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SYMBRAVO represents a novel multi-mechanistic approach to treating migraine that addresses multiple pathways underlying a migraine attack

SYMBRAVO 代表了一种治疗偏头痛的新型多机制方法，能够针对偏头痛发作的多种途径。

SYMBRAVO On My Side offers comprehensive patient support services including access and prescription drug support

SYMBRAVO 在我这边提供全面的患者支持服务，包括获取和处方药支持。

NEW YORK

纽约

,

，

June 10, 2025

2025年6月10日

(GLOBE NEWSWIRE) --

（环球新闻社）——

Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc.

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

(NASDAQ: 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 SYMBRAVO

®

®

(meloxicam and rizatriptan) is now available by prescription in

（美洛昔康和利扎曲普坦）现在可凭处方购买

the United States

美国

for the acute treatment of migraine with or without aura in adults.

用于成人有或无先兆的偏头痛的急性治疗。

1

1

SYMBRAVO represents a novel multi-mechanistic approach to treating migraine that targets multiple brain pathways underlying a migraine attack. SYMBRAVO rapidly provides migraine pain freedom and returns patients to normal functioning at 2 hours versus placebo, with lasting pain freedom sustained from 2 to 24 hours in some patients after a single dose..

SYMBRAVO 代表了一种治疗偏头痛的新型多机制方法，靶向偏头痛发作背后的多个大脑通路。SYMBRAVO 能够快速缓解偏头痛疼痛，并在两小时内使患者恢复正常功能，而与安慰剂相比，部分患者在单次给药后可以持续维持从2小时到24小时的持久疼痛缓解。

Stewart J. Tepper

斯图尔特·J·特珀

, MD, Vice President of

医学博士，副总裁

The New England Institute for Neurology and Headache

新英格兰神经病学和头痛研究所

, said, “Many individuals living with migraine do not achieve adequate pain relief with currently available acute treatments. SYMBRAVO therefore provides a potentially valuable new treatment option as a rapid-acting and durable multi-mechanistic approach. Taken together with the demonstrated data showing effectiveness across a spectrum of migraine severities, I believe that SYMBRAVO offers potentially significant clinical benefits for patients, especially those reporting inadequate relief from migraine pain with their existing treatment program.”.

“许多偏头痛患者使用目前可用的急性治疗药物无法获得充分的疼痛缓解。因此，SYMBRAVO 提供了一种潜在的、有价值的全新治疗选择，具有快速起效和持久的多机制作用。结合已证明的数据，显示出其在不同程度的偏头痛中均有效，我相信 SYMBRAVO 为患者提供了潜在的重要临床益处，特别是那些现有治疗方案未能充分缓解偏头痛疼痛的患者。”

Susan Lane Stone

苏珊·莱恩·斯通

, MBA, CEO of the

，工商管理硕士，首席执行官

National Headache Foundation

全国头痛基金会

(NHF), commented, “The National Headache Foundation educational and advocacy programs encourage the over 40 million Americans (including 31.5 million women and 6.7 million members of the military community) to speak up about their own unique acute migraine journey. Many are still seeking solutions, as they have not yet found relief, so having a new FDA-approved option for the acute treatment of migraine will help address this significant unmet need.

全国头痛基金会 (NHF) 评论道：“全国头痛基金会的教育和倡导项目鼓励超过4000万美国人（包括3150万女性和670万军人社区成员）说出自己独特的急性偏头痛经历。许多人仍在寻找解决方案，因为他们尚未找到缓解方法，因此拥有一个新的FDA批准的急性偏头痛治疗选择将有助于满足这一重要的未满足需求。

For over 50 years, the NHF has been a credible resource for the headache and migraine disorders community. NHF’s awareness and educational initiatives have focused on the recognition that head pain and other bothersome symptoms are very real daily challenges for each person living with migraine attacks.”.

五十多年来，NHF 一直是头痛和偏头痛疾病社区的可靠资源。NHF 的意识提升和教育举措侧重于认识到头部疼痛和其他烦人症状是每位经历偏头痛发作患者每天面临的真正挑战。"

Ari Maizel

阿里·梅泽尔

, Chief Commercial Officer of Axsome, added, “We are very pleased to launch SYMBRAVO, powered by Axsome’s patented MoSEIC™ technology, and deliver a novel therapy to the millions of people living with migraine. At Axsome, we are intensely committed to improving the lives of patients. To ensure patient access to this important and distinct medicine, we are also providing comprehensive patient support, which includes a SYMBRAVO On My Side savings program for eligible patients as well as educational resources and tools.”.

Axsome的首席商务官补充道：“我们非常高兴推出由Axsome专利MoSEIC™技术支持的SYMBRAVO，为数百万偏头痛患者带来一种全新的疗法。在Axsome，我们全力以赴致力于改善患者的生活。为了确保患者能够获得这种重要且独特的药物，我们还提供全面的患者支持，其中包括为符合条件的患者提供SYMBRAVO On My Side储蓄计划，以及教育资料和工具。”

Migraine is a debilitating condition characterized by recurrent attacks of pulsating, often severe and disabling head pain, accompanied by nausea, sensitivity to light, and/or sensitivity to sound.

偏头痛是一种令人衰弱的疾病，其特征是反复发作的搏动性、通常为严重且致残的头痛，伴有恶心、对光敏感和/或对声音敏感。

2

2

Migraine affects approximately 40 million people in the

偏头痛影响着大约4000万人

U.S.

美国

and according to the Global Burden of Disease study in 2019, is the second leading cause of all disability worldwide.

根据2019年全球疾病负担研究，是全球所有残疾的第二大原因。

3,4

3，4

A recent survey of more than 1700 migraine patients showed that 63% were not satisfied with their current treatment plan.

最近一项针对1700多名偏头痛患者的调查显示，63%的患者对其目前的治疗方案不满意。

5

5

Resources for Patients and

患者资源和

Healthcare Providers

医疗服务提供者

For patients, Axsome provides robust and comprehensive support services through the Symbravo On My Side program. The Company’s Symbravo On My Side Savings Card reduces patient out-of-pocket costs for commercially insured eligible patients who qualify. Axsome’s Symbravo On My Side program provides patients with educational resources and tools for patients to facilitate discussions with their healthcare providers.

对于患者，Axsome通过Symbravo On My Side计划提供强大而全面的支持服务。公司的Symbravo On My Side储蓄卡降低了符合条件的商业保险患者的自付费用。Axsome的Symbravo On My Side计划为患者提供教育资源和工具，以帮助他们与医疗服务提供者进行交流。

More information on the patient programs and services can be found at .

有关患者项目和服务的更多信息，请访问。

symbravo.com

symbravo.com

.

。

About SYMBRAVO

关于SYMBRAVO

SYMBRAVO (meloxicam and rizatriptan, 20 mg/10mg tablets) 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（美洛昔康和利扎曲普坦，20毫克/10毫克片剂）是一种新型的、口服的、单剂量药物，获准用于成人偏头痛（有或无先兆）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 技术实现的用于偏头痛的新分子实体。

Molecular Solubility Enhanced Inclusion Complex

分子溶解度增强包合物

) 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

）技术，该技术使得美洛昔康能够快速吸收，同时保持较长的血浆半衰期。美洛昔康是一种优先作用于COX-2的非甾体抗炎药（NSAID），而利扎曲普坦是一种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.

激动剂。SYMBRAVO 旨在提供快速、增强和一致的偏头痛疼痛缓解，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

欲了解更多信息，请访问

www.symbravo.com

www.symbravo.com

.

。

INDICATION AND IMPORTANT SAFETY INFORMATION

适应症和重要安全信息

What is SYMBRAVO (sim-BRAH-voh)? SYMBRAVO is a combination of meloxicam (an NSAID) and rizatriptan (a triptan).

什么是SYMBRAVO（sim-BRAH-voh）？SYMBRAVO是美洛昔康（一种非甾体抗炎药）和利扎曲坦（一种曲普坦类药物）的组合。

SYMBRAVO is an oral prescription medicine used to treat acute migraine headaches with or without aura in adults.

SYMBRAVO 是一种口服处方药，用于治疗成人有或无先兆的急性偏头痛。

SYMBRAVO is not used to prevent or decrease the number of migraine headaches you have or for treatment of hemiplegic or basilar migraines. SYMBRAVO is not indicated as a treatment for cluster headaches or for use in children.

SYMBRAVO 不用于预防或减少您偏头痛的次数，也不用于治疗偏瘫性或基底型偏头痛。SYMBRAVO 不适用于丛集性头痛的治疗，也不适用于儿童。

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SYMBRAVO?

我应该了解的关于SYMBRAVO的最重要的信息是什么？

SYMBRAVO may increase the risk of a heart attack or stroke that can lead to death.

SYMBRAVO 可能会增加心脏病发作或中风的风险，严重时可导致死亡。

This risk may happen early in treatment and may increase with increasing doses, and longer use, of NSAIDs.

这种风险可能在治疗早期出现，并且随着NSAIDs剂量的增加和使用时间的延长而增加。

Do not take SYMBRAVO right before or after a heart surgery called a “coronary artery bypass graft” (CABG).

在称为“冠状动脉搭桥术”（CABG）的心脏手术前后，请勿立即服用SYMBRAVO。

Avoid taking SYMBRAVO after a recent heart attack unless your healthcare provider (HCP) tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

除非您的医疗保健提供者 (HCP) 告诉您，否则请避免在近期心脏病发作后服用 SYMBRAVO。如果您在近期心脏病发作后服用非甾体抗炎药 (NSAIDs)，可能会面临再次心脏病发作的较高风险。

Stop taking SYMBRAVO and get emergency help right away if you have any of the following symptoms which can be indicative of a heart attack or stroke:

如果您出现以下任何可能表明心脏病发作或中风的症状，请立即停止服用SYMBRAVO并马上获得紧急帮助：

discomfort in your chest that lasts for more than a few minutes, or that goes away and comes back

胸部不适持续几分钟以上，或者消失后又回来

severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw

胸部、喉咙、颈部或下巴出现严重的紧绷感、疼痛、压迫感或沉重感

pain or discomfort in your arms, back, neck, jaw, or stomach

手臂、背部、颈部、下巴或胃部疼痛或不适

shortness of breath with or without chest discomfort

有或无胸部不适的呼吸急促

breaking out in a cold sweat

冷汗直冒

nausea or vomiting

恶心或呕吐

feeling lightheaded

感到头晕目眩

weakness in one part or one side of your body

身体某一部分或一侧的虚弱

slurred speech

含糊不清的言语

People with risk factors for heart disease should not take SYMBRAVO unless a heart exam is done and shows no problem. You have higher risk for heart disease if you:

有心脏病风险因素的人不应服用SYMBRAVO，除非经过心脏检查且结果显示无问题。如果您符合以下情况，则患心脏病的风险较高：

have high blood pressure

有高血压

have high cholesterol

胆固醇高

smoke

烟雾

are overweight

超重

have diabetes or a family history of diabetes

有糖尿病或糖尿病家族史

SYMBRAVO can increase the risk of potentially life-threatening bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines that can occur anytime during use and without warning symptoms.

SYMBRAVO 可能增加食管（从口腔到胃的管道）、胃和肠道在使用期间随时可能发生且无预警症状的潜在致命性出血、溃疡和穿孔的风险。

SYMBRAVO may cause serious allergic or skin reactions which can be life-threatening.

SYMBRAVO 可能引起严重的过敏或皮肤反应，这些反应可能危及生命。

Stop taking SYMBRAVO and get emergency help right away if you develop:

如果出现以下情况，请立即停止服用SYMBRAVO并寻求紧急帮助：

sudden wheezing or problems breathing or swallowing

突然喘息或呼吸或吞咽困难

rash or reddening of your skin with blisters or peeling

皮疹或皮肤红肿，伴有水泡或脱皮

blisters or bleeding of your lips, eye lids, mouth, nose, or genitals

嘴唇、眼睑、口腔、鼻子或生殖器出现水泡或出血

swelling of your lips, tongue, throat or body

嘴唇、舌头、喉咙或身体肿胀

fainting

昏厥

SYMBRAVO already contains an NSAID (meloxicam). Do not

SYMBRAVO 已含有非甾体抗炎药（美洛昔康）。请勿

use SYMBRAVO with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your HCP first, because they may contain an NSAID also.

在未先咨询您的医疗保健提供者（HCP）之前，不要将SYMBRAVO与其他药物一起使用以减轻疼痛或发烧，或与用于感冒或睡眠问题的其他药物一起使用，因为它们也可能含有非甾体抗炎药（NSAID）。

Do not take SYMBRAVO if you:

如果您：请勿服用SYMBRAVO。

have or had heart problems or right before or after heart bypass surgery

有或曾有心脏问题，或在心脏搭桥手术之前或之后

have or had a stroke or transient ischemic attack (TIA)

有或曾经有中风或短暂性脑缺血发作（TIA）

have or had blood vessel problems of your legs and arms, stomach (ischemic bowel disease), or kidneys

有或曾有腿部和手臂、胃部（缺血性肠病）或肾脏的血管问题

have or had hemiplegic or basilar migraines

有或曾经有偏瘫性或基底型偏头痛

have uncontrolled high blood pressure

患有不受控制的高血压

take propranolol containing medicines

服用含普萘洛尔的药物

have taken other triptan or ergot-containing medicines within the last 24 hours

在过去24小时内服用过其他含有曲普坦或麦角的药物

take an antidepressant medicine called monoamine oxidase inhibitor (MAOI) or have taken a MAOI within the last 2 weeks

服用一种叫做单胺氧化酶抑制剂（MAOI）的抗抑郁药物，或在过去两周内服用过MAOI

are allergic to meloxicam, rizatriptan, NSAIDs, or any of the ingredients in SYMBRAVO

对美洛昔康、利扎曲普坦、非甾体抗炎药或SYMBRAVO中的任何成分过敏

have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs

服用阿司匹林或任何其他非甾体抗炎药后出现哮喘发作、荨麻疹或其他过敏反应

have moderate to severe kidney problems and are at risk of kidney failure or if you are on dialysis

有中度至重度的肾脏问题，并且有肾衰竭的风险，或者您正在接受透析治疗

SYMBRAVO may cause serious side effects. These serious side effects include:

SYMBRAVO 可能导致严重的副作用。这些严重的副作用包括：

heartbeats that are too fast or too slow (arrhythmias)

心跳过快或过慢（心律失常）

new or worse high blood pressure

新的或更严重的高血压

heart failure

心力衰竭

life-threatening skin reactions

危及生命的皮肤反应

liver or kidney problems including organ failure

肝脏或肾脏问题，包括器官衰竭

low red blood cell count (anemia)

低红细胞计数（贫血）

asthma attacks in people who have asthma

哮喘患者哮喘发作

Medication Overuse Headaches:

药物过度使用性头痛：

Some people who use too many SYMBRAVO tablets may have worse headaches. If your headaches get worse, your HCP may decide to stop your treatment with SYMBRAVO.

一些使用过多SYMBRAVO药片的人可能会出现更严重的头痛。如果你的头痛加重，你的医疗保健提供者（HCP）可能会决定停止使用SYMBRAVO进行治疗。

Stop taking SYMBRAVO and get emergency help right away if you have any of the following:

如果出现以下任何情况，请立即停止服用SYMBRAVO并寻求紧急帮助：

Stomach and intestinal problems.

胃肠道问题。

Symptoms of gastrointestinal and colonic ischemic events may include sudden or severe stomach pains even after meals; sudden weight loss; severe nausea, vomiting, constipation, diarrhea; and bloody diarrhea.

胃肠道和结肠缺血事件的症状可能包括：即使在餐后突然或严重的胃痛、突然的体重减轻、严重的恶心、呕吐、便秘、腹泻以及血性腹泻。

Circulation problems to legs and feet.

腿部和脚部的循环问题。

Symptoms of peripheral vascular ischemia may include cramping and pain in your legs and hips; heaviness or tightness in leg muscles; burning, aching, numbness, tingling, or weakness in your legs, feet, or toes; cold feelings or color changes in one or both legs or feet.

外周血管缺血的症状可能包括腿部和臀部的痉挛和疼痛；腿部肌肉的沉重感或紧绷感；腿部、脚部或脚趾的灼烧感、酸痛、麻木、刺痛或无力；一条腿或双脚的冰冷感或颜色变化。

Serotonin syndrome.

血清素综合征。

Can happen when taking SYMBRAVO with antidepressant medicines called SSRIs or SNRIs. Stop taking SYMBRAVO and call your doctor right away if you have any of the following symptoms:

与称为SSRIs或SNRIs的抗抑郁药物一起服用SYMBRAVO时可能会发生。如果您有以下任何症状，请立即停止服用SYMBRAVO并马上联系您的医生：

mental status changes including agitation, hallucinations, or coma

精神状态改变，包括躁动、幻觉或昏迷

fast heartbeat

心跳加速

changes in your blood pressure

血压变化

increased body temperature

体温升高

tight muscles

紧绷的肌肉

trouble walking

行走困难

Stop taking SYMBRAVO and call your healthcare provider right away if you have any of the following symptoms:

如果出现以下任何症状，请立即停止服用SYMBRAVO并联系您的医疗保健提供者：

nausea

恶心

vomiting blood

呕血

more tired or weaker than usual

比平时更累或更虚弱

blood in your bowel movement or it is black and sticky like tar

你的大便带血或呈黑色且粘稠如沥青

diarrhea

腹泻

itching, skin rash, or blisters with fever

瘙痒、皮疹或伴有发烧的水疱

unusual weight gain

异常体重增加

your skin or eyes look yellow

你的皮肤或眼睛看起来发黄

indigestion or stomach pain

消化不良或胃痛

swelling of the arms, legs, hands, or feet

手臂、腿、手或脚的肿胀

flu-like symptoms

流感样症状

tenderness in your right upper side

右上腹部的压痛感

vision problems

视力问题

COMMON SIDE EFFECTS

常见副作用

The most common side effects of SYMBRAVO include

SYMBRAVO最常见的副作用包括

dizziness and tiredness.

头晕和疲倦。

These are not all the possible side effects of SYMBRAVO. Tell your doctor if you have any side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit

这些并非 SYMBRAVO 的所有可能副作用。如果有任何副作用，请告诉您的医生。我们鼓励您向 FDA 报告处方药的副作用。访问

www.fda.gov/medwatch

www.fda.gov/medwatch

, or call 1–800-FDA-1088.

，或者拨打1-800-FDA-1088。

BEFORE USING

使用前

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

告诉您的医疗保健提供者您服用的所有药物，包括处方药和非处方药、维生素以及草本补充剂。

It is important to tell your HCP if you are taking:

如果您正在服用以下药物，请务必告诉您的医疗保健提供者 (HCP)：

Propranolol containing medicines such as Inderal® LA or Innopran® XL

含有普萘洛尔的药物，如Inderal® LA或Innopran® XL

Aspirin or other anti-coagulants (blood thinners)

阿司匹林或其他抗凝剂（血液稀释剂）

Medicines to help your mood including SSRIs and SNRIs

有助于改善情绪的药物，包括选择性5-羟色胺再摄取抑制剂（SSRIs）和5-羟色胺-去甲肾上腺素再摄取抑制剂（SNRIs）。

If you are unsure if you take any of these medicines, ask your HCP. They can tell you if it is safe to take SYMBRAVO with your other medicines.

如果您不确定是否服用这些药物，请咨询您的医疗保健提供者。他们可以告诉您与其他药物一起服用SYMBRAVO是否安全。

Tell your HCP if you are pregnant or plan to become pregnant. SYMBRAVO is not recommended during pregnancy. Taking NSAIDs, including SYMBRAVO, at about 20 weeks of pregnancy or later may harm your unborn baby.

告诉您的医疗保健提供者您是否怀孕或计划怀孕。SYMBRAVO不建议在怀孕期间使用。在怀孕约20周或之后服用NSAIDs（包括SYMBRAVO）可能会对您的未出生婴儿造成伤害。

NSAIDs, including SYMBRAVO, should not be taken after about 30 weeks of pregnancy.

NSAIDs，包括SYMBRAVO，不应在怀孕约30周后服用。

Tell your HCP if you are breastfeeding or plan to breastfeed.

告诉您的医疗保健提供者您是否正在哺乳或计划哺乳。

Tell your HCP about all your medical conditions, including if you:

告诉您的医疗保健提供者 (HCP) 您的所有健康状况，包括如果您：

have or have had heart problems, high blood pressure, chest pain, or shortness of breath

有或曾经有心脏问题、高血压、胸痛或呼吸急促症状

have any risk factors for heart or blood vessel problems

有心脏或血管问题的风险因素

have kidney or liver problems

有肾或肝问题

have asthma

患有哮喘

Review the list below with your HCP. SYMBRAVO may not be right for you if:

请与您的医疗保健提供者（HCP）一起查看以下列表。如果您有以下情况，SYMBRAVO可能不适合您：

take daily preventative aspirin

每天服用预防性阿司匹林

you are pregnant or plan to become pregnant

您怀孕或计划怀孕

you are breastfeeding or plan to breastfeed

您正在哺乳或计划进行哺乳

HOW TO TAKE

如何服用

SYMBRAVO is available by prescription only.

SYMBRAVO 仅可凭处方获得。

Take SYMBRAVO exactly as instructed by your HCP.

请严格按照您的医疗保健专业人员（HCP）的指示服用SYMBRAVO。

The maximum daily dose of SYMBRAVO is 1 tablet. Talk to your HCP about what to do if your headache does not go away or comes back.

SYMBRAVO 的最大日剂量为 1 片。如果头痛未消退或复发，请咨询您的医疗保健提供者应采取的措施。

Take SYMBRAVO for the shortest time needed.

按所需最短时间服用SYMBRAVO。

Swallow SYMBRAVO tablets whole.

整粒吞服SYMBRAVO药片。

Do not

不要

crush, chew, or divide the tablets.

压碎、咀嚼或分割药片。

SYMBRAVO can be taken with or without food.

SYMBRAVO 可以随餐或不随餐服用。

Do not give SYMBRAVO to other people.

请勿将SYMBRAVO给予他人。

If you take too much SYMBRAVO call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

如果您服用过多的SYMBRAVO，请立即拨打1-800-222-1222联系毒物控制中心或前往最近的医院急诊室。

LEARN MORE

了解更多

For more information about SYMBRAVO, call 866-496-2976 or visit

有关SYMBRAVO的更多信息，请拨打866-496-2976或访问

SYMBRAVO.com

SYMBRAVO.com

.

。

This summary provides basic information about SYMBRAVO but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about SYMBRAVO and how to take it.

本摘要提供了有关SYMBRAVO的基本信息，但并未包含有关此药物的所有信息。每次填写处方时，请阅读随附的处方信息。此信息不能代替与医生的交流。务必与您的医生或其他医疗保健专业人员讨论SYMBRAVO及其使用方法。

Your HCP is the best person to help you decide if SYMBRAVO is right for you..

您的医疗保健专业人士 (HCP) 是帮助您决定 SYMBRAVO 是否适合您的最佳人选。

SYM CON BS 01/2025

对称连接标准 01/2025

Please see full

请查看完整内容

Prescribing Information

处方信息

, including Boxed Warning for risk of serious cardiovascular and gastrointestinal adverse events, and

，包括严重心血管和胃肠道不良事件风险的加框警告，以及

Medication Guide

药品指南

.

。

About

关于

Axsome Therapeutics

Axsome Therapeutics

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.

是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。我们通过识别护理中的关键差距，开发具有新颖作用机制的差异化产品，从而实现科学突破，为患者带来有意义的疗效提升。

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

我们行业领先的神经科学产品组合包括FDA批准的用于治疗重度抑郁症、与嗜睡症和阻塞性睡眠呼吸暂停相关的过度日间嗜睡以及偏头痛的疗法，并且还有多个针对广泛严重神经和精神疾病的晚期开发项目，这些疾病影响着超过1.5亿人。

the 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 us at

。我们共同肩负着解决大脑一些最大问题的使命，让患者及其亲人能够茁壮成长。欲了解更多信息，请访问我们的网站

www.axsome.com

www.axsome.com

and follow us on

并关注我们

LinkedIn

领英

and

和

X

X

.

。

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属于“前瞻性陈述”。公司可能会在某些情况下使用诸如“预测”、“相信”、“潜在”、“继续”、“估计”、“预期”、“计划”、“打算”、“可能”、“能够”、“也许”、“将”、“应该”等词语，或传达未来事件或结果不确定性的其他措辞来标识这些前瞻性陈述。

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.

特别是，公司关于趋势和潜在未来结果的声明是此类前瞻性陈述的例子。前瞻性声明包括风险和不确定性，包括但不限于公司SUNOSI的商业成功。

®

®

, AUVELITY

，AUVELITY

®

®

, and SYMBRAVO

，以及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 .

产品以及公司为solriamfetol和/或AXS-05获得任何额外适应症的努力的成功；公司维持和扩大支付方覆盖的能力；公司正在进行的临床试验及预期临床试验的成功、时间安排和成本，针对公司当前的候选产品，包括关于试验启动时间、入组速度和完成情况的声明（包括公司完全资助其已披露临床试验的能力，该假设基于公司目前预计的收入或支出无重大变化），无效性分析及中期结果的接收，这些结果不一定代表公司正在进行的临床试验的最终结果，和/或数据读出，以及支持公司当前任何候选产品新药申请（“NDA”）所需的研究数量或类型或结果性质；公司为继续推进其候选产品而资助额外临床试验的能力；公司获得和维持的时间和能力。

U.S. Food and Drug Administration

美国食品药品监督管理局

(“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 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.

（“FDA”）或其他监管机构对本公司产品候选者的批准，或对其采取的其他行动，包括有关任何新药申请（NDA）提交时间的声明；公司成功捍卫其知识产权或以公司可接受的成本获得必要许可的能力（如果可以的话）；公司成功解决任何知识产权诉讼的能力，即使这些争议得以解决，相关联邦机构是否会批准此类和解；公司研究与开发计划及合作的成功实施；公司许可协议的成功；市场对公司产品及其候选产品的接受程度（如获批准）；公司预期的资本需求，包括用于商业化SUNOSI、AUVELITY和SYMBRAVO以及公司其他候选产品商业发布所需的资本金额（如获批准），及其对公司预期现金跑道的潜在影响；公司将销售转化为确认收入并保持有利的总销售额至净销售额比率的能力；由于国内政治气候、地缘政治冲突或全球疫情引起的正常业务运营中断或其他不可预见情况，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。

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 sta.

本文讨论的因素可能导致实际结果和发展与这些陈述中表达或暗示的内容存在重大差异。前瞻性陈述仅在本新闻稿发布之日作出，公司不承担公开更新此类前瞻性陈述的义务。

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·奥普兰德

Director, Corporate Communications

企业传播总监

(929) 837-1065

(929) 837-1065

dopland@axsome.com

dopland@axsome.com

References:

参考文献：

SYMBRAVO [Prescribing Information].

SYMBRAVO [处方信息]。

New York, NY

纽约州，纽约市

;

；

Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc.

Headache Classification Committee

头痛分类委员会

of the

的

International Headache Society (IHS) Cephalagia

国际头痛协会（IHS）《头痛》

(2018)

（2018）

American Migraine Foundation

美国偏头痛基金会

(2023),

（2023），

https://americanmigrainefoundation.org/

https://americanmigrainefoundation.org/

, accessed

，访问

May 2, 2025

2025年5月2日

.

。

Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020

施泰纳 TJ，斯托夫纳 LJ，詹森 R，乌卢祖兹 D，卡萨拉瓦 Z。偏头痛仍然是全球致残原因的第二位，也是年轻女性的首要原因：GBD2019 的研究结果。《头痛与疼痛杂志》。2020年。

Dec 2

12月2日

;21(1):137.

;21(1):137.

Morton, BA, Brooks, CV, Lenaburg, KJ, Buzby, MA, Lipton, RB and DC Buse.

莫顿，文学学士，布鲁克斯，CV，勒纳堡，KJ，布兹比，MA，利普顿，RB 和 DC 布斯。

Coalition for Headache and Migraine Patient

头痛和偏头痛患者联盟

: Headache Disease Patient Access Survey Brief 2. (2020).

头痛疾病患者获取调查简报 2. (2020).

Source: Axsome Therapeutics, Inc.

来源：Axsome Therapeutics, Inc.