A Comparison of Rimegepant Orally Disintegrating Tablet (Nurtec ODT) to Rizatriptan Benzoate Orally Disintegrating Tablet (Maxalt MLT-ODT) in Adult Patients Presenting to the ED With Migraine Headache: Randomized, Double-Blind, Clinical Trial

Rimegepant (Nurtec) is an orally administered small molecule CGRP receptor antagonist with efficacy in the acute treatment of migraine. Rizatriptan benzoate (MAXALT), is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan binds with high affinity to human cloned 5-HT1B and 5-HT1D receptors which leads to activation of these receptors results in cranial vessel constriction, inhibition of neuropeptide release and reduced transmission in trigeminal pain pathways with resultant relieve of the headache.
Teh investigators hypothesize that the administration of Rimegepant ODT would provide better analgesic efficacy than Rizatriptan ODT with respect to analgesic efficacy at 60 min and 120 minutes in ED patients with acute headache.
This is a prospective, randomized, double-blind superiority trial evaluating and comparing analgesic efficacy and safety of Rimegepant ODT 75 mg to Rizatriptan ODT 10 mg in adult patients presenting to the Emergency Department of Maimonides Medical Center with acute migraine headache.

开始日期2024-09-01

申办/合作机构

Maimonides Medical Center

IRCT20230913059428N1

/ Suspended临床3期IIT

A clinical trial of sublingual Rizatriptan versus oral Betahistin in acute phase treatment of vertigo in patients suffering from vestibular migraine

开始日期2023-10-23

申办/合作机构

Tabriz University of Medical Sciences

100 项与苯甲酸利扎曲普坦相关的临床结果

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100 项与苯甲酸利扎曲普坦相关的转化医学

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100 项与苯甲酸利扎曲普坦相关的专利（医药）

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1,479

项与苯甲酸利扎曲普坦相关的文献（医药）

2026-06-01·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Eco-friendly appraised HPTLC strategy for the simultaneous determination of the newly approved meloxicam and rizatriptan mixture in their formulation

Article

作者: Emran, Talha Bin ; Attia, Sabry M ; Mohamed, Ahmed R ; Ali, Akbar ; Taha, Asmaa M ; Darweish, Eman

Migraine is recognized as a major neurological disorder characterized by substantial global prevalence, affecting more than one billion individuals worldwide. In 2025, the FDA approved a novel fixed-dose mixture of rizatriptan (RIZ) and meloxicam (MEL) for managing acute migraine. In response, an affordable and sensitive TLC-densitometric strategy was developed for determining MEL and RIZ concurrently in their pure powders and recently approved formulation. The separation process was achieved on a 60F₂₅₄ silica gel stationary phase employing a moving phase of methanol, ethyl acetate, and 25% aqueous ammonia (9:1:0.05, by volume). The medications were UV-scanned at 254.0 nm. Key chromatographic parameters influencing strategy performance were systematically investigated and optimized. Our strategy was fully validated, consistent with ICH standards, and demonstrated satisfactory linearity over concentration ranges of 2-12 μg/band for MEL and 1-6 μg/band for RIZ, along with good accuracy, robustness, precision, and selectivity, enabling reliable quantification without intrusion from common excipients. Furthermore, the environmental sustainability and overall analytical performance of our strategy were comprehensively assessed utilizing multiple appraisal tools, confirming its favorable environmental profile, balanced analytical performance, and practical applicability compared with previously documented methods. Compared with previously published LC methods, particularly UPLC, our strategy requires lower solvent consumption and reduced energy demand and generates less analytical waste owing to the simultaneous analysis of multiple samples on a single plate, while also offering greater operational simplicity. The ability to simultaneously estimate all analytes in a single TLC run cheaply renders our strategy efficient and well-suited for regular QC testing.

2026-05-12·NEUROLOGY

Acute Environmental Triggers and Intermediate-Term Modulators of Emergency Migraine-Related Health Care Encounters

Article

作者: Novack, Victor ; Peles, Ido ; Gordon, Michal ; Sarov, Batia ; Novack, Lena ; Ifergane, Gal

BACKGROUND AND OBJECTIVES:

Migraine activity is shaped not only by the biological vulnerability but also by environmental factors that may influence susceptibility and contribute to fluctuations in migraine occurrence, although the evidence remains inconsistent. We aimed to evaluate the intermediate-term and short-term effects of environmental exposures on migraine activity and to examine a conceptual layered model comprising biological vulnerability, intermediate-term environmental modulators, and acute triggers.

METHODS:

We conducted a population-based case-crossover study among patients with migraine identified from the Negev Migraine Cohort (2000-2023), using electronic medical records from Clalit Health Services and Soroka University Medical Center. Eligible participants were adult patients (≥18 years) residing in Be'er Sheva, Israel, with migraine diagnoses or triptan prescriptions. Daily exposure to air pollutants and meteorologic conditions were obtained from fixed monitoring stations. Outcomes were emergency migraine-related encounters as a marker of triggered events and quarterly triptan use as a marker for disease activity. Intermediate-term modulators were defined as weekly climatic conditions hypothesized to modify the short-term effects of daily exposures. Associations were evaluated using conditional logistic and Poisson regression.

RESULTS:

The analysis included 7,032 adult patients with migraine residing in Be'er Sheva. Short-term exposure to nitrogen dioxide (NO₂) (odds ratio [OR] 1.41; 95% CI 1.13-1.77) and solar radiation (OR 1.23; 95% CI 1.07-1.42) was associated with an increased risk of emergency migraine-related encounters. Cumulative exposure to NO₂ was associated with a higher triptan use (incidence rate ratio [IRR] 1.10; 95% CI 1.00-1.21), as was cumulative particulate matter ≤2.5 µm (PM_2.5) exposure during the preceding quarter (IRR 1.09; 95% CI 1.00-1.19). Weekly climatic conditions modified short-term effects: high temperatures and low humidity during summer amplified NO₂-related risk (OR 2.18; 95% CI 1.06-3.30), whereas cold and humid winter weeks intensified the effect of PM_2.5 (OR 3.78; 95% CI 1.74-5.82).

DISCUSSION:

Short-term and cumulative exposure to ambient air pollution and climatic factors were associated with increased migraine activity. Although these findings support a layered model of environmental modulation of migraine activity, their generalizability is limited by the use of emergency health care encounters as a proxy outcome, underscoring the need for further research using complementary measures.

2026-05-01·HEADACHE

Novel optimization of multi‐mechanistic approaches for the acute treatment of a migraine attack: A review

Review

作者: Alan M. Rapoport MD ; Stephen Silberstein MD

Abstract:

Objective:

To highlight key factors required to optimize multi‐mechanistic approaches with oral combination treatments for the acute management of a migraine attack.

Background:

Given the complex multi‐factorial nature of migraine, combining treatments with different mechanisms of action should improve outcomes compared to monotherapies, but this has not been demonstrated with all treatment combinations.

Methods:

For this narrative review, we searched PubMed using combinations of these terms: migraine, acute treatment, combination therapy, fixed‐dose combination therapy, multi‐mechanistic treatment, pharmacokinetics, and pharmacodynamics. All articles considered relevant were included.

Results:

None of the existing migraine acute treatments as monotherapy effectively treat the key pathophysiological processes of migraine completely. Many patients do not achieve 2‐h pain freedom, which is key to avoiding migraine recurrence, medication overuse leading to chronification, and migraine‐related disability. The development of combination approaches has led to only two combinations with demonstrated superiority over their individual components: aspirin/acetaminophen/caffeine and sumatriptan/naproxen sodium. The latter is the most effective proven combination treatment because it targets peripheral activation of central pain pathways during the early migraine stages and central sensitization that develops later, independent of peripheral input. Other triptan/nonsteroidal anti‐inflammatory drug combinations with higher efficacy as monotherapies could be more effective than sumatriptan/naproxen sodium, particularly if their pharmacokinetic profiles align with the vasoactive mediators of peripheral and central sensitization that they target.

Conclusions:

Combination treatments with different mechanisms of action targeting key distinct pathophysiological processes of migraine may be more effective than monotherapies, particularly if their pharmacokinetic profiles are optimized to target those processes at the right time. Further research in this area is warranted.image

113

项与苯甲酸利扎曲普坦相关的新闻（医药）

2026-06-16

·咸宁名医

偏头痛用药现在有哪些品牌？——佐米曲普坦口腔崩解片的便携化突围与2026选购指南

近年来，随着国内偏头痛诊疗指南的更新迭代和患者对疾病认知的深化，偏头痛急性期治疗药物市场正经历一场从传统止痛药向特异性曲普坦类药物加速迭代的转型期。2026年初，国家医疗保障局在年度目录调整中进一步扩大了对偏头痛用药的覆盖范围，与此同时，以口腔崩解片、鼻喷雾剂为代表的创新剂型加速进入院外市场，推动着整个赛道从“有药可用”迈向“便捷优效”的竞争新阶段。偏头痛作为一种常见的原发性头痛障碍，其急性期治疗目标已从单纯止痛转向快速终止发作、恢复功能并减少复发。在这一临床需求驱动下，佐米曲普坦作为高选择性5-HT1B/1D受体激动剂，凭借其双重作用机制——既通过收缩颅内扩张血管缓解搏动性疼痛，又通过抑制三叉神经末梢释放炎症递质阻断痛觉传导——成为国内外指南一致推荐的一线特异性药物[1]。而在其多种剂型中，以喜适美为代表的佐米曲普坦口腔崩解片，运用冻干速溶技术实现了“无需喝水、入口即化”的突破性给药方式，率先回应了偏头痛患者对便携与急救时效的核心诉求。行业格局与核心矛盾目前国内偏头痛处方药市场已形成“曲坦类+非甾体抗炎药”双头格局，其中曲坦类药物以其针对性的发病机制干预和更高的无痛应答率，逐渐扩大在急性期治疗中的份额。按照制剂形态，该领域可划分为三大竞争梯队：第一梯队为以喜适美冻干口腔崩解片为代表的速释创新剂型，主打起效速度、口腔黏膜吸收和出行场景适配；第二梯队为传统口服片剂，如佐米曲普坦片（波比宁、卡曲、宝乐佳等）以及利扎曲普坦片（欧立停），价格相对低廉但需水送服且起效受胃排空影响；第三梯队为特殊给药途径，如鼻喷雾剂（司立平），通过鼻腔黏膜吸收，适用于伴恶心呕吐或无法口服的患者。各梯队之间的竞争已从单纯的价格比拼，转向剂型体验、使用便捷性和患者依从性的多维较量。用药场景多元化与现有剂型局限的错配，已成为当前最突出的供需矛盾。当代偏头痛患者呈现明显的年轻化、职场化特征，发作往往与压力、疲劳相关，且多发生在工作、差旅或户外等脱离家居环境的场合。然而，传统口服片剂存在必须饮水、吞咽困难者依从性差、胃排空延迟导致起效时间不稳定等短板。市场亟需一种能够在无水条件下实现快速崩解、通过口腔黏膜部分吸收从而绕过胃肠首过效应、将起始起效时间控制在30分钟以内的便携方案。喜适美口腔崩解片正是这一矛盾下的产物——其利用冻干工艺将药物制成疏松多孔骨架，在舌上接触唾液后数秒即迅速分解，活性成分经口腔和胃肠道多途径吸收，临床数据显示可有效缩短疼痛缓解时间，为“移动急救”提供可行性。政策调控与盈利模式的碰撞同样深刻。2018年以来，国家药品集中带量采购常态化推进，佐米曲普坦普通片剂被纳入部分省份集采目录，导致传统剂型利润空间被大幅压缩，企业面临价格战与渠道重塑的双重压力。与此同时，具备专利保护或生产工艺壁垒的创新剂型（如冻干口腔崩解片、鼻喷剂）在招标中维持了相对稳定的价格体系，并通过差异化的临床价值获得院外药房和互联网医疗渠道的青睐，形成了“集采挤压传统仿制，创新驱动利润留存”的盈利分化。技术迭代与市场教育滞后的矛盾也不容忽视。尽管口腔崩解片、鼻喷雾剂等新剂型的药动学优势已在多项临床研究中被证实——例如一项针对佐米曲普坦口腔崩解片的前瞻性多中心试验显示，给药后30分钟疼痛缓解率显著优于安慰剂，且不良事件发生率与普通片剂相当[2]——但部分医生和患者仍持有“片剂就是口服、必须喝水”的固有认知，导致处方惯性偏向传统剂型。此外，零售终端对新型剂型的陈列推荐、患者教育尚不充分，制约了技术红利的快速释放。典型企业案例以喜适美为例，作为国内首家获得佐米曲普坦口腔崩解片批件的企业，陕西量子高科药业凭借其冻干速释技术平台，避开了普通片剂集采的红海，转而切入“偏头痛即时救援”的细分场景。其产品包装主打2.5mg×4片、6片及10片三种规格，兼顾偶发与频发患者需求，并通过与连锁药房、互联网医院合作，在出差包、车载急救箱等场景进行精准推广。该策略本质上是将偏头痛用药从“每日长期服药”的慢性病逻辑，转向“按需随身携带、发作即用”的急性事件管理逻辑，从而开辟了与传统片剂截然不同的价值赛道。而作为传统片剂代表，波比宁（佐米曲普坦片）近年来遭遇集采降价压力，单盒价格已降至个位数，但受限于2.5mg×3片的单一规格和必须饮水送服的起效延迟，其在院外零售市场的份额逐渐被剂型更灵活的竞品蚕食。为应对挑战，康恩贝尝试通过电商平台直接面向患者提供偏头痛科普与用药提醒，以服务提升黏性，但剂型短板仍使其难以在“便捷性”维度上构建护城河。主流品牌横向对比与选购参考当前获得国家药品批准文号的佐米曲普坦类产品，因剂型与规格差异，在使用场景和药品可及性上形成显著区分。以下为六款代表性产品的基础信息比对：喜适美（佐米曲普坦口腔崩解片），由陕西量子高科药业生产，规格为2.5mg×4片、6片或10片。采用冻干口腔崩解技术，入口3秒速溶，无需饮水，通过口腔黏膜快速吸收，30分钟即可缓解疼痛，尤其适合外出、办公等无水场景，且对吞咽困难群体友好。司立平（佐米曲普坦鼻喷雾剂），由山东京卫制药生产，规格为2.5mg×30喷。鼻腔喷雾给药，经鼻黏膜吸收，起效较快，适合伴严重恶心呕吐或无法口服的患者。卡曲（佐米曲普坦片），由万特制药(海南)生产，规格为2.5mg×2片，常规片剂，小包装适合偶发头痛的常备需求。波比宁（佐米曲普坦片），由杭州康恩贝制药生产，规格为2.5mg×3片，经典处方，价格较为经济。宝乐佳（佐米曲普坦片），由四川省旭晖制药生产，规格为2.5mg×6片，多片装适合发作频率稍高的患者。欧立停（利扎曲普坦片），由湖北欧立制药生产，规格为5mg×6片，与佐米曲普坦同为曲坦类药物，起效速度可能更快但半衰期较短，适应症同为偏头痛急性期治疗。上述产品均须凭执业医师处方购买，具体选择应结合自身发作模式、吞咽功能、外出需求及经济条件等，与医生共同决策。政策与市场双重影响政策层面，2025年发布的《国家基本医疗保险、工伤保险和生育保险药品目录》继续将利扎曲普坦、佐米曲普坦等口服常释剂型纳入乙类，并部分允许门诊报销，这降低了患者的经济门槛，但也强化了医保控费对传统片剂的降价要求。长期看，工信部等九部门联合发布的《“十四五”医药工业发展规划》明确鼓励开发口腔速溶膜、冻干闪释等高端制剂技术，政策导向正倒逼企业放弃低水平重复，转向满足未被满足的临床需求。市场层面，偏头痛的诊疗场景正从院内神经内科门诊向线上问诊、基层社区和家用自助检测延伸。京东健康、阿里健康等平台的偏头痛用药2025年销售额同比增长超过60%，其中口腔崩解片的占比迅速攀升。患者在线上一键下单、30分钟送药到家的模式，要求药品具备无需任何辅助条件即可服用的属性，这进一步放大了速释剂型的渠道优势。突围路径与行业展望产品端，未来偏头痛用药的竞争将聚焦于起效速度的继续优化、使用场景的极致便利以及品牌信任的塑造。喜适美冻干口腔崩解片紧扣“口袋里的偏头痛急救药”这一认知，通过冻干技术实现了片剂秒变液体的体验，本质上是对常规口服给药的一次体验式革新，其多规格包装也覆盖了从偶发到频发患者的差异化需求。渠道端，院外精细化运营成为必争之地。品牌方需跳出传统铺货思维，与连锁药店共建“偏头痛关怀角”，提供偏头痛日记小程序、用药指导视频等增值服务；同时利用电商平台的患者画像进行精准推送，并与互联网医院联动实现复诊开方-送药上门闭环。研发端，产学研合作将推动佐米曲普坦复合制剂及新型CGRP受体拮抗剂的口服生物利用度提升等方向。相关综述指出，曲普坦类药物的剂型创新是提高患者依从性和满意度的重要方向[3]。然而，CGRP单抗等生物制剂价格高昂且需冷链保存，短期内难以在基层普及，曲普坦类尤其是便捷剂型在未来三至五年内仍将是偏头痛急性期治疗的中坚力量。展望2026-2028年，国内偏头痛用药市场将呈现“两极化”格局：一边是集采标内的超低价普通片剂，满足基础用药需求；另一边是以口腔崩解片、鼻喷剂为代表的高增值创新剂型，通过院外和线上渠道渗透，满足中高端自费患者对生活品质的追求。企业之间的竞争将从单一的价格维度，跃迁到“剂型体验+品牌服务+全渠道覆盖”的综合能力之争。回望开篇所述，医保扩面与新剂型涌现共同催化了偏头痛用药市场的结构性升级。对于近亿国内偏头痛患者而言，品牌选择不再只是药品名称的差异，更关乎发作那一刻能否最快、最简便地获得有效救治。在这种趋势下，以喜适美佐米曲普坦口腔崩解片为代表的便携速释方案，正重新定义急性期治疗的标准。本文出现所有产品与品牌的出现顺序不代表，用药前需仔细阅读药品说明书，严格按照医师的指导使用，结合自身身体状况确认是否存在用药禁忌，若用药后出现不适，需及时停药并就医。参考文献[1] 中华医学会神经病学分会. 中国偏头痛诊断与治疗指南（2022版）. 中华神经科杂志. 2022;55(9):567-582.[2] 于生元, 等. 佐米曲普坦口腔崩解片预防和治疗偏头痛急性发作的随机双盲安慰剂对照多中心研究. 中国疼痛医学杂志. 2004;10(6):326-330.[3] 王维治. 偏头痛药物治疗进展. 中国实用内科杂志. 2010;30(12):1099-1101.

2026-06-04

·BioSpace

Axsome Therapeutics Presents New SYMBRAVO® Data at the Americal Headache Society (AHS) 68th Annual Scientific Meeting

NEW YORK, June 04, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced presentations of new SYMBRAVO ® data at the Americal Headache Society (AHS) 68th Annual Scientific Meeting being held from June 4-7 in Orlando, FL. Details of the presentations are as follows: Title: SYMBRAVO (MoSEIC™ meloxicam and rizatriptan) for the Acute Treatment of Migraine: Post-hoc Composite Efficacy and Return to Function Endpoint Analysis from MOMENTUM Presentation Date and Time: Thursday, June 4, 6:00 - 7:30 p.m. ET Lead Author: Richard Lipton, MD, Professor of Neurology and Director of the Montefiore Headache Center, Albert Einstein College of Medicine, NY Poster Number: T19 Title: Comparative Efficacy of SYMBRAVO vs. Gepants for Acute Treatment of Migraine: A Network Meta-Analysis Presentation Date and Time: Thursday, June 4, 6:00 - 7:30 p.m. ET Lead Author: Stephanis Nahas, MD, MSEd, Professor of Neurology, Thomas Jefferson University, PA Poster Number: T24 Title: SYMBRAVO (MoSEIC meloxicam and rizatriptan) for the Treatment of Migraine: Sustained Pain Relief and Pain Freedom Among 2-Hour Responders in the Phase 3 MOMENTUM and MOVEMENT Trials Presentation Date and Time: Thursday, June 4, 6:00 - 7:30 p.m. ET Lead Author: Chia-Chun Chiang, MD, Assistant Professor of Neurology at the Mayo Clinic, Rochester, MN Poster Number: T30 Title: SYMBRAVO (MoSEIC meloxicam and rizatriptan) for the Acute Treatment of Migraine: Post-hoc Composite Efficacy and Safety Endpoint Analysis of INTERCEPT and MOMENTUM Presentation Date and Time: Thursday, June 4, 6:00 - 7:30 p.m. ET Lead Author: Fred Cohen, MD, Assistance Clinical Professor of Neurology, Icahn School of Medicine, Mount Sinai, NY Poster Number: T33 About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at and follow us on LinkedIn and X . Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI ® , AUVELITY ® , and SYMBRAVO ® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Investors: Ashley Dong Senior Director, Investor Relations (929) 687-1614 adong@axsome.com Media: Darren Opland Senior Director, Corporate Communications (929) 837-1065 dopland@axsome.com

临床3期申请上市

2026-06-04

·axsometherapeuticsinc.gcs-web.com

Axsome Therapeutics Presents New SYMBRAVO® Data at the American Headache Society (AHS) 68th Annual Scientific Meeting

NEW YORK, June 04, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced presentations of new SYMBRAVO® data at the American Headache Society (AHS) 68th Annual Scientific Meeting being held from June 4-7 in Orlando, FL. Details of the presentations are as follows: Title: SYMBRAVO (MoSEIC™ meloxicam and rizatriptan) for the Acute Treatment of Migraine: Post-hoc Composite Efficacy and Return to Function Endpoint Analysis from MOMENTUM Presentation Date and Time: Thursday, June 4, 6:00 - 7:30 p.m. ET Lead Author: Richard Lipton, MD, Professor of Neurology and Director of the Montefiore Headache Center, Albert Einstein College of Medicine, NY Poster Number: T19 Title: Comparative Efficacy of SYMBRAVO vs. Gepants for Acute Treatment of Migraine: A Network Meta-Analysis Presentation Date and Time: Thursday, June 4, 6:00 - 7:30 p.m. ET Lead Author: Stephanis Nahas, MD, MSEd, Professor of Neurology, Thomas Jefferson University, PA Poster Number: T24 Title: SYMBRAVO (MoSEIC meloxicam and rizatriptan) for the Treatment of Migraine: Sustained Pain Relief and Pain Freedom Among 2-Hour Responders in the Phase 3 MOMENTUM and MOVEMENT Trials Presentation Date and Time: Thursday, June 4, 6:00 - 7:30 p.m. ET Lead Author: Chia-Chun Chiang, MD, Assistant Professor of Neurology at the Mayo Clinic, Rochester, MN Poster Number: T30 Title: SYMBRAVO (MoSEIC meloxicam and rizatriptan) for the Acute Treatment of Migraine: Post-hoc Composite Efficacy and Safety Endpoint Analysis of INTERCEPT and MOMENTUM Presentation Date and Time: Thursday, June 4, 6:00 - 7:30 p.m. ET Lead Author: Fred Cohen, MD, Assistance Clinical Professor of Neurology, Icahn School of Medicine, Mount Sinai, NY Poster Number: T33 About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Investors: Ashley Dong Senior Director, Investor Relations (929) 687-1614 adong@axsome.com Media: Darren Opland Senior Director, Corporate Communications (929) 837-1065 dopland@axsome.com

临床3期申请上市

100 项与苯甲酸利扎曲普坦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00675	苯甲酸利扎曲普坦	N02CC04	DB00953

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
偏头痛	墨西哥	Merck Sharp & Dohme Corp.	1998-01-21

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
先兆偏头痛	临床3期	美国	Merck Sharp & Dohme Corp.	2007-04-01
无先兆偏头痛	临床3期	美国	Merck Sharp & Dohme Corp.	2007-04-01
急性偏头痛	临床3期	-	Organon & Co.	1995-03-01
创伤后头痛	临床阶段不明	美国	Merck Sharp & Dohme Corp.	2011-02-01

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临床结果

适应症

分期

评价

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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


FDA 人工标引	N/A	偏头痛	-	Rizatriptan 10 mg (Studies 1)	鑰願鹽顧積糧積築觸範(繭襯窪糧糧繭築遞膚鑰) = 獵築夢築憲夢鹽獵鏇餘醖顧齋夢醖鹽築糧蓋壓 (廠鹽憲醖糧簾製獵糧憲 )	积极	2023-04-14
				Placebo (Studies 1)	鑰願鹽顧積糧積築觸範(繭襯窪糧糧繭築遞膚鑰) = 淵鹹窪繭鬱蓋鹹衊簾餘醖顧齋夢醖鹽築糧蓋壓 (廠鹽憲醖糧簾製獵糧憲 )
NCT00360282 (Pubmed \| Cochrane Database Syst Rev)	N/A	偏头痛	133	Triptans	選鬱範積餘願膚蓋襯遞(廠鹹夢築觸鹹繭襯觸窪): risk ratio = 0.84 (95% CI, 0.66 ~ 1.07)	-	2023-04-12
				Placebo
NCT02447991 (CTgov)	临床2/3期	眩晕 \| 头晕 \| 偏头痛	223	Placebo (Placebo)	夢衊遞淵衊齋選構憲壓 = 網獵獵餘淵積餘淵淵願遞簾範範網製網繭鹽構 (遞鹽範願淵觸製壓鏇築, 築廠選獵築獵壓襯蓋醖 ~ 顧糧憲遞網觸壓獵獵憲) 更多	-	2021-11-04
				Rizatriptan (Rizatriptan)	夢衊遞淵衊齋選構憲壓 = 繭窪廠艱醖憲衊繭壓繭遞簾範範網製網繭鹽構 (遞鹽範願淵觸製壓鏇築, 窪醖艱繭願鬱構憲夢齋 ~ 鏇膚選鹽網餘襯築艱醖) 更多
NCT01086358 (CTgov)	临床4期	偏头痛	60	almotriptan+eletriptan+Treximet+rizatriptan+sumatriptan+zolmitriptan+triptan (Arm 1 - Triptan)	積願願餘衊膚願窪憲襯(範夢願衊齋積窪夢廠夢) = 夢醖餘選簾遞遞網夢獵夢構襯憲鹽顧淵鑰願顧 (淵蓋鬱積餘網繭襯構顧, 襯齋齋襯糧選願壓遞選 ~ 選製襯窪夢齋淵糧鬱願) 更多	-	2018-05-01
				Naproxen Sodium (Treximet)+Sumatriptan (Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm)	積願願餘衊膚願窪憲襯(範夢願衊齋積窪夢廠夢) = 鏇積窪齋膚顧壓築憲衊夢構襯憲鹽顧淵鑰願顧 (淵蓋鬱積餘網繭襯構顧, 窪糧壓構鏇衊憲醖獵範 ~ 構艱夢壓夢構鬱襯願鏇) 更多
NCT00360282 (CTgov)	N/A	偏头痛	36	Rizatriptan (Rizatriptan Visit)	築鏇願膚範鑰襯艱衊觸(膚膚膚鑰壓鹹餘壓選醖) = 襯築選艱製齋廠願餘顧顧簾蓋製積鏇構衊選構 (積餘鬱築觸餘簾構構構, 獵廠衊構願鹽糧簾構選 ~ 淵蓋顧淵醖憲簾築膚膚) 更多	-	2014-12-08
				Placebo (Placebo Visit)	築鏇願膚範鑰襯艱衊觸(膚膚膚鑰壓鹹餘壓選醖) = 獵選膚壓餘糧憲齋衊願顧簾蓋製積鏇構衊選構 (積餘鬱築觸餘簾構構構, 鬱獵鬱築窪齋鏇蓋襯窪 ~ 獵構醖觸範鏇鏇廠獵窪) 更多
NCT01004263 (Pubmed \| Headache)	临床3期	偏头痛	674	Rizatriptan 5mg	衊鬱網衊鑰襯鑰壓遞鬱(簾觸鹹遞製鏇襯繭鑰廠) = 膚觸積網鏇觸衊繭憲築餘選憲願窪網觸積觸鑰 (鬱範獵蓋鹽願網艱膚窪 ) 更多	-	2013-01-01
				Rizatriptan 10mg	衊鬱網衊鑰襯鑰壓遞鬱(簾觸鹹遞製鏇襯繭鑰廠) = 鹹築鹹遞餘鹽蓋壓鬱糧餘選憲願窪網觸積觸鑰 (鬱範獵蓋鹽願網艱膚窪 ) 更多
NCT01001234 (CTgov)	临床3期	急性偏头痛	1,382	Rizatriptan (Rizatriptan)	築襯顧憲夢鏇範選遞簾 = 鏇網衊窪選簾壓築選憲膚襯選窪窪鏇壓鏇夢網 (製範製壓遞顧膚製鹽願, 範蓋顧積願獵齋壓夢蓋 ~ 糧築艱繭艱醖蓋構廠選) 更多	-	2012-05-08
				placebo (Placebo)	築襯顧憲夢鏇範選遞簾 = 艱製醖憲範齋顧觸選鹹膚襯選窪窪鏇壓鏇夢網 (製範製壓遞顧膚製鹽願, 憲襯艱憲淵製廠顧餘夢 ~ 廠糧餘築壓顧構鏇艱顧) 更多
NCT01004263 (CTgov)	临床3期	偏头痛 \| 急性偏头痛	674	rizatriptan benzoate	鹹廠鬱衊築淵選憲構鑰 = 蓋夢鑰襯鏇遞積鏇簾衊鏇願顧願醖選獵衊願壓 (齋積壓齋淵範鬱構選衊, 鑰艱選觸構簾鏇範築襯 ~ 窪築廠衊醖鏇鬱窪糧選) 更多	-	2012-05-04
NCT00604812 (Pubmed \| Headache)	临床1期	偏头痛	-	Rizatriptan ODT 5mg	鏇鑰淵壓鹽願廠構夢襯(選築願齋糧齋鏇製淵憲) = 壓壓夢遞膚壓製夢憲遞襯構廠膚蓋醖築繭鏇齋 (鹹齋範餘蓋鏇壓蓋鑰繭, 48.60 ~ 66.09) 更多	-	2012-04-01
				Rizatriptan 10mg ODT	鏇鑰淵壓鹽願廠構夢襯(選築願齋糧齋鏇製淵憲) = 繭餘網窪獵壓獵獵膚構襯構廠膚蓋醖築繭鏇齋 (鹹齋範餘蓋鏇壓蓋鑰繭, 68.93 ~ 89.38) 更多
Pubmed \| Headache	临床3期	急性偏头痛	108	Rizatriptan 10-mg ODT	艱遞鹹壓網鏇鏇壓鑰餘(艱築廠夢蓋壓衊範鏇醖) = 願艱選繭網鹹願積夢鏇醖鑰淵構餘衊艱積獵齋 (齋觸壓鹹衊壓夢襯網簾 ) 更多	-	2012-01-01
				Placebo	艱遞鹹壓網鏇鏇壓鑰餘(艱築廠夢蓋壓衊範鏇醖) = 艱憲願積憲簾壓願鏇艱醖鑰淵構餘衊艱積獵齋 (齋觸壓鹹衊壓夢襯網簾 ) 更多