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Late-breaking oral presentation of results from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation

AXS-05在阿尔茨海默病躁动的阳性关键ACCORD-2 3期试验结果的最新口头报告

Presentation featuring network meta-analysis of SYMBRAVO

展示包含SYMBRAVO的网络荟萃分析

®

®

versus oral CGRPs

对比口服CGRP

NEW YORK

纽约

,

，

April 04, 2025

2025年4月4日

(GLOBE NEWSWIRE) --

（环球新闻网）--

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 multiple presentations spanning its innovative, industry-leading psychiatry and neurology portfolio at the 2025

(NASDAQ: AXSM)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，今天宣布在2025年会议上展示其创新且行业领先的精神病学和神经学产品组合相关的多项报告。

American Academy of Neurology

美国神经病学学会

(AAN) Annual Meeting, being held

(AAN)年会，正在举行

April 5-9

4月5日至9日

in

在

San Diego, California

加利福尼亚州圣迭戈

.

。

Oral and poster presentations include data from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer’s disease (AD) agitation, accepted as a late-breaking abstract, and from the positive pivotal SYMPHONY Phase 3 trial of AXS-12 in narcolepsy. Additional data being presented includes a network meta-analysis comparing the efficacy of SYMBRAVO.

口头和海报展示包括来自AXS-05在阿尔茨海默病（AD）激越症的阳性关键性ACCORD-2第三阶段试验的数据，该数据已被接受为最新突破性摘要；还包括AXS-12在嗜睡症的阳性关键性SYMPHONY第三阶段试验的数据。正在展示的其他数据包括比较SYMBRAVO疗效的网络荟萃分析。

®

®

(AXS-07) to oral CGRPs in the acute treatment of migraine.

(AXS-07) 用于偏头痛急性治疗中的口服CGRP。

Details for the presentations are as follows:

演示文稿的详细信息如下：

Alzheimer’s Disease Agitation

阿尔茨海默病躁动

Title

标题

: Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: A Phase 3 Randomized Withdrawal Double-Blind Placebo-Controlled Study

AXS-05治疗阿尔茨海默病躁动的疗效与安全性：一项三期随机撤药双盲安慰剂对照研究

Oral Presentation Date and Time:

口头报告日期和时间：

Monday, April 7

4月7日，星期一

,

，

11:27 - 11:33 a.m. PT

上午11点27分至11点33分（太平洋时间）

Poster Presentation Date and Time:

海报展示日期和时间：

Monday, April 7

4月7日，星期一

,

，

12:09 - 12:45 p.m. PT

12:09 - 12:45 下午（太平洋时间）

Session

会话

Name

名称

:

：

Late-breaking Science 1

晚期突破科学 1

Poster Number:

海报编号：

3

3

Abstract:

摘要：

246

246

Narcolepsy

嗜睡症

Title:

标题：

AXS-12 for the Treatment of Narcolepsy: Topline Results from the Phase 3 SYMPHONY Trial

AXS-12治疗嗜睡症：3期SYMPHONY试验的初步结果

Oral Presentation Date and Time:

口头报告日期和时间：

Tuesday, April 8

4月8日，星期二

,

，

10:45 - 11 a.m. PT

10:45 - 11 a.m. 太平洋时间

Lead Author:

主要作者：

Michael J. Thorpy

迈克尔·J·索普

, MD, Director of the Sleep-Wake Disorders Center at the

医学博士，睡眠-觉醒障碍中心主任

Montefiore Medical Center

蒙特菲奥里医疗中心

and Professor of Neurology at

神经病学教授

Albert Einstein College of Medicine

阿尔伯特·爱因斯坦医学院

,

，

New York, NY

纽约，纽约州

Session

会话

Name

名称

:

：

Clinical Trials Plenary Session

临床试验全体会议

Program Number:

程序编号：

PL5

PL5

Title:

标题：

CRESCENDO: Results from a Survey of Symptom Burden and Quality of Life in Patients with Narcolepsy Type 1

CRESCENDO：1型嗜睡症患者症状负担和生活质量调查结果

Poster Presentation Date and Time:

海报展示日期和时间：

Tuesday, April 8

4月8日，星期二

,

，

8 - 9 a.m. PT

上午8点到9点（太平洋时间）

Lead Author:

主要作者：

Michael J. Thorpy

迈克尔·J·索普?

, MD, Director of the Sleep-Wake Disorders Center at the

医学博士，睡眠-觉醒障碍中心主任

Montefiore Medical Center

蒙特菲奥里医疗中心

and Professor of Neurology at

神经病学教授

Albert Einstein College of Medicine

阿尔伯特·爱因斯坦医学院

,

，

New York, NY

纽约州，纽约市

Session

会话

Name

名称

:

：

Sleep 2

睡眠 2

Program Number:

程序编号：

P8:001

P8:001

Migraine

偏头痛

Title:

标题：

Comparative Efficacy of AXS-07 vs. Gepants for Acute Treatment of Migraine: A Network Meta-Analysis

急性偏头痛治疗中AXS-07与Gepants的比较疗效：一项网络荟萃分析

Poster Presentation Date and Time:

海报展示日期和时间：

Tuesday, April 8, 5 - 6 p.m. PT

4月8日星期二，下午5点至6点（太平洋时间）

Lead Author:

主要作者：

Stephanie Nahas

斯蒂芬妮·纳哈斯

, MD, Associate Professor of Neurology at the

医学博士，神经病学副教授

Thomas Jefferson University Hospitals-Jefferson Health Center

托马斯·杰斐逊大学医院-杰斐逊健康中心

,

，

Philadelphia, PA

宾夕法尼亚州费城

Session

会话

Name

名字

:

：

Headache: Advances in CGRP Inhibitors and Migraine 3

头痛：CGRP抑制剂和偏头痛的进展 3

Program Number:

程序编号：

P10.006

P10.006

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 是一种新型的、口服的、单剂量药物，获准用于成人有或无先兆的急性偏头痛治疗。SYMBRAVO 包含 MoSEIC™ 美洛昔康和利扎曲普坦。美洛昔康是一种由 Axsome 的 MoSEIC 技术实现的全新分子实体，专用于偏头痛治疗。

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，可以快速吸收美洛昔康，同时保持较长的血浆半衰期。美洛昔康是一种优先抑制COX-2的非甾体抗炎药（NSAID），而利扎曲坦是一种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

适应症和重要的安全信息

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）和利扎曲普坦（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“冠状动脉旁路移植术”（CABG）的心脏手术之前或之后，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)，可能会有再次心脏病发作的风险。

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，或者消失后又再次出现

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

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紧绷感、疼痛、压迫感或沉重感

weakness in one part or one side of your body

身体某一部分或一侧的虚弱

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

手臂、背部、颈部、下巴或胃部感到疼痛或不适

slurred speech

含糊不清的言语

shortness of breath with or without chest discomfort

有或无胸闷的呼吸急促

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，除非进行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

smoke

烟雾

have high cholesterol

胆固醇高

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 会增加食管（从口腔到胃的管道）、胃和肠道在使用期间随时可能出现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并马上寻求紧急帮助：

sudden wheezing or problems breathing or swallowing

突然喘息或呼吸或吞咽困难

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

嘴唇、眼皮、口腔、鼻子或生殖器出现水泡或出血

rash or reddening of your skin with blisters or peeling

皮疹或皮肤发红，伴有水泡或脱皮

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，请勿将SYMBRAVO与其他药物一起使用以减轻疼痛或发烧，或与其他用于感冒或睡眠问题的药物一起使用，因为它们可能也含有非甾体抗炎药（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，或在心脏搭桥手术前后

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）

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。

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

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 or had hemiplegic or basilar migraines

有或曾有偏瘫性或基底型偏头痛

have uncontrolled high blood pressure

患有无法控制的高血压

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

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小时内已服用其他含曲普坦或麦角的药物

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

患有中度至重度肾脏问题，有肾衰竭风险或正在接受透析的患者

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）

liver or kidney problems including organ failure

肝或肾问题，包括器官衰竭

new or worse high blood pressure

新的或更严重高血压

low red blood cell count (anemia)

低红细胞计数（贫血）

heart failure

心力衰竭

life-threatening skin reactions

危及生命的皮肤反应

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、腹泻以及血便。

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

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

不寻常的体重增加

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

你右上侧的压痛感

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、维生素和草药补充剂。

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

如果您正在服用以下药物，告知您的医疗保健专业人员非常重要：

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

含普萘洛尔的药物，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

帮助改善情绪的药物，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中的任何一种，请咨询您的医疗保健提供者。他们可以告诉您是否可以安全地将SYMBRAVO与您的其他药物一起服用。

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 周或更晚时服用 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.

包括SYMBRAVO在内的非甾体抗炎药（NSAIDs）不应在怀孕约30周后服用。

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

告诉你的医疗保健提供者你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您的所有健康状况，包括您是否：

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

have any risk factors for heart or blood vessel problems

有心脏或血管问题的任何风险因素

have kidney or liver problems

有肾脏或肝脏问题

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片剂。

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.

不要将SYMBRAVO给予其他人。

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，请立即拨打毒物控制中心电话1-800-222-1222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，请阅读随处方提供的信息。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

SYM CON BS 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 AXS-05

关于AXS-05

AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor under development for the treatment of Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components.

AXS-05（右美沙芬-安非他酮）是一种新型的、口服的、在研的N-甲基-D-天冬氨酸（NMDA）受体拮抗剂、σ-1激动剂和氨基酮CYP2D6抑制剂，正在开发用于治疗阿尔茨海默病（AD）激越和戒烟。AXS-05利用右美沙芬和安非他酮的专有配方和剂量，并结合Axsome的代谢抑制技术，以调节成分的释放。

The dextromethorphan component of AXS-05 is an uncompetitive NMDA receptor antagonist, also known as a glutamate receptor modulator, and a sigma-1 receptor agonist. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan and is a norepinephrine and dopamine reuptake inhibitor.

AXS-05的右美沙芬成分是一种非竞争性的NMDA受体拮抗剂，也被称为谷氨酸受体调节剂，以及σ-1受体激动剂。AXS-05中的安非他酮成分有助于提高右美沙芬的生物利用度，同时是一种去甲肾上腺素和多巴胺再摄取抑制剂。

AXS-05 is covered by a robust patent estate extending out to at least 2043. AXS-05 was granted .

AXS-05 拥有强大的专利资产保护，有效期至少延长至 2043 年。AXS-05 已获批准。

U.S.

美国

FDA Breakthrough Therapy designation for the treatment of Alzheimer’s disease agitation in

FDA授予治疗阿尔茨海默病躁动的突破性疗法认定

June 2020

2020年6月

.

。

About AXS-12

关于AXS-12

AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy. AXS-12 is thought to modulate noradrenergic activity to promote maintain tone during wakefulness, and noradrenergic and cortical dopamine signaling to promote wakefulness and enhance cognition.

AXS-12（瑞波西汀）是一种高选择性和强效的去甲肾上腺素再摄取抑制剂，同时作为皮质多巴胺调节剂，正在开发用于治疗嗜睡症。AXS-12被认为可通过调节去甲肾上腺素活性来促进和维持清醒状态，并通过去甲肾上腺素和皮质多巴胺信号传导来促进清醒和增强认知能力。

AXS-12 has been granted .

AXS-12 已被授予。

U.S. Food and Drug Administration

美国食品药品监督管理局

(FDA) Orphan Drug Designation for the treatment of narcolepsy. AXS-12 is covered by issued patents providing protection to at least 2039. AXS-12 is an investigational drug product not approved by the FDA.

AXS-12 已获得治疗嗜睡症的FDA孤儿药资格认定。AXS-12 受已颁发的专利保护，有效期至少至2039年。AXS-12 是一种研究性药物，尚未获得FDA批准。

About

关于

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.

Axsome Therapeutics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来实现科学突破，并专注于新颖作用机制，开发差异化产品，从而推动患者治疗结果的显著进步。

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 the .

我们行业领先的神经科学产品组合包括FDA批准的治疗重度抑郁症、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药物，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。

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

。共同努力，我们致力于解决大脑的一些最大问题，以便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为“前瞻性声明”。公司在某些情况下可能会使用“预测”、“相信”、“潜在”、“持续”、“估计”、“预期”、“计划”、“意图”、“可能”、“能够”、“也许”、“将”、“应该”等词语来表达未来事件或结果的不确定性，以识别这些前瞻性声明。

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属于此类前瞻性陈述的例子。前瞻性声明包含风险和不确定性，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计进行的临床试验的成功、时间安排和成本，包括关于试验启动时间、入组速度和完成情况的声明（包括公司全额资助其已披露临床试验的能力，此假设基于公司目前预计的收入或支出没有重大变化），无效性分析及中期结果的接收，这些结果不一定反映公司正在进行的临床试验的最终结果和/或数据读出结果，以及支持公司现有任何候选产品提交新药申请（“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；公司获取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 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产品候选物的批准或其他相关行动，包括任何新药申请（NDA）提交的时间；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（如果可能的话）；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；市场对公司产品及产品候选物的接受度（如获批准）；公司预期的资本需求，包括商业化Sunosi、Auvelity和Symbravo以及公司其他产品候选物（如获批准）商业发布所需的资本金额，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维持有利的总销售额至净销售额的能力；因国内政治气候、地缘政治冲突或全球大流行病引发的意外情况或其他对正常业务运营的干扰，以及其他因素，包括一般经济状况和公司无法控制的监管发展。

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 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这些陈述所表达或暗示的有重大差异。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这些前瞻性陈述以反映后续事件或情况的义务。

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

多普兰@axsome.com

Source: Axsome Therapeutics, Inc.

来源：Axsome Therapeutics, Inc.