This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.

开始日期2025-04-21

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT06701396

/ Recruiting临床3期

A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Subjects with Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant

This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.

开始日期2024-10-08

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT05922995

/ Not yet recruiting早期临床1期IIT

A Single Center, Open Label Prospective Observational Pilot Study to Evaluate the Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)

To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to baseline on events of dream enactment on patients with REM Behavior Disorder, as measured by a daily log.
To assess the effects of 20 mg tasimelteon compared to baseline on insomnia= symptoms, as measured by validated questionnaires (Insomnia Severity Index [ISI], Pittsburgh Sleep Quality Inventory [PSQI], Epworth Sleepiness Scale [ESS], Clinical Global Impression of Change Scale (CGI-C), Patient Global Impression of Change Scale (PGI-C)) as well as rest/activity pattern from actigraphy.
To assess the effects of 20 mg tasimelteon on patients who have a reduced or aberrant melatonin secretion compared to normal secretion by measuring salivary DLMO at baseline and correlating with the degree of change in RBD symptoms by end of the study.
To assess for any role a patient's unique genome may play in their response to tasimelteon; obtained via whole genome sequencing.
To assess the safety and tolerability of a daily single oral dose of 20 mg tasimelteon.

开始日期2023-09-30

申办/合作机构

The Brigham & Women's Hospital, Inc.

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100 项与他司美琼相关的专利（医药）

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项与他司美琼相关的文献（医药）

2024-11-01·SCIENCE OF THE TOTAL ENVIRONMENT

Effects of low-molecular-weight organic acids on the transport of polystyrene nanoplastics: An insight at the structure of organic acids

Article

作者: Wei, Xuan ; Gong, Yi ; Lu, Taotao ; Chen, Feiyu ; Chen, Dong

Plastic nanoparticles are extensively used in various products, leading to inevitable pollution in soil. Understanding their transport in soils where various organic substances exist is crucial. This study examined the impact of low-molecular-weight organic acids (LMWOAs) on the transport of polystyrene nanoplastics (PS-NPs) through saturated quartz sand. The experiments involved three dibasic acids-malonic acid (MA₁), malic acid (MA₂) and tartaric acid (TA) - and four monobasic acids- formic acid (FA), acetic acid (AA), propanoic acid (PA) and glycolic acid (GA) -under different pH levels (4.0, 5.5, 7.0) and in the presence of cations (Na⁺, Ca²⁺). The results demonstrated that in the presence of Na⁺, dibasic acids significantly enhanced PS-NPs transport, with TA being the most effective, followed by MA₂ and MA₁. This enhancement is attributed to the adsorption of LMWOAs onto the nanoparticles and sand, creating a more negative ζ-potential, which increases the electrostatic repulsion and decreases the PS-NPs deposition, thereby facilitating the transport. Applying the Derjaguin-Landau-Verwey-Overbeek theory, higher pH levels increased the energy barrier and secondary energy minimum, decreasing PS-NPs deposition. Moreover, dibasic acids significantly enhanced the hydrophilicity of PS-NPs. Conversely, monobasic acids, except for GA, slightly reduced the hydrophilicity of PS-NPs, as indicated by a small increase in the water contact angle, hereby minimally affecting PS-NPs transport. As for GA, although it is a monobasic acid, the additional -OH group in its molecular structure promoted PS-NPs transport, similar to dibasic acids. For example, GA also significantly enhanced the hydrophilicity of PS-NPs. In the presence of Ca²⁺, the enhancement of PS-NPs transport by LMWOAs was comparable to that with Na⁺, primarily due to the complex-forming and bridging effects of Ca²⁺ with the organic acids and PS-NPs. These findings provide important insights into predicting and analyzing the transport behaviors of PS-NPs.

2024-10-01·iScience

Few-shot meta-learning applied to whole brain activity maps improves systems neuropharmacology and drug discovery

Article

作者: Wang, Xin ; Haggarty, Stephen J. ; Ding, Yanyun ; Zhang, Wenchong ; Liu, Zhen ; Li, Honglin ; Zhang, Jin ; Haggarty, Stephen J ; Zeng, Shangzhi ; Cao, Yi ; Cheng, Shuk Han ; Shi, Peng ; Luo, Xuan

In this study, we present an approach to neuropharmacological research by integrating few-shot meta-learning algorithms with brain activity mapping (BAMing) to enhance the discovery of central nervous system (CNS) therapeutics. By utilizing patterns from previously validated CNS drugs, our approach facilitates the rapid identification and prediction of potential drug candidates from limited datasets, thereby accelerating the drug discovery process. The application of few-shot meta-learning algorithms allows us to adeptly navigate the challenges of limited sample sizes prevalent in neuropharmacology. The study reveals that our meta-learning-based convolutional neural network (Meta-CNN) models demonstrate enhanced stability and improved prediction accuracy over traditional machine-learning methods. Moreover, our BAM library proves instrumental in classifying CNS drugs and aiding in pharmaceutical repurposing and repositioning. Overall, this research not only demonstrates the effectiveness in overcoming data limitations but also highlights the significant potential of combining BAM with advanced meta-learning techniques in CNS drug discovery.

2024-08-01·JOURNAL OF PINEAL RESEARCH

Relationship Between Melatonin Receptor Agonists and Parkinson's Disease

Article

作者: Masuda, Rikuto ; Yoshimura, Tomoaki ; Noguchi, Yoshihiro ; Aizawa, Haruka

Abstract:

Parkinson's disease affects millions of people worldwide, and without significant progress in disease prevention and treatment, its incidence and prevalence could increase by more than 30% by 2030. Researchers have focused on targeting sleep and the circadian system as a novel treatment strategy for Parkinson's disease. This study investigated the association between melatonin receptor agonists and Parkinson's disease, using the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS). The target drugs were melatonin receptor agonists including ramelteon, tasimelteon, and agomelatine. Parkinson's disease cases were defined according to the Medical Dictionary for Regulatory Activities (MedDRA) 25.0; Standardized MedDRA Query (SMQ) using both the “narrow” and “broad” preferred terms (PTs) associated with Parkinson's disease. The association between melatonin receptor agonists (ramelteon, tasimelteon, and agomelatine) and Parkinson's disease was evaluated by the reporting odds ratio. Upon analyzing the data from all patients registered in the FAERS, ramelteon (ROR: 0.66, 95% confidence interval [95% CI]: 0.51–0.84) and tasimelteon (ROR: 0.49, 95% CI: 0.38–0.62) showed negative correlations with Parkinson's disease. Conversely, only agomelatine was positively correlated with Parkinson's disease (ROR: 2.63, 95% CI: 2.04–3.40). These results suggest that among the melatonin receptor agonists, ramelteon and tasimelteon are negatively correlated with Parkinson's disease. In contrast, agomelatine was shown to be positively correlated with Parkinson's disease. These results should be used in research to develop drugs for the treatment of Parkinson's disease, fully considering the limitations of the spontaneous reporting system.

项与他司美琼相关的新闻（医药）

2025-05-07

·PRNewswire

Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results

Fanapt® Q1 2025 total prescriptions (TRx) increased 14% compared to Q1 2024 Fanapt® Q1 2025 new to brand prescriptions (NBRx) increased nearly threefold compared to Q1 2024 Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026 Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of December 30, 2025 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025 WASHINGTON, May 7, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2025. Continue Reading Fanapt® TRx and NBRx "Vanda has entered a new growth phase with multiple commercialized products and a rich innovative pipeline. Fanapt commercial growth has accelerated, reaching multi-year highs, with weekly prescriptions surpassing 2,000 at the end of April as an increasing number of prescribers are adding Fanapt to their therapeutic armamentarium," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Our recent new drug application filings for tradipitant and Bysanti are a testament to our productive research and development pipeline. The addition of imsidolimab alongside Ponvory establishes an anti-inflammatory franchise that we believe has significant growth potential. These accomplishments have been possible because of our talented employees, who for the first time surpassed 400 in number, a 22-year high." Financial Highlights Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $50.0 million in the first quarter of 2025, a 5% increase compared to $47.5 million in the first quarter of 2024. Fanapt® net product sales were $23.5 million in the first quarter of 2025, a 14% increase compared to $20.6 million in the first quarter of 2024. HETLIOZ® net product sales were $20.9 million in the first quarter of 2025, a 4% increase compared to $20.1 million in the first quarter of 2024. PONVORY® net product sales were $5.6 million in the first quarter of 2025, a decrease of 18% compared to $6.8 million in the first quarter of 2024. Net loss was $29.5 million in the first quarter of 2025 compared to net loss of $4.1 million in the first quarter of 2024. The net loss in the first quarter of 2025 reflects expenses associated with the payment of $15.0 million related to the exclusive, global license agreement with AnaptysBio, Inc. (Anaptys) for the development and commercialization of imsidolimab and increased commercial activities. Cash, cash equivalents and marketable securities (Cash) was $340.9 million as of March 31, 2025, representing a decrease to Cash of $33.7 million compared to December 31, 2024. The decrease to Cash reflects the payment of $15.0 million during the first quarter of 2025 related to the exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab. Key Operational Highlights – Commercial Fanapt® (iloperidone) Fanapt® was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of Fanapt® in this indication in the third quarter of 2024. In the first quarter of 2025, as compared to the first quarter of 2024, total prescriptions (TRx)1 increased by approximately 14% and Fanapt® net product sales increased by 14%. Additionally, new patient starts, as reflected by new to brand prescriptions (NBRx),1 increased by nearly threefold in the same period. Fanapt® total prescriptions (TRx) for the week of April 25, 2025 reached the milestone of 2,000, making Fanapt® one of the fastest growing atypical antipsychotics.1 Vanda has also announced an expansion of its psychiatry sales force to approximately 300 representatives. HETLIOZ® (tasimelteon) Through the first quarter of 2025, HETLIOZ® continues to retain the largest portion of market share despite generic competition for over two years.2 PONVORY® (ponesimod) Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024. In April 2025, new patient prescriptions reached a new record high since the initiation of Vanda's commercial launch. Vanda has re-enforced the PONVORY® sales leadership team and announced an expansion of its PONVORY® sales force to approximately 40 representatives. Key Operational Highlights – Regulatory & Clinical Development Key Regulatory Milestones Tradipitant New Drug Application (NDA) for motion sickness accepted for filing by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025. Fanapt® Marketing Authorization Application (MAA) for bipolar I disorder and schizophrenia submitted to the European Medicines Agency (EMA) in Q4 2024. HETLIOZ® MAA in Smith-Magenis syndrome (SMS) submitted to the EMA in Q4 2024. Bysanti™ NDA for bipolar I disorder and schizophrenia accepted for filing by the FDA with a PDUFA target action date of February 21, 2026. Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) expected to be submitted to the FDA in 2025. Key Clinical Highlights Fanapt® (iloperidone) Schizophrenia: A Phase III program for the long acting injectable (LAI) formulation of Fanapt® in the treatment of schizophrenia in relapse prevention is ongoing. Hypertension: Vanda initiated a study of the Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension and plans to begin enrolling patients soon. Bysanti™ (milsaperidone) The NDA for Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia was accepted for filing by the FDA with a PDUFA target action date of February 21, 2026. Exclusivity for Bysanti™, including pending patent applications, could extend into the 2040s. Bysanti™ is a new chemical entity, which was initially identified as an active metabolite of iloperidone. Vanda discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone. In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies. The results of these clinical studies will be presented in late May, at the 2025 American Society of Clinical Psychopharmacology annual meeting in Scottsdale, Arizona. The Bysanti™ Phase III clinical study for use as a once-daily adjunctive treatment for major depressive disorder (MDD) is ongoing. Results are expected in 2026. HETLIOZ® (tasimelteon) HETLIOZ® clinical programs in pediatric insomnia and delayed sleep phase disorder (DSPD) are ongoing. Vanda's MAA for HETLIOZ® and HETLIOZ LQ® for SMS is pending with the EMA. PONVORY® (ponesimod) Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024. Tradipitant The NDA for tradipitant for the treatment of motion sickness was accepted for filing by the FDA with a PDUFA target action date of December 30, 2025. In the fourth quarter of 2024, Vanda initiated a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy (semaglutide). Results are expected in the third quarter of 2025. Imsidolimab In February 2025, Vanda announced it entered into an exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab (IL-36R antagonist mAb). A BLA for GPP is expected to be submitted to the FDA in 2025. Early-Stage Program Highlights VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda expects to initiate the Phase III program in 2025. The IND application for VCA-894A in the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, was accepted by the FDA in 2024. Previously in 2023, VCA-894A was granted Orphan Drug Designation for the same indication. The Phase I clinical study for VCA-894A expects to enroll the patient by mid-2025. GAAP Financial Results Net loss was $29.5 million in the first quarter of 2025 compared to net loss of $4.1 million in the first quarter of 2024. Diluted net loss per share was $0.50 in the first quarter of 2025 compared to diluted net loss per share of $0.07 in the first quarter of 2024. 2025 Financial Guidance Vanda is reiterating its 2025 total revenues guidance and updating its 2025 financial guidance to include year-end 2025 Cash. Vanda expects to achieve the following financial objectives in 2025: Conference Call Vanda has scheduled a conference call for today, Wednesday, May 7, 2025, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2025 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 9941754. A replay of the call will be available on Wednesday, May 7, 2025, beginning at 8:30 PM ET and will be accessible until Wednesday, May 14, 2025 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 9941754. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data Based on blended data analysis About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2025 Financial Guidance" above and statements regarding the growth potential of Vanda's anti-inflammatory franchise; Vanda's plans for pursuit of FDA approval of Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia, tradipitant for the treatment of motion sickness, and imsidolimab for the treatment of GPP, and the related timelines; Vanda's plans for pursuit of EMA approval of Fanapt® for the treatment of bipolar I disorder and schizophrenia and HETLIOZ® and HETLIOZ LQ® for the treatment of SMS; Vanda's clinical development plans and expected timelines for Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension, Bysanti™ for the treatment of MDD, VQW-765 for the treatment of acute performance anxiety in social situations, and VCA-894A for the treatment of CMT2S; the expected timing of the results of the tradipitant clinical trial for the prevention of vomiting induced by Wegovy; and the potential to extend patent exclusivity for Bysanti™ into the 2040s are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to continue to grow its business; Vanda's ability to obtain regulatory approval and execute a successful commercial launch of imsidolimab, and increase PONVORY® revenue; the FDA's ability to complete its reviews of, and reach decisions with respect to, the NDAs for Bysanti™ and tradipitant by their respective PDUFA target action dates; Vanda's ability to complete and submit the BLA for imsidolimab in 2025; Vanda's ability to obtain EMA approval of the MAAs for Fanapt® and HETLIOZ® and HETLIOZ LQ®, Vanda's ability to begin enrolling patients in the Fanapt® LAI study within the specified timeframe; Vanda's ability to complete the Phase III clinical study for Bysanti™ for MDD and receive results in 2026; Vanda's ability to complete the clinical trial of tradipitant for the prevention of vomiting induced by Wegovy and receive results in the third quarter of 2025; Vanda's ability to initiate the Phase III program for VQW-765 in 2025; Vanda's ability to enroll the CMT2S patient in the Phase I clinical study for VCA-894A by mid-2025; and Vanda's ability to satisfy the conditions necessary to extend Bysanti™'s patent exclusivity into the 2040s. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 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临床1期引进/卖出上市批准临床3期申请上市

2025-04-18

·生物制药小编

硬刚派Biotech，把FDA再告上法庭

Vanda Pharmaceuticals再次与FDA诉诸了法庭。近日，Vanda在美国德克萨斯州南区地方法院对FDA再次提起了上诉，Vanda指控其侵犯了《第一修正案》赋予公司向医生提供其已获批药物相关信息的权利。这次的诉讼是为了拓展已上市药物Hetlioz标签外的用途—治疗时差障碍，这是此前已被FDA拒绝批准的适应症。根据诉状，Vanda指出，其在推广Hetlioz与该适应症的相关信息时遭到了FDA的限制，公司认为，FDA的限制阻止了公司与医生分享Hetlioz的最新信息，并且公司认为提供的临床数据足以支持Hetlioz用于治疗该适应症。现在，公司要求法院判决其提供Hetlioz标签外用途的相关信息都是真实的。与FDA长期紧张的关系长期以来，Vanda和FDA的关系都非常紧张，因为监管分歧，公司起诉FDA是常有的事。早在2018年，Hetlioz治疗时差障碍的新药补充上市申请遭到FDA的拒绝批准时，Vanda就选择了与FDA进行了当庭对峙，不过，仍然没能更改FDA的决定，至今该适应症仍未能获得批准。一般而言，药企在新药上市申请遭到监管拒绝后，都是老老实实补充相关数据，以符合FDA的监管要求，但大多数情况下，这家公司在遇到与FDA意见分歧的时候都选择了硬刚。除了Hetlioz之外，因为另一款药物tradipitant（神经激肽-1受体拮抗剂）临床试验上的分歧，Vanda也多次选择了与FDA当庭对峙。在2018年，FDA部分暂停了其胃轻瘫药物tradipitant的两项临床研究后，Vanda就将FDA告上法庭，原因是FDA要求Vanda提供其动物临床前毒理数据，而Vanda认为动物研究并非必要的。之后tradipitant提交新药上市申请的时候，Vanda还是坚持己见，选择了基于微生理系统的非动物临床前毒理学数据。不意外的，去年3月，FDA断然向公司发出了CRL，tradipitant治疗胃轻瘫的新药上市申请遭到FDA拒绝批准，而Vanda事后也对FDA这一批准决定再度进行了指责。相关阅读：药物被拒，反而指责FDA违宪流年不利的HetliozHetlioz是一款褪黑素受体激动剂，是Hetlioz第一款上市药物，2014年获得FDA批准，用以治疗非24小时睡眠-觉醒周期障碍，2020年又获FDA批准拓展新适应症—史密斯-马吉利综合征夜间睡眠障碍。此前，Hetlioz一直Vanda的一大营收支柱，贡献了公司超一半的收入，但自2023年开始，Hetlioz销售业绩开始出现显著下滑，同比2022年（1.597亿美元）下降了37%。2024年，Hetlioz也是各种不顺，3月的时候，其治疗失眠适应症的新药补充上市申请遭到了FDA的拒绝，在4月，Hetlioz还输掉了与仿制药厂家的诉讼。2024年，Hetlioz的销售额仍在下滑，为7667.5万美元。除了Hetlioz之外，Vanda还有两款上市产品——Fanapt和Ponvry，Fanapt于2009年首次获得FDA批准，用于急性成人精神分裂症，去年在4月成功获批了I型双相情感障碍的新适应症，Fanapt已经成为公司销售额第一的的产品，2024年销售额为9429.7万美元，同比增长4%。另一方面，虽然与FDA关系很僵，但是公司正在为其多款管线准备提交上市申请。今年3月，公司已向FDA提交其抗精神病药物Bysanti™(milsaperidone)用于治疗双相I型障碍和精神分裂症的新药上市申请（NDA），另外，公司计划在今年为其IL-36R单抗Imsidolimab提交BLA，用于治疗广泛性脓疱性银屑病。参考出处https://www.biospace.com/fda/vanda-sues-fda-again-this-time-over-off-label-use-of-hetlioz-for-jet-laghttps://vandapharmaceuticalsinc.gcs-web.com/node/16266/pdf

专利侵权

2025-04-14

·BioSpace

Vanda Sues FDA Again, This Time Over Off-Label Use of Hetlioz for Jet Lag

iStock, photoguns Vanda is criticizing the FDA’s restrictions on information companies can provide regarding off-label use of approved medicines. Despite suffering a series of rebuffs from the FDA, Vanda Pharmaceuticals is continuing to fight for sedative Hetlioz, suing the regulator last week to use the drug off-label for jet lag. In the complaint, filed April 9 with the U.S. District Court for the Southern District of Texas, Vanda slammed the regulator’s “restrictive regulatory regime,” and alleged a violation of the company’s First Amendment right to provide doctors with relevant information about its drugs, as per reporting from Fierce Pharma . Hetlioz is a sedative that was first approved in 2014 for non-24-hour sleep-wake disorder and was later granted a label expansion to cover sleep disorders for the rare disease Smith-Magenis syndrome. At issue is Vanda’s desire to promote Hetlioz in off-label uses. Doctors can legally prescribe approved drugs off label for uses that have yet to be cleared by the FDA, but the agency limits the information that companies can share about unapproved uses. As per a recent guidance document , drug sponsors “should provide and appropriately present all information necessary” to allow healthcare providers to better assess the benefits and risks of the unapproved uses. Companies should also be “truthful and non-misleading,” according to the FDA guidance. Their communications to doctors should emphasize that the product has not yet been approved by the FDA for the use and include details regarding known contraindications and safety risks. Vanda took issue with these restrictions, noting in its press release that they “prevent pharmaceutical manufacturers from sharing their new discoveries with doctors” for fear of being misleading, Fierce reported. The biotech added that while they have a “credible fear” of being sanctioned for sharing Hetlioz data to doctors, it’s the patients who “ultimately suffer” from the FDA’s limitations. Also in the court complaint, Vanda provided detailed clinical information about Hetlioz’s efficacy and safety in patients with jet lag, for which the drug is not approved. Vanda insists that the data support the drug’s use in this indication. The biotech is asking the court to declare its information about off-label Hetlioz use to be truthful. Vanda’s latest lawsuit puts even more pressure on an already-strained relationship with the FDA. In July 2019, the regulator rejected Vanda’s bid for approval of Hetlioz in jetlag, a decision which the biotech appealed. Vanda asked for a hearing on the verdict in July 2022, but after months of not hearing back, the biotech sued the regulator for not being able to stick to its mandated timeline. The FDA last year also rejected Vanda’s application for the NK-1R antagonist tradipitant for gastroparesis, a move that the biotech again contested. In September 2024, Vanda argued that the regulator’s verdict “generally disregarded the evidence provided.” The biotech again blasted the FDA’s timeline—the decision on tradipitant was delayed by more than 185 days, which violates the Federal Drug and Cosmetic Act’s 180-day deadline, Vanda argued. In January, the biotech escalated the matter to then-FDA Commissioner Robert Califf. In a letter, Vanda called attention to the “culture of obfuscation and closemindedness” at the agency, which it faults for the lack of transparency regarding tradipitant’s rejection. A few days after the letter, the FDA finally provided Vanda with a justification for the rejection and gave the company the chance to request a hearing.

上市批准专利侵权

100 项与他司美琼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09388	他司美琼	N05CH03	DB09071

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
入睡和睡眠障碍	美国	Vanda Pharmaceuticals, Inc.	2020-12-01
睡眠-觉醒节律障碍	美国	Vanda Pharmaceuticals, Inc.	2014-01-31

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
飞行时差反应综合征	申请上市	美国	Vanda Pharmaceuticals, Inc.	-
Smith-Magenis综合征	申请上市	欧盟	Vanda Pharmaceuticals, Inc.	-
自闭症谱系障碍	临床3期	美国	Vanda Pharmaceuticals, Inc.	2021-07-28
睡眠剥夺	临床3期	美国	Vanda Pharmaceuticals, Inc.	2015-09-01
重度抑郁症	临床3期	美国	Vanda Pharmaceuticals, Inc.	2011-09-01
日夜节律睡眠障碍	临床3期	美国	Vanda Pharmaceuticals, Inc.	2010-08-01
日夜节律睡眠障碍	临床3期	德国	Vanda Pharmaceuticals, Inc.	2010-08-01
普遍的儿童发育障碍	临床2期	美国	Vanda Pharmaceuticals, Inc.	2021-09-16
REM睡眠行为障碍	临床1期	美国	Vanda Pharmaceuticals, Inc.	2023-09-30
嗜睡	临床1期	加拿大	Vanda Pharmaceuticals, Inc.	2012-04-01

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临床结果

适应症

分期

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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


NCT03373201 (JET8 Study, CTgov)	临床3期	飞行时差反应综合征	320	Placebo (Placebo)	廠選繭獵餘鬱蓋鹹窪醖(衊選餘餘窪壓鹹積齋觸) = 醖積窪網積鹹鹽蓋觸糧鹹願襯繭襯蓋製範窪淵 (憲構範簾鹹範鹽醖壓廠, 80.67) 更多	-	2023-09-15
				Tasimelteon (Tasimelteon)	廠選繭獵餘鬱蓋鹹窪醖(衊選餘餘窪壓鹹積齋觸) = 鹽襯範鬱網積憲齋齋襯鹹願襯繭襯蓋製範窪淵 (憲構範簾鹹範鹽醖壓廠, 69.69) 更多
NCT03291041 (JET, Pubmed) 人工标引	临床2期	飞行时差反应综合征	25	tasimelteon	網膚製範鹹構願繭襯憲(選憲顧廠選鹽願製選製): difference = 131	积极	2022-09-15
				Placebo
NCT03291041 (JET, CTgov)	临床2期	飞行时差反应综合征	25	Tasimelteon (Tasimelteon)	鑰鹹衊鹽鬱淵鑰壓窪鑰(蓋夢製醖餘壓糧夢壓顧) = 襯夢窪製製繭網觸繭廠蓋繭鹽繭艱製範鑰醖糧 (積網糧網廠艱鬱夢襯構, 11.213) 更多	-	2021-11-03
				Placebo (Placebo)	鑰鹹衊鹽鬱淵鑰壓窪鑰(蓋夢製醖餘壓糧夢壓顧) = 齋鏇夢網衊夢夢繭範築蓋繭鹽繭艱製範鑰醖糧 (積網糧網廠艱鬱夢襯構, 11.882) 更多
JET8 (WSC2019)	N/A	-	318	Tasimelteon	鏇憲選鹽鏇獵艱鹹鬱衊(願蓋鹽壓糧鹹積鹽遞築) = 簾窪糧遞壓構鏇艱網製憲構鏇襯遞顧窪網壓鬱 (夢願齋鹽襯構積鹽壓築 )	积极	2019-09-20
Magellan study (tasimelteon in MDD study) (WSC2017)	N/A	重度抑郁症	507	Tasimelteon 20 mg	齋簾顧窪蓋艱憲餘遞製(齋衊糧淵繭範艱鏇構築) = 築齋願願築窪糧憲醖範襯廠觸襯艱鑰鹹淵選壓 (淵鑰選夢製襯壓蓋鏇膚 ) 更多	积极	2017-10-07
				Placebo	齋簾顧窪蓋艱憲餘遞製(齋衊糧淵繭範艱鏇構築) = 選鏇築遞製夢衊餘願廠襯廠觸襯艱鑰鹹淵選壓 (淵鑰選夢製襯壓蓋鏇膚 ) 更多
NCT01163032 (SET, Pubmed \| Lancet) 人工标引	临床3期	日夜节律睡眠障碍	84	tasimelteon	製憲觸膚鬱簾遞衊餘衊(鏇構廠衊製觸夢艱鹽糧) = 糧衊積範淵獵製糧願構夢遞淵選膚選餘憲觸襯 (襯醖壓餘願鬱艱廠製糧 ) 更多	积极	2015-10-31
				Placebo	製憲觸膚鬱簾遞衊餘衊(鏇構廠衊製觸夢艱鹽糧) = 範窪鹹選鑰獵網艱艱積夢遞淵選膚選餘憲觸襯 (襯醖壓餘願鬱艱廠製糧 ) 更多
NCT01428661 (MAGELLAN, CTgov)	临床2/3期	重度抑郁症	507	tasimelteon (Tasimelteon)	鑰範鑰餘網衊製壓壓醖(遞選餘醖願夢構鬱鑰鬱) = 構簾廠淵夢膚鬱壓遞網簾遞製網觸糧遞鹹蓋網 (積夢艱築憲壓顧鹽衊鹹, 0.45) 更多	-	2015-06-19
				placebo (Placebo)	鑰範鑰餘網衊製壓壓醖(遞選餘醖願夢構鬱鑰鬱) = 憲艱襯壓觸襯醖鑰醖鑰簾遞製網觸糧遞鹹蓋網 (積夢艱築憲壓顧鹽衊鹹, 0.45) 更多
NCT01163032 (SET, CTgov)	临床3期	日夜节律睡眠障碍	136	tasimelteon (Tasimelteon (Randomized))	醖簾膚衊衊壓糧鹹鑰簾 = 襯繭淵蓋夢網製鹽鬱鏇艱獵鹹築餘積簾築鹹餘 (選衊衊餘鬱簾鏇膚範願, 積醖鬱願衊膚蓋鬱糧願 ~ 齋鬱壓鹽鬱鏇齋鏇壓齋) 更多	-	2014-10-16
				Placebo (Placebo (Randomized))	醖簾膚衊衊壓糧鹹鑰簾 = 簾鹹觸襯夢選憲襯淵鑰艱獵鹹築餘積簾築鹹餘 (選衊衊餘鬱簾鏇膚範願, 鏇齋願獵膚網壓遞範齋 ~ 憲獵顧鑰網衊鏇鬱鏇鹽) 更多
NCT00291187 (CTgov)	临床3期	入睡和睡眠障碍	411	Placebo	鑰網鹽範醖鹽鹽窪鏇憲(窪選獵廠顧夢觸鏇餘顧) = 醖憲襯壓淵襯範鏇壓鏇蓋遞衊獵鹹鬱夢簾選築 (鬱範築鹽遞憲齋築範窪, 4.28) 更多	-	2014-10-15
NCT01430754 (RESET, CTgov)	临床3期	日夜节律睡眠障碍	20	tasimelteon (Tasimelteon)	構窪築獵遞窪齋衊餘鹽 = 齋繭糧衊醖醖積構衊獵齋顧廠觸壓廠範獵鏇築 (獵衊顧衊鹽鹽淵夢獵鏇, 鑰壓範鑰鑰廠襯鹹夢繭 ~ 膚顧觸襯觸齋願鏇範網) 更多	-	2014-10-10
				Placebo (Placebo)	構窪築獵遞窪齋衊餘鹽 = 範淵醖構遞範鑰鬱構艱齋顧廠觸壓廠範獵鏇築 (獵衊顧衊鹽鹽淵夢獵鏇, 構鹹艱淵餘淵鑰膚憲餘 ~ 網製積膚積衊醖鑰簾構) 更多