Alixorexton

— 26 Abstracts Accepted Demonstrate Alkermes’ Commitment to Advancing Understanding and Treatment of Narcolepsy and Idiopathic Hypersomnia — — Detailed Positive Results from Vibrance-2 Phase 2 Study of Alixorexton, an Orexin 2 Receptor Agonist, in Patients With Narcolepsy Type 2 to be Shared in Oral Presentation — DUBLIN--(BUSINESS WIRE)-- Alkermes plc (Nasdaq: ALKS) today announced plans to present new data from its industry-leading portfolio of sleep medicine research at SLEEP 2026, the 40 th annual meeting of the Associated Professional Sleep Societies (APSS), taking place June 14-17, 2026 in Baltimore, MD. The company will present 26 abstracts, including posters featuring LUMRYZ ® (sodium oxybate) extended-release oral suspension, now part of Alkermes’ sleep portfolio following the acquisition of Avadel Pharmaceuticals plc in February 2026, and alixorexton, Alkermes’ novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). The company will present detailed results from the alixorexton Vibrance-2 study, the first large phase 2 clinical trial to demonstrate positive results with an OX2R agonist in patients with NT2 (n=93). The data will be shared in an oral presentation by Richard Bogan, M.D., FCCP, FAASM, Principal of Bogan Sleep Consultants, LLC and Associate Clinical Professor at the University of South Carolina School of Medicine. Primary and secondary efficacy and safety data, and exploratory patient-reported outcomes related to fatigue and cognition from the eight-week randomized, double-blind treatment period and optional five-week open-label extension, will be presented. Abstracts accepted for late-breaking poster presentations include: Baseline characteristics from the phase 3 REVITALYZ SM study evaluating the investigational use of LUMRYZ in adults with IH, for which positive topline results were recently announced; and Two posters detailing the study designs and methods for the Brilliance Studies, a phase 3 clinical trial program evaluating the safety and efficacy of alixorexton compared to placebo in patients with NT1 and NT2. “SLEEP 2026 is a defining moment for Alkermes as we strengthen our leadership in sleep medicine. Alkermes data being presented at SLEEP highlight the scope and scale of our scientific research in the field of sleep medicine and underscore our commitment to advancing care for people living with narcolepsy and idiopathic hypersomnia,” said Craig Hopkinson, M.D. (MBChB), Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. “We look forward to sharing detailed data from our alixorexton Vibrance-2 phase 2 study with clinicians, including findings related to fatigue and cognitive impairment in this population, and sharing compelling new data further characterizing the pro LUMRYZ. As we apply our neuroscience expertise to deepen our collective understanding of narcolepsy and idiopathic hypersomnia, our goal is to advance differentiated treatment approaches for patients impacted by these complex diseases.” Additional highlights to be presented at SLEEP 2026 include: Alixorexton clinical development Exploratory findings from the Vibrance-1 phase 2 study evaluating the impact of alixorexton compared to placebo on quality-of-life measures in patients with NT1. LUMRYZ real-world evidence Posters showing real-world experience and patient survey findings from REFRESH, a prospective multicenter, real-world study in patients with narcolepsy, including those who switched to LUMRYZ from a twice-nightly oxybate and those new to oxybate treatment or returning to oxybate treatment after discontinuing a twice-nightly oxybate. Research advancing understanding of hypersomnolence disorders Findings from the ASPIRE survey study evaluating the impact of cognitive impairment and fatigue on work productivity and health-related quality of life in people with NT1, NT2 and IH. Data from a claims database describing estimated prevalence of central disorders of hypersomnolence (CDoH), treatment patterns, and differences in treatment patterns across social determinants of health, including age, race, ethnicity and income level. Findings from a survey of people with idiopathic hypersomnia featuring data regarding patient experiences and preferences for oxybate treatment. The SLEEP 2026 abstracts are available on the SLEEP Meeting website: A full list of Alkermes’ presentations at SLEEP 2026 follows: Title Session Date and Time Oral Presentation Vibrance-2: A Randomized Phase 2 Study Evaluating Efficacy and Safety of the Orexin 2 Receptor Agonist Alixorexton in Patients with Narcolepsy Type 2 Session O-23 Wednesday, June 17 from 4:15-4:30 p.m. Poster Presentations Improvements in Quality of Life in Patients with Narcolepsy Type 1 Treated with the Orexin 2 Receptor Agonist Alixorexton Poster #373 Monday, June 15 from 10:00-10:45 a.m. Safety and Efficacy of the Orexin 2 Receptor Agonist Alixorexton in Patients With Narcolepsy Type 1: The Phase 2 Vibrance-1 Study Poster #385 Monday, June 15 from 10:00-10:45 a.m. Drug Class Utilization and Age-Related Trends in Narcolepsy and Idiopathic Hypersomnia: A Claims Database Analysis Poster #376 Monday, June 15 from 11:00-11:45 a.m. Polysomnographic Findings in Pediatric Patients With Narcolepsy Type 1 and Narcolepsy Type 2: A Retrospective Review Poster #307 Tuesday, June 16 from 10:00-10:45 a.m. Real-World Experience and Impact of Fatigue in Narcolepsy and Idiopathic Hypersomnia: Survey Results from the ASPIRE Study Poster #313 Tuesday, June 16 from 10:00-10:45 a.m. Impact of Economic Status Across Race and Ethnicity on Narcolepsy Treatment Access: A Claims Database Analysis Poster #317 Tuesday, June 16 from 10:00-10:45 a.m. Treatment Access for Narcolepsy Across Patient Demographic Characteristics: A Claims Database Analysis Poster #319 Tuesday, June 16 from 10:00-10:45 a.m. Alixorexton Improved Patient-Reported Disease Severity, Cognitive Functioning, and Fatigue in Patients With Narcolepsy Type 1 in the Vibrance-1 Study Poster #323 Tuesday, June 16 from 10:00-10:45 a.m. Improvement in Sleepiness With Once-Nightly Sodium Oxybate in People With Narcolepsy Type 1 and Narcolepsy Type 2: A Specialty Pharmacy Data Analysis Poster #327 Tuesday, June 16 from 10:00-10:45 a.m. Oxybate Treatment Patterns in Patients With Narcolepsy: Cohort Data From Mayo Clinic and Duke Health Poster #329 Tuesday, June 16 from 10:00-10:45 a.m. Sleepiness Improvement With Once-Nightly Sodium Oxybate in Patients With and Without Prior Twice-Nightly Oxybate Use: Specialty Pharmacy Data Analysis Poster #333 Tuesday, June 16 from 10:00-10:45 a.m. Oxybate Treatment Experience and Preferences of People With Idiopathic Hypersomnia Poster #341 Tuesday, June 16 from 10:00-10:45 a.m. Brilliance NT1: Study Design and Methods for 2 Phase 3, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating Alixorexton in Patients With Narcolepsy Type 1 Poster #531 Tuesday, June 16 from 10:00-10:45 a.m. Demographics and Disease Characteristics Among Pediatric Patients With Narcolepsy Poster #306 Tuesday, June 16 from 11:00-11:45 a.m. Demographics and Comorbidities of Patients With Narcolepsy: A Propensity Score–Matched Cohort Study Poster #308 Tuesday, June 16 from 11:00-11:45 a.m. Real-World Experience and Impact of Cognitive Impairment in Narcolepsy and Idiopathic Hypersomnia: Survey Results from the ASPIRE Study Poster #312 Tuesday, June 16 from 11:00-11:45 a.m. Relative Prevalence of Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia: A Claims Database Analysis Poster #314 Tuesday, June 16 from 11:00-11:45 a.m. Impact of Sex and Race on Treatment of Narcolepsy: A Claims Database Analysis Poster #318 Tuesday, June 16 from 11:00-11:45 a.m. Once-Nightly Sodium Oxybate Improves Symptoms in People With Narcolepsy: Final Results From the Real-World REFRESH Study Poster #328 Tuesday, June 16 from 11:00-11:45 a.m. Nighttime Symptom Experience and Treatment Challenges: Perspectives From People With Narcolepsy Poster #340 Tuesday, June 16 from 11:00-11:45 a.m. Real-World Experience of Once-Nightly Sodium Oxybate Treatment in People With Narcolepsy: Final Results From REFRESH Poster #342 Tuesday, June 16 from 11:00-11:45 a.m. REVITALYZ: A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Withdrawal Trial of Extended-Release Sodium Oxybate for Idiopathic Hypersomnia Poster #530 Tuesday, June 16 from 11:00-11:45 a.m. Brilliance NT2: Study Design and Methods for a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Alixorexton in Patients With Narcolepsy Type 2 Poster #532 Tuesday, June 16 from 11:00-11:45 a.m. Demographic and Clinical Characteristics of People Receiving Once-Nightly Sodium Oxybate Treatment: A Specialty Pharmacy Data Analysis Poster #345 Wednesday, June 17 from 10:00-10:45 a.m. Risk Evaluation and Mitigation Strategies: From Burden to Benefit Poster #190 Wednesday, June 17 from 11:00-11:45 a.m. About LUMRYZ ® (sodium oxybate) for extended-release oral suspension LUMRYZ (sodium oxybate) for extended-release oral suspension is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. IMPORTANT SAFETY INFORMATION WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE Central Nervous System Depression LUMRYZ ® (sodium oxybate) is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with LUMRYZ at recommended doses. Many patients who received LUMRYZ during clinical trials in narcolepsy were receiving CNS stimulants. Abuse and Misuse LUMRYZ (sodium oxybate) is the sodium salt of 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, decreased consciousness, coma, and death. Because of the risks of CNS depression and abuse and misuse, LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the LUMRYZ REMS. CONTRAINDICATIONS LUMRYZ is contraindicated for use in: combination with sedative hypnotics or alcohol patients with succinic semialdehyde dehydrogenase deficiency WARNINGS AND PRECAUTIONS Central Nervous System Depression The concurrent use of LUMRYZ with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating antiepileptic 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 LUMRYZ is required, dose reduction or discontinuation of one or more CNS depressants (including LUMRYZ) should be considered. In addition, if short-term use of an opioid (eg, post- or perioperative) is required, interruption of treatment with LUMRYZ should be considered. After first initiating treatment and until certain that LUMRYZ does not affect them adversely (eg, impair judgment, thinking, or motor skills), caution patients against engaging in hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes. Also caution patients against engaging in these hazardous activities for at least six (6) hours after taking LUMRYZ. Patients should be queried about CNS depression-related events upon initiation of LUMRYZ therapy and periodically thereafter. Abuse and Misuse LUMRYZ is a Schedule III controlled substance. The active ingredient of LUMRYZ, sodium oxybate, is the sodium salt of 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. LUMRYZ REMS LUMRYZ is available only through a restricted distribution program called the LUMRYZ REMS because of the risks of central nervous system depression and abuse and misuse. Notable requirements of the LUMRYZ REMS include the following: Healthcare providers who prescribe LUMRYZ are specially certified. LUMRYZ will be dispensed only by pharmacies that are specially certified. LUMRYZ will be dispensed and shipped only to patients who are enrolled in the LUMRYZ REMS with documentation of safe use conditions. Further information is available at or by calling 1-877-453-1029. Respiratory Depression and Sleep-Disordered Breathing LUMRYZ may impair respiratory drive, especially in patients with compromised respiratory function. In overdoses of oxybate with illicit use of GHB, life-threatening respiratory depression has been reported. Increased apnea and reduced oxygenation may occur with LUMRYZ administration. A significant increase in the number of central apneas and clinically significant oxygen desaturation may occur in patients with obstructive sleep apnea treated with LUMRYZ. 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 Depression, and suicidal ideation and behavior, can occur in patients treated with LUMRYZ. In an adult clinical trial in patients with narcolepsy (n=212), there were no suicide attempts, but one patient with a history of depression and anxiety developed suicidal ideation in the LUMRYZ-treated group. In a clinical trial in pediatric narcolepsy patients administered immediate-release sodium oxybate, one patient experienced suicidal ideation and two patients reported depression. The emergence of depression in patients treated with LUMRYZ requires careful and immediate evaluation. Patients with a previous history of a depressive illness and/or a suicide attempt should be monitored carefully for the emergence of depressive symptoms while taking LUMRYZ. Other Behavioral or Psychiatric Adverse Reactions Other behavioral and psychiatric adverse reactions can occur in patients taking LUMRYZ. During adult clinical trials in patients with narcolepsy administered LUMRYZ, 2% of 107 patients treated with LUMRYZ experienced a confusional state. No patients treated with LUMRYZ discontinued treatment because of confusion. Anxiety occurred in 7.5% of 107 patients treated with LUMRYZ in the adult trial in patients with narcolepsy. Other psychiatric reactions reported in adult clinical trials in patients with narcolepsy administered LUMRYZ included irritability, emotional disorder, panic attack, agitation, delirium, and obsessive thoughts. Other neuropsychiatric reactions reported in adult clinical trials in patients with narcolepsy administered immediate-release sodium oxybate and in the postmarketing setting for immediate-release sodium oxybate include hallucinations, paranoia, psychosis, aggression, and agitation. In a clinical trial in pediatric patients administered immediate-release sodium oxybate, neuropsychiatric reactions including acute psychosis, confusion, and anxiety were reported. The emergence or increase in the occurrence of behavioral or psychiatric events in patients taking LUMRYZ should be carefully monitored. Parasomnias Parasomnias can occur in patients taking LUMRYZ. Sleepwalking, defined as confused behavior occurring at night and at times associated with wandering, was reported in 3% of 107 adult patients with narcolepsy treated with LUMRYZ. No patients treated with LUMRYZ discontinued due to sleepwalking. Episodes of sleepwalking should be fully evaluated and appropriate interventions considered. Use in Patients Sensitive to High Sodium Intake LUMRYZ has a high sodium content. In patients sensitive to sodium intake (eg, those with heart failure, hypertension, or renal impairment), consider the amount of daily sodium intake in each dose of LUMRYZ. MOST COMMON ADVERSE REACTIONS Most common adverse reactions (incidence ≥5% and greater than placebo) reported for any dose of LUMRYZ in a trial of adults with narcolepsy were nausea, dizziness, enuresis, headache, and vomiting. Similarly, in a trial of pediatric narcolepsy patients receiving immediate-release sodium oxybate, the most commonly observed adverse reactions (incidence ≥5%) were nausea, enuresis, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking. ADDITIONAL ADVERSE REACTIONS Additional adverse reactions that occurred in ≥2% of adult patients with narcolepsy treated with LUMRYZ and were more frequent in the LUMRYZ treatment group than with placebo were vomiting, nausea, decreased weight, decreased appetite, dizziness, somnolence, headache, enuresis, anxiety, and somnambulism. DRUG INTERACTIONS LUMRYZ is contraindicated for use in combination with alcohol or sedative hypnotics. Use of other CNS depressants may potentiate the CNS-depressant effects of LUMRYZ. PREGNANCY AND LACTATION There are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women. LUMRYZ 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 LUMRYZ and any potential adverse effects on the breastfed infant from LUMRYZ or from the underlying maternal condition. PEDIATRIC USE LUMRYZ has not been studied in a pediatric clinical trial for narcolepsy. The safety and effectiveness of LUMRYZ in the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy is supported by evidence from a double-blind, placebo-controlled, randomized-withdrawal study of immediate-release sodium oxybate. Safety and effectiveness of LUMRYZ in pediatric patients below the age of 7 years have not been established. GERIATRIC USE 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 LUMRYZ should not be initiated in patients with hepatic impairment because appropriate dosage adjustments for initiation cannot be made with the available dosage strengths. Patients with hepatic impairment who have been titrated to a maintenance dosage of another oxybate product can be switched to LUMRYZ if the appropriate dosage strength is available. 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 three (3) to fourteen (14) days. In cases of severe withdrawal, hospitalization may be required. The discontinuation effects of LUMRYZ have not been systematically evaluated in controlled clinical trials. Tolerance to LUMRYZ 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 LUMRYZ dosage regimen. Please see full Prescribing Information , including BOXED Warning. About Alixorexton Alixorexton (formerly referred to as ALKS 2680) is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain. 1 Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease. 2 Once-daily oral administration of alixorexton was previously evaluated in a phase 1 study in healthy volunteers and patients with NT1, NT2 and IH, and in Vibrance-1 and Vibrance-2, phase 2 studies in patients with NT1 and NT2, respectively. Alixorexton is currently being evaluated in the phase 3 Brilliance Studies in patients with NT1 and NT2, and in the phase 2 Vibrance-3 study in patients with IH. Alixorexton has received Breakthrough Therapy designation for the treatment of NT1 from the U.S. Food and Drug Administration (FDA). About Alkermes plc Alkermes plc (Nasdaq: ALKS), a mid-cap growth and value equity, is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy. Alkermes’ pipeline includes late-stage clinical candidates in development for narcolepsy and idiopathic hypersomnia, and orexin 2 receptor agonists in early clinical development for other neurological disorders, including attention-deficit hyperactivity disorder (ADHD) and fatigue associated with multiple sclerosis and Parkinson’s disease. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes’ website at . Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of alixorexton and LUMRYZ. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Contacts Alkermes Contacts: For Investors: Sandy Coombs, +1 781 609 6377 For Media: Gretchen Murphy, +1 781 609 6419 Read full story here