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A single oral dose of SYMBRAVO provided rapid migraine pain freedom and return to normal functioning within 2 hours, and sustained efficacy through 24 and 48 hours

单次口服SYMBRAVO可快速缓解偏头痛，并在2小时内恢复正常功能，并在24和48小时内持续有效

85% and 77% of patients treated with a single dose of SYMBRAVO did not require migraine rescue medication within 24 hours in two Phase 3 studies

在两项3期研究中，85%和77%接受单剂量SYMBRAVO治疗的患者在24小时内不需要偏头痛抢救药物

SYMBRAVO demonstrated superior efficacy across a broad range of migraine severity (mild, moderate, and severe), and in head-to-head evaluation

SYMBRAVO在广泛的偏头痛严重程度（轻度、中度和重度）以及头对头评估中表现出优异的疗效

SYMBRAVO incorporates Axsome’s rapid absorption technology and mechanisms that target multiple migraine attack pathways

SYMBRAVO结合了Axsome的快速吸收技术和针对多种偏头痛发作途径的机制

Company to host conference call and webcast

公司将主持电话会议和网络广播

Friday, January 31

1月31日，星期五

, at

，位于

8:00 AM

8： 上午00点

Eastern

东部

NEW YORK

纽约

,

,

Jan. 30, 2025

(GLOBE NEWSWIRE) --

（环球通讯社）--

Axsome Therapeutics, Inc.

Axsome Therapeutics公司。

(NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the

（纳斯达克：AXSM），一家引领中枢神经系统（CNS）疾病治疗新时代的生物制药公司，今天宣布

U.S. Food and Drug Administration

U、 美国食品和药物管理局

(FDA) has approved SYMBRAVO

（FDA）已批准SYMBRAVO

®

®

(meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.

（美洛昔康和利扎曲普坦）用于急性治疗成人偏头痛伴或不伴先兆。

1

1

SYMBRAVO represents a novel multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack. SYMBRAVO can rapidly eliminate migraine pain and return patients to normal functioning, with efficacy sustained through 24 and 48 hours in some patients after a single dose.

。SYMBRAVO可以迅速消除偏头痛并使患者恢复正常功能，单次给药后某些患者的疗效持续24和48小时。

The efficacy of SYMBRAVO was demonstrated across a broad range of settings including at the earliest onset of migraine when the pain was mild, in patients with moderate and severe migraine pain, and in those with a history of various responses to prior acute treatments. The Company expects SYMBRAVO to be commercially available in the .

SYMBRAVO的疗效在广泛的环境中得到了证实，包括在偏头痛最早发作时，疼痛较轻，中度和重度偏头痛患者以及对先前急性治疗有各种反应史的患者。该公司预计SYMBRAVO将在年上市。

U.S.

U、 S。

in approximately four months.

大约四个月后。

Richard B. Lipton

理查德·利普顿

, MD, Professor of Neurology and Director of the Montefiore Headache Center,

，医学博士，神经病学教授，蒙特菲奥头痛中心主任，

Albert Einstein College of Medicine

爱因斯坦医学院

, commented, “A significant proportion of migraine patients experience inadequate efficacy with currently available acute treatments, leading to even greater suffering, and an increased risk of worsening of migraine pain and attack frequency. Results of multiple clinical trials demonstrate that SYMBRAVO can provide rapid and long-lasting freedom from migraine pain, whether treatment is taken early in the attack while the pain is mild, or later in the attack when the pain may be severe.

，评论道，“相当一部分偏头痛患者目前可用的急性治疗效果不佳，导致更大的痛苦，偏头痛和发作频率恶化的风险增加。多项临床试验的结果表明，SYMBRAVO可以提供快速和持久的偏头痛自由，无论是在发作早期疼痛轻微时进行治疗，还是在发作后期疼痛可能严重时进行治疗。

The approval of SYMBRAVO is a long awaited and much welcomed advancement for clinicians and our patients, providing a new, meaningful treatment option.”.

SYMBRAVO的批准对于临床医生和我们的患者来说是一个期待已久且备受欢迎的进步，提供了一种新的，有意义的治疗选择。”。

Stewart Tepper

斯图尔特 Tepper

, MD, Clinical Professor of Neurology at the

，医学博士，神经病学临床教授

Geisel School of Medicine

盖塞尔医学院

at Dartmouth and Vice President of the

New England Institute for Neurology and Headache

新英格兰神经病学和头痛研究所

, said, “Migraine is a debilitating condition that affects millions of Americans. Unfortunately, many patients still struggle to find an option that effectively treats their attacks and is both safe and well tolerated, which creates a great need for new migraine medicines. SYMBRAVO’s approval by the FDA provides a new medicine for physicians and patients that was designed to target key unmet needs in the migraine treatment space.

他说：“偏头痛是一种使人衰弱的疾病，影响着数百万美国人。不幸的是，许多患者仍然难以找到一种有效治疗其发作且安全且耐受性良好的选择，这就迫切需要新的偏头痛药物。SYMBRAVO获得FDA的批准，为医生和患者提供了一种新药，旨在针对偏头痛治疗领域尚未满足的关键需求。

The clinical data supporting its approval validates the additive benefit of SYMBRAVO’s multi-mechanistic design and demonstrates its potential to make a meaningful difference for the migraine community.”.

支持其批准的临床数据验证了SYMBRAVO多机制设计的附加益处，并证明了其对偏头痛社区产生有意义影响的潜力。”。

Susan Doughty

苏珊·多尔蒂

, Executive Director of the

，执行董事

Coalition for Headache and Migraine Patients

头痛和偏头痛患者联盟

(CHAMP), added, “Migraine is one of the most misunderstood and stigmatized neurological diseases, despite the fact that one in four households in the

（CHAMP）补充道：“偏头痛是最被误解和污名化的神经系统疾病之一，尽管事实上，美国四分之一的家庭

U.S.

U、 S。

includes someone living with it. This widespread lack of understanding creates unnecessary barriers for individuals seeking proper diagnosis, care, and treatment. CHAMP, alongside our 20 plus dedicated coalition organizations and patient advocates, is committed to empowering the migraine community by providing education, reducing stigma, and advocating for fair and equitable access to treatment options.

包括与它一起生活的人。这种普遍缺乏理解为寻求适当诊断，护理和治疗的个人创造了不必要的障碍。CHAMP与我们20多个专门的联盟组织和患者倡导者一起，致力于通过提供教育，减少耻辱感以及倡导公平和公平地获得治疗选择来增强偏头痛社区的能力。

The approval of SYMBRAVO as a new acute treatment for migraine is an important step forward, offering a new option for people seeking relief. We also see this moment as an opportunity to continue to shine a bright light on migraine, fostering greater awareness and helping to dismantle the stigma that so often surrounds this disease.”.

SYMBRAVO被批准为偏头痛的一种新的急性治疗方法，这是向前迈出的重要一步，为寻求缓解的人提供了新的选择。我们也将这一时刻视为一个机会，继续为偏头痛提供光明，培养更高的意识，并帮助消除围绕这种疾病的耻辱感。”。

The FDA approval of SYMBRAVO is based on the results of the Phase 3 MOMENTUM trial that treated migraine of moderate and severe pain intensity, the Phase 3 INTERCEPT trial that treated migraine when the initial pain was mild, and the Phase 3 MOVEMENT long-term open label safety trial. In this comprehensive clinical program, over 21,000 migraine attacks were treated with SYMBRAVO..

FDA对SYMBRAVO的批准是基于治疗中度和重度疼痛强度偏头痛的3期MOMENTUM试验的结果，在初始疼痛轻微时治疗偏头痛的3期INTERCEPT试验以及3期运动长期开放标签安全试验。在这项综合临床计划中，超过21000例偏头痛发作接受了SYMBRAVO治疗。。

In the MOMENTUM trial, SYMBRAVO demonstrated a statistically significantly greater percentage of patients achieving pain freedom and freedom from their most bothersome symptom (photophobia, phonophobia, nausea) 2 hours after dosing compared to placebo. SYMBRAVO also demonstrated statistical superiority for pain relief (reduction of moderate or severe pain to no pain or mild pain) and the ability to perform normal daily activities.

在MOMENTUM试验中，与安慰剂相比，SYMBRAVO在给药后2小时达到疼痛自由和免于最烦人症状（畏光，恐声，恶心）的患者比例在统计学上显着更高。。

The benefits of pain freedom at 2 hours were sustained through 24 and 48 hours for many patients. In a head-to-head comparison, SYMBRAVO demonstrated statistically significant superiority compared to rizatriptan on sustained pain freedom from 2 to 24 hours. Notably, these benefits were seen with only a single dose of SYMBRAVO.

对于许多患者来说，2小时无疼痛的好处持续到24小时和48小时。在头对头的比较中，与利扎曲普坦相比，SYMBRAVO在2至24小时的持续疼痛自由度方面表现出统计学上显着的优势。值得注意的是，只有单剂量的SYMBRAVO才能看到这些益处。

In the MOMENTUM trial, 77% of patients treated with SYMBRAVO did not require rescue medication within 24 hours post dose..

在MOMENTUM试验中，77%接受SYMBRAVO治疗的患者在给药后24小时内不需要急救药物。。

In the INTERCEPT trial, SYMBRAVO demonstrated a statistically significantly greater percentage of patients achieving pain freedom and freedom from their most bothersome symptom (photophobia, phonophobia, nausea) 2 hours after dosing compared to placebo. The benefits of pain freedom at 2 hours were sustained through 24 and 48 hours for many patients.

在INTERCEPT试验中，与安慰剂相比，SYMBRAVO在给药后2小时表现出统计学上显着更高比例的患者达到了疼痛自由，并且没有了最令人烦恼的症状（畏光，恐声，恶心）。对于许多患者来说，2小时无疼痛的好处持续到24小时和48小时。

Notably, these benefits were seen with only a single dose of SYMBRAVO. In the INTERCEPT trial, 85% of patients treated with SYMBRAVO did not require rescue medication within 24 hours post dose..

值得注意的是，只有单剂量的SYMBRAVO才能看到这些益处。在INTERCEPT试验中，85%接受SYMBRAVO治疗的患者在给药后24小时内不需要急救药物。。

The most common adverse reactions (≥1% and greater than placebo) in the controlled studies were somnolence and dizziness, being reported each in 2% and 1% of patients in the SYMBRAVO and placebo arms, respectively. The long-term safety of SYMBRAVO was demonstrated in the MOVEMENT trial, which assessed 706 patients dosing intermittently for up to 12 months and treating at least 2 migraines per month with SYMBRAVO..

对照研究中最常见的不良反应（≥1%且大于安慰剂）是嗜睡和头晕，分别在SYMBRAVO和安慰剂组中有2%和1%的患者报告。运动试验证明了SYMBRAVO的长期安全性，该试验评估了706名患者间歇性给药长达12个月，每月至少治疗2次偏头痛。。

SYMBRAVO is engineered with Axsome’s patented MoSEIC

SYMBRAVO采用Axsome的专利MoSEIC设计

TM

TM公司

(

(

Molecular Solubility Enhanced Inclusion Complex

分子溶解度增强的包合物

) rapid absorption technology. MoSEIC results in a five times faster median time to maximum plasma concentration for meloxicam while maintaining a long plasma half-life, enabling meloxicam’s use as a new molecular entity for the acute treatment of migraine. SYMBRAVO is protected by a robust patent estate extending out to at least 2040..

)快速吸收技术。MoSEIC使美洛昔康达到最大血浆浓度的中位时间缩短了五倍，同时保持了较长的血浆半衰期，使美洛昔康成为偏头痛急性治疗的新分子实体。SYMBRAVO拥有至少2040年的强大专利保护权。。

Herriot Tabuteau

Herriot Tabuteau

, MD, Chief Executive Officer of

，医学博士，首席执行官

Axsome Therapeutics

Axsome疗法

, said, “Today’s approval of SYMBRAVO marks an important milestone for the migraine community by providing a rationally designed novel acute treatment for this debilitating condition. Migraine attacks strike without warning, and disrupt the lives of estimated more than 39 million patients in the

他说：“今天对SYMBRAVO的批准标志着偏头痛社区的一个重要里程碑，它为这种衰弱的疾病提供了一种合理设计的新型急性治疗方法。偏头痛发作毫无预警，并扰乱了估计3900多万偏头痛患者的生活

U.S.

U、 S。

alone. SYMBRAVO provides patients and clinicians an important new option which can quickly stop a migraine attack, keep it away, and allow patients to resume their normal activities, with just a single dose. SYMBRAVO demonstrates Axsome’s commitment to developing and delivering differentiated new treatments to improve the lives of patients living with difficult to treat central nervous system disorders.”.

独自一人。SYMBRAVO为患者和临床医生提供了一个重要的新选择，它可以快速阻止偏头痛发作，远离偏头痛，并允许患者恢复正常活动，只需一剂。SYMBRAVO证明了Axsome致力于开发和提供差异化的新疗法，以改善难以治疗的中枢神经系统疾病患者的生活。”。

Conference Call Information

电话会议信息

Axsome will host a conference call and webcast on

Axsome将在

Friday, January 31

1月31日，星期五

, at

，位于

8:00 a.m. Eastern Time

8： 东部时间上午00点

to discuss the approval of SYMBRAVO. Dr.

讨论SYMBRAVO的批准。博士。

Stewart Tepper

斯图尔特 Tepper

, Clinical Professor of Neurology at the Geisel School of Medicine at Dartmouth and Vice President of the

达特茅斯盖塞尔医学院神经病学临床教授兼

New England Institute for Neurology and Headache

新英格兰神经病学和头痛研究所

, will join the call and will be available to answer questions during the Q&A session. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at .

，将加入通话，并在问答环节中回答问题。要参加现场电话会议，请拨打（877）405-1239（国内免费电话）或+1（201）389-0851（国际）。可以在公司网站“投资者”部分的“网络广播和演示”页面上访问实时网络广播。

axsome.com

axsome.com

. A replay of the webcast will be available for approximately 30 days following the live event.

现场活动结束后大约30天内，将提供网络广播的重播。

About Migraine

关于偏头痛

Migraine is a serious neurological condition characterized by recurrent attacks of pulsating, often severe and disabling head pain associated with nausea, sensitivity to light, and sensitivity to sound.

偏头痛是一种严重的神经系统疾病，其特征是反复发作搏动性头痛，通常是严重的致残性头痛，伴有恶心，对光线敏感和对声音敏感。

2

2

It is estimated that over 39 million Americans suffer from migraine, and it is the leading cause of disability among neurological disorders in

据估计，超过3900万美国人患有偏头痛，偏头痛是美国神经系统疾病中导致残疾的主要原因

the United States

美国

according to the

根据

American Migraine Foundation

美国偏头痛基金会

.

.

3

3

-

-（笑声）

5

5

Extensive surveys of migraine sufferers underscore the unmet need for therapies that work faster, more consistently, and result in less symptom recurrence.

对偏头痛患者的广泛调查强调了对更快，更一致且症状复发更少的疗法的需求尚未得到满足。

6

6

,

,

7

7

Over 70% of patients report experiencing an inadequate response to their oral, acute migraine treatment.

超过70%的患者报告对口服急性偏头痛治疗反应不足。

8

8

About SYMBRAVO

关于SYMBRAVO

SYMBRAVO is a novel, oral, single-dose medicine approved for the acute treatment of migraine with or without aura in adults. SYMBRAVO consists of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (

SYMBRAVO是一种新型口服单剂量药物，被批准用于成人偏头痛的急性治疗。SYMBRAVO由MoSEIC™美洛昔康和利扎曲普坦组成。美洛昔康是由Axsome的MoSEIC启用的偏头痛的新分子实体(

Molecular Solubility Enhanced Inclusion Complex

分子溶解度增强的包合物

) technology, which enables the rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID) and rizatriptan is a 5-HT

)该技术能够快速吸收美洛昔康，同时保持较长的血浆半衰期。美洛昔康是一种COX-2优先使用的非甾体抗炎药（NSAID），利扎曲普坦是一种5-HT

1B/1D

1B/1D

agonist. SYMBRAVO is designed to provide rapid, enhanced, and consistent migraine pain relief, and reduced symptom recurrence. The exact mechanism of action of SYMBRAVO in the treatment of acute migraine is unknown.

。SYMBRAVO旨在提供快速，增强和持续的偏头痛缓解，并减少症状复发。SYMBRAVO治疗急性偏头痛的确切作用机制尚不清楚。

For more information, visit

有关更多信息，请访问

www.symbravo.com

www.symbravo.com

.

.

INDICATION

指示

SYMBRAVO

SYMBRAVO 公司

®

®

(meloxicam and rizatriptan) is indicated for the acute treatment of migraine with or without aura in adults.

（美洛昔康和利扎曲普坦）适用于成人偏头痛伴或不伴先兆的急性治疗。

IMPORTANT SAFETY INFORMATION

重要安全信息

Limitations of Use

使用限制

SYMBRAVO is not indicated for the preventative treatment of migraine or for the treatment of cluster headache.

SYMBRAVO不适用于偏头痛的预防性治疗或丛集性头痛的治疗。

CONTRAINDICATIONS

禁忌症

SYMBRAVO is contraindicated in patients with:

SYMBRAVO禁用于以下患者：

Ischemic coronary artery disease or other significant underlying cardiovascular disease

缺血性冠状动脉疾病或其他重要的潜在心血管疾病

Coronary artery vasospasm

冠状动脉血管痉挛

In the setting of CABG surgery

在CABG手术中

History of stroke or transient ischemic attack

中风或短暂性脑缺血发作史

Hemiplegic or basilar migraine

偏瘫或基底偏头痛

Peripheral vascular disease

外周血管疾病

Ischemic bowel disease

缺血性肠病

Uncontrolled hypertension

控制不佳的高血压

Concomitant use of propranolol

同时使用普萘洛尔

Recent (within 24 hours) use of an ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), another 5-HT

最近（24小时内）使用含麦角胺的药物，麦角型药物（如二氢麦角胺或甲硫酰亚胺），另一种5-HT

1

1

agonist (e.g., another triptan)

激动剂（例如另一种曲普坦）

Concurrent administration or recent discontinuation (i.e., within the past 2 weeks) of a MAO-A inhibitor

MAO-a抑制剂的同时给药或最近停药（即在过去2周内）

Known hypersensitivity to SYMBRAVO, meloxicam, rizatriptan, NSAIDs, triptans, or any of the excipients in SYMBRAVO

已知对SYMBRAVO、美洛昔康、利扎曲普坦、NSAIDs、曲坦或SYMBRAVO中的任何赋形剂过敏

History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

服用阿司匹林或其他非甾体抗炎药后有哮喘、荨麻疹或其他过敏性反应史

Moderate to severe renal insufficiency in patients who are at risk for renal failure due to volume depletion or who are on dialysis

由于容量消耗或透析而有肾衰竭风险的患者的中度至重度肾功能不全

WARNINGS AND PRECAUTIONS

警告和注意事项

Cardiovascular Thrombotic Events, Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina

心血管血栓事件，心肌缺血，心肌梗塞和Prinzmetal心绞痛

: Perform cardiac evaluation in patients with multiple cardiovascular risk factors.

：对有多种心血管危险因素的患者进行心脏评估。

Arrhythmias

心律不整

: Discontinue dosing if arrhythmia occurs.

：如果发生心律失常，停止给药。

Cerebral Hemorrhage, Subarachnoid Hemorrhage, and Stroke

脑出血，蛛网膜下腔出血和中风

: Discontinue dosing if occurs.

。

Anaphylactic Reactions

过敏反应

: Seek emergency help if an anaphylactic reaction occurs.

：如果发生过敏反应，请寻求紧急帮助。

Chest/Throat/Neck/Jaw Pain, Tightness, Pressure, or Heaviness

胸部/喉咙/颈部/下巴疼痛、紧绷、压力或沉重

: Generally not associated with myocardial ischemia; evaluate patients at high risk.

：通常与心肌缺血无关；评估高危患者。

Gastrointestinal Ischemic Events, Peripheral Vasospastic Reactions

胃肠道缺血事件，外周血管痉挛反应

: Discontinue dosing if occurs.

。

Hepatotoxicity

肝毒性

: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

：告知患者肝毒性的警告迹象和症状。如果肝脏检查异常持续或恶化，或者出现肝病的临床体征和症状，则停止服用。

Hypertension

高血压

: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

：服用某些抗高血压药物的患者在服用NSAIDs时可能对这些疗法的反应受损。。

Heart Failure and Edema

心力衰竭和水肿

: Avoid use of SYMBRAVO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.

：除非预期益处超过心力衰竭恶化的风险，否则避免在严重心力衰竭患者中使用SYMBRAVO。

Renal Toxicity and Hyperkalemia

肾毒性和高钾血症

: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Use is not recommended in patients with moderate to severe renal insufficiency; avoid the use in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function..

：监测肾或肝功能不全，心力衰竭，脱水或血容量不足患者的肾功能。中度至重度肾功能不全患者不建议使用；除非预期益处超过肾功能恶化的风险，否则避免在晚期肾病患者中使用。。

Serious Skin Reactions

严重的皮肤反应

: Discontinue SYMBRAVO at first appearance of skin rash or other signs of hypersensitivity.

：首次出现皮疹或其他过敏迹象时停止服用SYMBRAVO。

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

嗜酸性粒细胞增多和全身症状的药物反应（DRESS）

: Discontinue SYMBRAVO and evaluate clinically.

：停止SYMBRAVO并进行临床评估。

Fetal Toxicity

胎儿毒性

: Limit use of NSAIDs, including SYMBRAVO, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus..

：由于羊水过少/胎儿肾功能不全的风险，在怀孕20至30周内限制使用非甾体抗炎药，包括SYMBRAVO。由于羊水过少/胎儿肾功能不全和胎儿动脉导管过早闭合的风险，避免在妊娠30周左右和妊娠后期使用非甾体抗炎药。。

Hematologic Toxicity

血液学毒性

: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.

：监测有贫血迹象或症状的患者的血红蛋白或血细胞比容。

Exacerbation of Asthma Related to Aspirin Sensitivity

与阿司匹林敏感性有关的哮喘恶化

: SYMBRAVO is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).

：SYMBRAVO是阿司匹林敏感哮喘患者的禁忌症。监测先前存在哮喘的患者（无阿司匹林敏感性）。

Medication Overuse Headache

药物过度使用头痛

: Detoxification may be necessary.

：可能需要排毒。

Serotonin Syndrome

血清素综合征

: Discontinue dosing if occurs.

。

Most common adverse reactions (

最常见的不良反应(

≥

≥

1% and greater than placebo)

比安慰剂高1%）

: dizziness and somnolence.

：头晕和嗜睡。

Use in specific populations:

在特定人群中使用：

Infertility:

不孕症：

NSAIDs are associated with reversible infertility. Consider withdrawal of SYMBRAVO in women who have difficulties conceiving.

。考虑在怀孕困难的女性中退出SYMBRAVO。

SYMBRAVO is available in 20 mg meloxicam / 10 mg rizatriptan tablets.

SYMBRAVO有20毫克美洛昔单抗/ 10毫克利扎SS利曲坦片剂。

Please see full

请查看完整信息

Prescribing Information

处方信息

, including

，包括

Boxed Warning

黑框警告

for risk of serious cardiovascular and gastrointestinal adverse events, and

严重心血管和胃肠道不良事件的风险，以及

Medication Guide

用药指南

.

.

About

关于

Axsome Therapeutics

Axsome疗法

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.

Axsome Therapeutics是一家生物制药公司，引领中枢神经系统（CNS）疾病治疗的新时代。我们通过确定护理中的关键差距来实现科学突破，并开发差异化产品，重点关注新的行动机制，从而在患者预后方面取得有意义的进步。

Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder and excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the .

我们业界领先的神经科学产品组合包括FDA批准的与嗜睡症和阻塞性睡眠呼吸暂停相关的重度抑郁症和白天过度嗜睡的治疗方法，以及针对影响全球1.5亿多人的各种严重神经和精神疾病的多个晚期发展计划。

United States

美国

. 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 the Company’s website at

.我们共同致力于解决大脑的一些最大问题，使患者及其亲人能够茁壮成长。欲了解更多信息，请访问公司网站

www.axsome.com

www.axsome.com

.

.

Forward Looking Statements

前瞻性声明

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.

本新闻稿中讨论的某些事项是“前瞻性声明”。在某些情况下，公司可能会使用“预测”，“相信”，“潜在”，“继续”，“估计”，“预期”，“预期”，“计划”，“打算”，“可能”，“可能”，“可能”，“可能”，“将会”，“应该”或其他表达未来事件或结果不确定性的词语来识别这些前瞻性陈述。

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.

特别是，公司关于趋势和潜在未来结果的声明就是此类前瞻性声明的例子。前瞻性陈述包括风险和不确定性，包括但不限于公司Sunosi®、Auvelity®和Symbravo®产品的商业成功，以及公司努力获得有关solriamfetol和/或AXS-05的任何其他指示的成功；公司维持和扩大付款人覆盖范围的能力；公司正在进行的临床试验和公司当前候选产品的预期临床试验的成功率、时间和成本，包括关于开始时间、注册速度和完成试验的声明（包括公司完全资助公司披露的临床试验的能力，假设公司目前预计的收入或费用没有实质性变化），无效分析和中期结果的接收，这些不一定表明公司正在进行的临床试验的最终结果，和/或数据读数，以及支持公司当前候选产品提交新药申请（“NDA”）所需的研究数量或类型或结果的性质；公司有能力资助额外的临床试验，以继续推进公司的候选产品；的。

U.S. Food and Drug Administration

U、 美国食品和药物管理局

(“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 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.

（“FDA”）或其他监管机构对公司候选产品的批准或其他行动，包括关于任何NDA提交时间的声明；公司成功保护其知识产权或以公司可接受的成本获得必要许可（如果有的话）的能力；公司研发计划和合作的成功实施；公司许可协议的成功；公司产品和候选产品（如经批准）的市场接受程度；公司的预期资本要求，包括Sunosi、Auvelity和Symbravo商业化所需的资本金额，以及公司商业推出其他候选产品所需的资本金额（如果获得批准），以及对公司预期现金跑道的潜在影响；公司将销售额转换为已确认收入并保持有利的总销售额与净销售额的能力；国内政治气候、地缘政治冲突或全球流行病以及其他不在公司控制范围内的因素（包括一般经济状况和监管发展）引起或与之相关的不可预见的情况或正常业务运营的其他中断。

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 circumstance..

本文讨论的因素可能导致实际结果和发展与此类声明中表达或暗示的结果和发展存在实质性差异。前瞻性声明仅在本新闻稿发布之日做出，公司没有义务公开更新此类前瞻性声明以反映后续事件或情况。。

Investors:

投资者：

Mark Jacobson

马克·雅各布森

Chief Operating Officer

首席运营官

(212) 332-3243

(212) 332-3243

mjacobson@axsome.com

mjacobson@axsome.com

Media:

媒体：

Darren Opland

达伦 Opland

Director, Corporate Communications

企业传播总监

(929) 837-1065

(929) 837-1065

dopland@axsome.com

dopland@axsome.com

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.

.

New York, NY

纽约州纽约市

.

.

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头痛分类委员会

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Lipton RB, Stewart WF. Acute migraine therapy: do doctors understand what patients with migraine want from therapy? Headache. 1999;39(suppl 2):S20-S26.

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Lipton RB, Munjal S et al. Unmet Acute Treatment Needs From the 2017 Migraine in America Symptoms and Treatment Study. Headache. 2019 Sep;59(8):1310-1323. doi: 10.1111/head.13588

Lipton RB，Munjal S等人。2017年美国偏头痛症状和治疗研究未满足的急性治疗需求。头痛。2019年9月；59（8）：1310-1323年。doi:10.1111/head.13588

Source: Axsome Therapeutics, Inc.

来源：Axsome Therapeutics，Inc。