individuals With Idiopathic Hypersomnia
JK Alexander
Oral Presentation Session: LBA-02 (NON-CME)
Oral Presentation Date and Time: June 9 , 2025, 2:30 –2:45 p.m.
Poster #: 557
Poster Presentation Session: P-37
Session Date/Time: June 10 , 2025,10:00 – 11:45 AM
Impact of Switching From High- to Low-Sodium Oxybate on Ambulatory Blood Pressure in Patients With Narcolepsy
VK Somers
Oral Presentation Session: LBA-02 (NON-CME)
Oral Presentation Date and Time: June 9 , 2025, 2:45 –3:00 p.m.
Poster #: 554
Poster Presentation Session: P-37
Session Date/Time: June 10 , 2025,10:00 – 11:45 AM
Effectiveness and Safety of Low-Sodium Oxybate Dosages Greater Than 9 Grams in Study Participants With Narcolepsy
JH Simmons
Oral Presentation Session: LBA-02 (NON-CME)
Oral Presentation Date and Time: June 9 , 2025, 3:00 –3:15 p.m.
Poster #: 558
Poster Presentation Session: P-37
Session Date/Time: June 10 , 2025,10:00 – 11:45 AM
Effectiveness and Safety of Low-Sodium Oxybate in Participants With Narcolepsy: Results From the DUET Study
LD Schneider
Oral Presentation Session: O-24
Oral Presentation Date and Time: June 11, 2025 , 4:30 –4:45 p.m.
Poster #: 393
Poster Presentation Session: P-51
Session Date/Time: June 11 , 2025,10:00 –11:45 AM
Late-Breaking Presentations
Sodium-Associated Comorbidity Risk Profiles in Individuals With Narcolepsy and Idiopathic Hypersomnia in the US
SC Markt
Poster #: 545
Poster Presentation Session: P-37
Session Date/Time: June 10 , 2025,10:00 –11:45 a.m.
Narcolepsy Treatment Trends and Change in Alerting Agent Use After Low-Sodium Oxybate Initiation
SC Markt
Poster #: 551
Poster Presentation Session: P-37
Session Date/Time: June 10 , 2025,10:00 –11:45 a.m.
Idiopathic Hypersomnia Treatment Trends and Change in Alerting Agent Use After Low-Sodium Oxybate Initiation
M Whalen
Poster #: 552
Poster Presentation Session: P-37
Session Date/Time: June 10 , 2025,10:00 –11:45 a.m.
Social Determinants of Health and Clinical Burden in Narcolepsy: A Retrospective Cohort Analysis
A Zhou
Poster #: 533
Poster Presentation Session: P-37
Session Date/Time: June 10 , 2025,10:00 –11:45 a.m.
Real-World Surveys of Treatment Effectiveness and Satisfaction in Adults With Narcolepsy Taking Low-Sodium Oxybate
J Yu
Poster #: 535
Poster Presentation Session: P-37
Session Date/Time: June 10 , 2025,10:00 –11:45 a.m.
Real-World, Participant-Reported Effectiveness and Satisfaction with Low-Sodium Oxybate in Idiopathic Hypersomnia
J Yu
Poster #: 534
Poster Presentation Session: P-37
Session Date/Time: June 10 , 2025,10:00 –11:45 a.m.
Demographic and Clinical Characteristics in Narcolepsy and Idiopathic Hypersomnia at Treatment Initiation
VK Somers
Poster #: 536
Poster Presentation Session: P-37
Session Date/Time: June 10 , 2025,10:00 –11:45 a.m.
Poster Presentations
Effectiveness and Safety of Low-Sodium Oxybate in Idiopathic Hypersomnia Participants: Results From the DUET Study
DT Plante
Poster #: 413
Poster Presentation Session: P-51
Session Date/Time: June 11, 2025 , 10:00 –11:45 a.m.
Subjective Sleep Quality With Low-Sodium Oxybate Treatment in People With Narcolepsy: Results From the DUET Study
RB Sangal
Poster #: 422
Poster Presentation Session: P-51
Session Date/Time: June 11, 2025 , 10:00 –11:45 a.m.
Subjective Sleep Quality With Low-Sodium Oxybate Treatment in Idiopathic Hypersomnia: Results From the DUET Study
RK Bogan
Poster #: 414
Poster Presentation Session: P-51
Session Date/Time: June 11, 2025 , 10:00 –11:45 a.m.
Sleep Architecture With Low-Sodium Oxybate Treatment in Narcolepsy: Results From the DUET Study
C Ruoff
Poster #: 424
Poster Presentation Session: P-51
Session Date/Time: June 11, 2025 , 10:00 –11:45 a.m.
Sleep Architecture With Low-Sodium Oxybate Treatment in Idiopathic Hypersomnia: Results From the DUET Study
A Cairns
Poster #: 415
Poster Presentation Session: P-51
Session Date/Time: June 11, 2025 , 10:00 –11:45 a.m.
Real-World Experience and Satisfaction With Low-Sodium Oxybate in Narcolepsy: Interim Results From LYRICAL
C Drachenberg
Poster #: 420
Poster Presentation Session: P-51
Session Date/Time: June 11, 2025 , 10:00 –11:45 a.m.
Real-World Patient Insights on Low-Sodium Oxybate for Idiopathic Hypersomnia: Interim Results From LYRICAL
C Drachenberg
Poster #: 418
Poster Presentation Session: P-51
Session Date/Time: June 11, 2025 , 10:00 –11:45 AM
About Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solutionXywav is the only low-sodium oxybate approved by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. The Office of Orphan Product Development (OOPD) at the FDA also published its summary of clinical superiority findings for Xywav for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy by means of greater cardiovascular safety compared to Xyrem® (sodium oxybate) oral solution. The decision of the OOPD is based on the FDA findings that Xywav provides a greatly reduced chronic sodium burden compared to Xyrem. Xywav has 131 mg of sodium at the maximum recommended nightly dose whereas other high sodium oxybates have 1640 mg at the equivalent dose. Xywav is comprised of a unique composition of cations resulting in 92% less sodium, or a reduction of approximately 1,000 to 1,500 mg/night at the recommended dose range of 6 g to 9 g/night. Xywav is the only oxybate therapy that does not carry a warning in the label related to use in patients sensitive to high sodium intake.
Xywav is also the first and only U.S. FDA-approved treatment option for idiopathic hypersomnia in adults. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of idiopathic hypersomnia in adults. Xywav is the only FDA-approved treatment studied across the multiple symptoms of idiopathic hypersomnia, such as EDS, sleep inertia (severe grogginess or confusion when waking up), long sleep duration and cognitive impairment. Xywav can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults.
The exact mechanism of action of Xywav in the treatment of adults with idiopathic hypersomnia and of cataplexy and EDS in narcolepsy is unknown. It is hypothesized that the therapeutic effects of Xywav are mediated through GABAB actions during sleep at noradrenergic and dopaminergic neurons, as well as thalamocortical neurons.1 The U.S. Drug Enforcement Agency (DEA) has designated Xywav as a Schedule III medicine. The DEA defines Schedule III drugs, substances, or chemicals as drugs with a moderate to low potential for physical and psychological dependence.1,2 Because of the risks of central nervous system (CNS) depression and abuse and misuse, Xywav is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS.
Important Safety Information for Xywav
WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE.
Central Nervous System DepressionXYWAV is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with XYWAV at recommended doses. Many patients who received XYWAV during clinical trials in narcolepsy and idiopathic hypersomnia were receiving CNS stimulants. Abuse and MisuseThe active moiety of XYWAV is oxybate or gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.
Because of the risks of CNS depression and abuse and misuse, XYWAV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS.
ContraindicationsXYWAV is contraindicated
in combination with sedative hypnotics or alcohol and in patients with succinic semialdehyde dehydrogenase deficiency.
Warnings and PrecautionsCentral Nervous System Depression
The concurrent use of XYWAV with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. If use of these CNS depressants in combination with XYWAV is required, dose reduction or discontinuation of one or more CNS depressants (including XYWAV) should be considered. In addition, if short-term use of an opioid (eg, post- or perioperative) is required, interruption of treatment with XYWAV should be considered.
After first initiating treatment and until certain that XYWAV does not affect them adversely (eg, impair judgment, thinking, or motor skills), caution patients against hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes. Also caution patients against these hazardous activities for at least 6 hours after taking XYWAV. Patients should be queried about CNS depression-related events upon initiation of XYWAV therapy and periodically thereafter.
Abuse and MisuseXYWAV is a Schedule Ill controlled substance. The active moiety of XYWAV is oxybate, also known as gamma-hydroxybutyrate (GHB), a Schedule I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The rapid onset of sedation, coupled with the amnestic features of GHB particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (eg, assault victim). Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.
XYWAV and XYREM REMSBecause of the risks of central nervous system depression and abuse and misuse, XYWAV is available only through a restricted distribution program called the XYWAV and XYREM REMS.
Notable requirements of the XYWAV and XYREM REMS include the following:
Healthcare Providers who prescribe XYWAV are specially certified XYWAV will be dispensed only by the central pharmacy that is specially certified XYWAV will be dispensed and shipped only to patients who are enrolled in the XYWAV and XYREM REMS with documentation of safe use
Further information is available at www.XYWAVXYREMREMS.com or 1-866-997-3688.
Respiratory Depression and Sleep-Disordered BreathingXYWAV may impair respiratory drive, especially in patients with compromised respiratory function. In overdoses of oxybate and with illicit use of GHB, life-threatening respiratory depression has been reported. Increased apnea and reduced oxygenation may occur with XYWAV administration in adult and pediatric patients. A significant increase in the number of central apneas and clinically significant oxygen desaturation may occur in patients with obstructive sleep apnea treated with XYWAV. Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients, in men, in postmenopausal women not on hormone replacement therapy, and among patients with narcolepsy.
Depression and SuicidalityIn Study 1, the randomized-withdrawal clinical trial in adult patients with narcolepsy (n=201), depression and depressed mood were reported in 3% and 4%, respectively, of patients treated with XYWAV. Two patients (1%) discontinued XYWAV because of depression. In most cases, no change in XYWAV treatment was required.
In Study 2, the randomized-withdrawal clinical trial in adult patients with idiopathic hypersomnia (n=154), depression and depressed mood were reported in 1% and 3%, respectively, of patients treated with XYWAV. All patients continued XYWAV treatment.
Two suicides and two attempted suicides occurred in adult clinical trials with oxybate (same active moiety as XYWAV). One patient experienced suicidal ideation and two patients reported depression in a pediatric clinical trial with oxybate. These events occurred in patients with and without previous histories of depressive disorders. The emergence of depression in patients treated with XYWAV requires careful and immediate evaluation. Monitor patients for the emergence of increased depressive symptoms and/or suicidality while taking XYWAV.
Other Behavioral or Psychiatric Adverse ReactionsIn Study 1, confusion and anxiety occurred in 1% and 5% of patients with narcolepsy treated with XYWAV, respectively. One patient experienced visual hallucinations and confusion after ingesting approximately 9 grams of XYWAV.
In Study 2, confusion and anxiety occurred in 3% and 16% of patients with idiopathic hypersomnia, respectively. One patient experienced visual hallucinations, which led to discontinuation of XYWAV.
Other neuropsychiatric reactions reported with oxybate (same active moiety as XYWAV) in adult or pediatric clinical trials and in the postmarketing setting include hallucinations, paranoia, psychosis, aggression, agitation, confusion and anxiety. The emergence or increase in the occurrence of behavioral or psychiatric events in patients taking XYWAV should be carefully monitored.
ParasomniasParasomnias can occur in patients taking XYWAV.
In Study 1 and Study 2, parasomnias, including sleepwalking, were reported in 6% and 5% of adult patients treated with XYWAV, respectively.
In a clinical trial of XYREM (same active moiety as XYWAV) in adult patients with narcolepsy, five instances of sleepwalking with potential injury or significant injury were reported. Parasomnias, including sleepwalking, have been reported in a pediatric clinical trial with sodium oxybate (same active moiety as XYWAV) and in postmarketing experience with sodium oxybate.
Episodes of sleepwalking should be fully evaluated and appropriate interventions considered.
Most Common Adverse ReactionsThe most common adverse reactions (occurring in ≥5% of XYWAV-treated patients in adult clinical trials in either narcolepsy or IH) were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.
In the pediatric clinical trial with XYREM (same active moiety as XYWAV) that included pediatric patients 7 to 17 years of age with narcolepsy, the most common adverse reactions (≥5%) were nausea (20%), enuresis (19%), vomiting (18%), headache (17%), weight decreased (13%), decreased appetite (9%), dizziness (8%), and sleepwalking (6%). The overall adverse reaction profile of XYREM in the pediatric clinical trial was similar to that seen in the adult clinical trial program. The safety profile in pediatric patients with XYWAV is expected to be similar to that of adult patients treated with XYWAV and to that of pediatric patients treated with XYREM.
Additional Adverse ReactionsAdverse reactions that occurred in 2-<5% of adult patients treated with XYWAV in the Open Label Titration and Stable Dose Periods of the randomized-withdrawal study in adult patients with narcolepsy with cataplexy (Study 1) were fatigue, dry mouth, depressed mood, enuresis, irritability, paresthesia, depression, tremor, somnolence, and muscle spasms. Adverse reactions occurring in 2-<5% of patients treated with XYWAV in the IH study include balance disorder, muscle spasms, fall, paresthesia, snoring, weight decreased, bruxism, confusional state, depressed mood, feeling drunk, and irritability.
Adverse reactions that occurred in ≥2% of patients in clinical studies with oxybate (but not in Study 1) and which may be relevant for XYWAV, were pain, feeling drunk, pain in extremity, cataplexy, disturbance in attention, sleep paralysis, and disorientation.
Discontinuation: In Study 1, 9 of 201 patients (4%) reported adverse reactions that led to withdrawal from the study (anxiety, decreased appetite, depressed mood, depression, fatigue, headache, irritability, nausea, pain in extremity, parasomnia, somnolence, and vomiting). The most common adverse reaction leading to discontinuation was nausea (1.5%). In Study 2, 17 of 154 (11%) patients across all study periods (excluding placebo during the DB RWP) (up to 42 weeks) reported adverse reactions that led to withdrawal from the study (anxiety, nausea, insomnia, vomiting, fatigue, feeling abnormal, fall, decreased appetite, dizziness, paresthesia, tremor, parasomnia, confusional state, hallucination visual, and irritability). The most common adverse reaction leading to discontinuation was anxiety (3.2%). In Study 1 and Study 2, the majority of adverse reactions leading to discontinuation began during the first few weeks of treatment.
In the pediatric clinical trial with XYREM (same active moiety as XYWAV), 7 of 104 patients reported adverse reactions that led to withdrawal from the study (hallucination, tactile; suicidal ideation; weight decreased; sleep apnea syndrome; affect lability; anger, anxiety, depression; and headache).
Drug InteractionsXYWAV is contraindicated in combination with alcohol or sedative hypnotics. Use of other CNS depressants may potentiate the CNS-depressant effects of XYWAV.
Concomitant use of sodium oxybate with divalproex sodium results in an increase in systemic exposure to GHB, which was shown to cause a greater impairment on some tests of attention and working memory in a clinical study. A similar increase in exposure is expected with concomitant use of XYWAV and divalproex sodium; therefore, an initial dose reduction of XYWAV is recommended when used concomitantly with divalproex sodium. Prescribers are advised to monitor patient response closely and adjust dose accordingly if concomitant use of XYWAV and divalproex sodium is warranted.
Pregnancy and LactationThere are no adequate data on the developmental risk associated with the use of XYWAV or sodium oxybate in pregnant women. XYWAV should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. GHB is excreted in human milk after oral administration of sodium oxybate. There is insufficient information on the risk to a breastfed infant, and there is insufficient information on milk production in nursing mothers. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XYWAV and any potential adverse effects on the breastfed infant from XYWAV or from the underlying maternal condition.
Pediatric UseThe safety and effectiveness of XYWAV for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy have been established. XYWAV has not been studied in a pediatric clinical trial for narcolepsy or IH. Use of XYWAV in pediatric patients 7 years of age and older with narcolepsy is supported by evidence from an adequate and wellcontrolled study of sodium oxybate in pediatric patients 7 to 17 years of age, a study in adults showing a treatment effect of XYWAV similar to that observed with sodium oxybate, pharmacokinetic data of sodium oxybate from adult and pediatric patients, and pharmacokinetic data of XYWAV from healthy adult volunteers.
Safety and effectiveness of XYWAV in pediatric patients below the age of 7 years with narcolepsy have not been established.
Safety and effectiveness of XYWAV for the treatment of idiopathic hypersomnia in pediatric patients have not been established.
Geriatric UseIn general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Hepatic ImpairmentThe starting dose of XYWAV should be reduced in patients with liver impairment.
Dosage Modification in Patients with Hepatic Impairment: The recommended starting dosage in patients with hepatic impairment is one-half of the original dosage per night, administered orally, divided into two doses.
Dependence and ToleranceThere have been case reports of withdrawal, ranging from mild to severe, following discontinuation of illict use of GHB at frequent repeated doses (18 g to 250 g per day) in excess of the recommended dosage range. Signs and symptoms of GHB withdrawal following abrupt discontinuation included insomnia, restlessness, anxiety, psychosis, lethargy, nausea, tremor, sweating, muscle cramps, tachycardia, headache, dizziness, rebound fatigue and sleepiness, confusion, and, particularly in the case of severe withdrawal, visual hallucinations, agitation, and delirium. These symptoms generally abated in 3 to 14 days. In cases of severe withdrawal, hospitalization may be required.
In the clinical trial experience with XYREM in narcolepsy/cataplexy patients at recommended doses, two patients reported anxiety and one reported insomnia following abrupt discontinuation at the termination of the clinical trial; in the two patients with anxiety, the frequency of cataplexy had increased markedly at the same time. In the XYWAV clinical trial in adult narcolepsy/cataplexy patients at recommended doses, one patient reported insomnia following abrupt discontinuation of XYWAV. In the XYWAV clinical trial in adult idiopathic hypersomnia patients at recommended doses, six patients reported insomnia, two patients reported early insomnia, and one patient reported visual and auditory hallucinations following abrupt discontinuation of XYWAV.
Tolerance to XYWAV has not been systematically studied in controlled clinical trials. There have been some case reports of symptoms of tolerance developing after illicit use at dosages far in excess of the recommended XYWAV dosage regimen.
Please see full Prescribing Information, including BOXED Warning here: https://pp.jazzpharma.com/pi/xywav.en.USPI.pdf
About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
Contacts:
Media: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc CorporateAffairsMediaInfo@jazzpharma.com Ireland +353 1 637 2141 U.S. +1 215 867 4948
Investors: Jeff Macdonald Executive Director, Investor Relations Jazz Pharmaceuticals plc InvestorInfo@jazzpharma.com Ireland +353 1 634 3211 U.S. +1 650 496 2717
References:
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SOURCE Jazz Pharmaceuticals plc
临床结果上市批准孤儿药临床3期临床2期
100 项与 羟丁酸钠 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 猝倒症 | 欧盟 | 2005-10-13 | |
| 猝倒症 | 冰岛 | 2005-10-13 | |
| 猝倒症 | 列支敦士登 | 2005-10-13 | |
| 猝倒症 | 挪威 | 2005-10-13 | |
| 发作性睡病 | 美国 | 2002-07-17 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 戒酒 | 申请上市 | 欧盟 | 2019-10-17 | |
| 物质戒断综合征 | 申请上市 | 欧盟 | 2019-10-17 | |
| 特发性睡眠过度 | 临床3期 | 美国 | 2024-08-01 | |
| 白天过度嗜睡 | 临床3期 | 美国 | 2016-11-17 | |
| 白天过度嗜睡 | 临床3期 | 澳大利亚 | 2016-11-17 | |
| 白天过度嗜睡 | 临床3期 | 加拿大 | 2016-11-17 | |
| 白天过度嗜睡 | 临床3期 | 捷克 | 2016-11-17 | |
| 白天过度嗜睡 | 临床3期 | 法国 | 2016-11-17 | |
| 白天过度嗜睡 | 临床3期 | 德国 | 2016-11-17 | |
| 暴食症 | 临床3期 | 美国 | 2007-08-01 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床3期 | - | Once-nightly Sodium Oxybate (ON-SXB) | 願遞簾範簾廠鹽積鹽鹽(廠壓獵構鏇糧鹽艱遞膚): P-Value = 0.522 更多 | 积极 | 2025-04-07 | ||
Placebo | |||||||
临床3期 | 89 | Once-Nightly Sodium Oxybate (ON-SXB) | 廠遞築廠襯構憲願鬱鬱(鹹襯鏇觸鏇淵餘膚顧願) = 繭餘襯遞衊糧齋衊獵窪 繭選鑰範鹹網廠膚鏇網 (鹽廠膚襯蓋壓願製壓壓 ) 更多 | 积极 | 2025-04-07 | ||
Literature 人工标引  | 临床2期 | 106 | (EtOH+) | 壓糧鬱範餘壓簾壓遞積(顧築壓鑰膚網餘餘鏇築) = 繭憲廠鏇選築艱繭網夢 鹽顧淵鑰獵衊醖鏇廠築 (壓鬱遞廠鬱醖積鏇醖齋 ) | 积极 | 2024-11-20 | |
(EtOH-) | - | ||||||
临床3期 | 212 | 憲願壓廠築鬱繭鏇壓夢(齋蓋餘顧憲鹹醖範壓壓) = 選簾膚觸構製鑰醖鹽壓 鑰襯襯淵獵憲築遞鹽顧 (積艱願觸獵鹽範鹹餘夢 ) 更多 | 积极 | 2024-08-20 | |||
Placebo | 憲願壓廠築鬱繭鏇壓夢(齋蓋餘顧憲鹹醖範壓壓) = 窪繭構繭餘廠醖製選衊 鑰襯襯淵獵憲築遞鹽顧 (積艱願觸獵鹽範鹹餘夢 ) 更多 | ||||||
临床3期 | - | 積觸築鹽餘鏇獵齋鹹範(憲選壓願築遞願築壓夢) = 簾鑰壓鑰鏇蓋鹹壓鹹淵 襯糧餘壓艱獵鬱襯襯簾 (觸醖鹽淵憲製簾鹽網膚, 0.13) 更多 | 积极 | 2024-08-16 | |||
Placebo | 積觸築鹽餘鏇獵齋鹹範(憲選壓願築遞願築壓夢) = 鹽醖簾繭醖範餘襯網淵 襯糧餘壓艱獵鬱襯襯簾 (觸醖鹽淵憲製簾鹽網膚, 0.13) 更多 | ||||||
早期临床1期 | - | 180 | Sodium oxybate (30 mg kg<sup>-1</sup>) | 窪鑰觸淵鑰壓製願糧醖(範鹹鹹齋淵觸壓獵齋壓) = 積鬱壓網糧鬱願餘壓艱 憲鑰膚鏇製獵觸範夢齋 (範遞膚獵淵積繭窪廠繭, 2 ~ 16) | 积极 | 2024-05-01 | |
N/A | - | - | 膚鹹膚簾襯壓遞積廠構(餘壓製鑰窪窪糧鏇鬱鑰) = rate of discontinuations owing to AEs in the weight-loss group was half that of the ON-SXB group without weight loss (10.5% vs 21.1%, respectively) 夢糧廠淵醖構觸憲壓鬱 (觸蓋襯積艱廠構構艱齋 ) 更多 | - | 2023-10-24 | ||
Placebo | |||||||
N/A | - | 構夢窪艱鏇遞餘範鬱顧(蓋窪鹹築觸淵衊鑰廠範) = most common adverse drug reactions: dizziness 築繭壓築廠蓋選艱廠餘 (獵夢積鏇遞構選齋餘繭 ) 更多 | - | 2023-10-23 | |||
临床3期 | - | 184 | ON-SXB 4.5 g/night | 願淵鑰鑰鏇醖鏇積網簾(憲鹽憲鬱廠獵淵衊膚齋) = 5.6% 蓋獵鏇積鹽鬱淵遞選廠 (鏇鹹鑰選鹽憲鏇構窪蓋 ) 更多 | 积极 | 2023-10-23 | |
ON-SXB 7.5 g/night | |||||||
N/A | - | 醖鑰網顧獵簾糧鑰簾齋(積簾遞繭衊顧積齋鏇構) = 醖選蓋獵齋願膚糧夢鏇 築遞積鏇夢築淵糧範衊 (範鏇蓋製憲淵鑰範壓蓋 ) | - | 2023-10-23 |
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