NEW YORK, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering innovative therapies for the management of central nervous system (CNS) disorders, today announced that AXS-12 (reboxetine), a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, achieved the primary endpoint in the ENCORE Phase 3 trial, demonstrating a statistically significant improvement in the frequency of cataplexy attacks compared to placebo.

2024年11月26日，纽约（环球通讯社）--Axsome Therapeutics，Inc.（纳斯达克：AXSM），一家开发和提供中枢神经系统（CNS）疾病管理创新疗法的生物制药公司，今天宣布，Axsome-12（瑞波西汀）是一种高选择性和有效的去甲肾上腺素再摄取抑制剂和皮质多巴胺调节剂，在ENCORE 3期试验中达到了主要终点，表明与安慰剂相比，猝倒发作频率有统计学上的显着改善。

AXS-12 was also well tolerated with long-term dosing with a safety profile consistent with that observed in previously completed trials. ENCORE was a multi-center, two-period Phase 3 trial evaluating the long-term efficacy and safety of AXS-12 in patients with narcolepsy with cataplexy, consisting of a 6-month open-label AXS-12 treatment period, followed by a 3-week double-blind, placebo-controlled, randomized withdrawal period.

AXS-12对长期给药的耐受性也很好，其安全性与先前完成的试验中观察到的一致。ENCORE是一项多中心，两期3期临床试验，评估AXS-12在发作性睡病伴猝倒患者中的长期疗效和安全性，包括6个月的开放标签AXS-12治疗期，然后是3周的双盲，安慰剂对照，随机戒断期。

The trial enrolled 68 patients in the 6-month AXS-12 treatment period. Patients (n=42) were then randomized in a 1:1 ratio to continue treatment with AXS-12 or to discontinue AXS-12 and switch to placebo for 3 weeks..

该试验在6个月的AXS-12治疗期间招募了68名患者。然后将患者（n=42）以1:1的比例随机分组，继续使用AXS-12治疗或停用AXS-12并改用安慰剂治疗3周。。

AXS-12 met the primary endpoint of the change from randomization in the frequency of cataplexy attacks as compared to placebo at week 3 of the double-blind period. Patients randomized to switch to placebo experienced a statistically significant worsening in the average weekly number of cataplexy attacks compared with patients randomized to continue AXS-12 treatment, with an increase of 10.29 attacks per week with placebo versus 1.32 with AXS-12, at 3 weeks (p=0.017)..

在双盲期的第3周，与安慰剂相比，AXS-12达到了猝倒发作频率随机化变化的主要终点。与随机接受AXS-12治疗的患者相比，随机接受安慰剂治疗的患者每周平均瘫痪发作次数在统计学上显着恶化，安慰剂组每周发作次数增加10.29次，而AXS-12组每周发作次数增加1.32次（p=0.017）。。

“Clinical evidence continues to support AXS-12 as a novel treatment option for narcolepsy that has the potential to rapidly and durably ameliorate one of the most debilitating symptoms for patients, cataplexy, while also reducing the severity of excessive daytime sleepiness, and improving cognition and overall function,” commented Dr.

“临床证据继续支持AXS-12作为发作性睡病的一种新型治疗选择，它有可能快速持久地改善患者最虚弱的症状之一，即瘫痪，同时还可以减轻白天过度嗜睡的严重程度，改善认知和整体功能，”Dr。

Michael Thorpy, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine. “Narcolepsy is a complex and heterogeneous condition defined by distinct symptom clusters and there remains great need for options that can address this variety in disease presentation.

迈克尔·索普（MichaelThorpy），蒙特菲奥雷医学中心睡眠-觉醒障碍中心主任，阿尔伯特·爱因斯坦医学院神经病学教授。“发作性睡病是一种复杂而异质的疾病，由不同的症状群定义，仍然非常需要能够解决疾病表现中这种多样性的选择。

The results from the ENCORE study support AXS-12 as a potentially important new option for physicians and patients.”.

。

AXS-12 resulted in statistically significant benefit in cognition compared to placebo, as assessed by the Narcolepsy Symptom Assessment Questionnaire (NSAQ) and the Patient Global Impression of Change (PGI-C). A significantly greater proportion of patients randomized to switch to placebo experienced worsening on the NSAQ Ability to Concentrate item compared to those continuing on AXS-12 (52.6% versus 14.3%) at 3 weeks (p=0.011).

通过发作性睡病症状评估问卷（NSAQ）和患者整体变化印象（PGI-C）评估，与安慰剂相比，AXS-12在认知方面具有统计学显着的益处。与3周时继续服用AXS-12（52.6%比14.3%）的患者相比，随机改用安慰剂的患者中，NSAQ集中项目的能力明显恶化（p=0.011）。

A significantly greater proportion of patients randomized to switch to placebo also reported worsening in their ability to concentrate, as assessed by the PGI-C, compared to those continuing on AXS-12 (57.9% versus 22.2%) at 3 weeks (p=0.029)..

根据PGI-C的评估，与3周时继续服用AXS-12的患者（57.9%比22.2%）相比，随机改用安慰剂的患者比例也显着增加（p=0.029）。。

AXS-12 resulted in statistically significant benefit in narcolepsy overall compared to placebo, as assessed by the PGI-C. A significantly greater proportion of patients randomized to switch to placebo reported worsening of their narcolepsy, as assessed by the PGI-C, compared to those continuing on AXS-12 (52.6% versus 16.7%) at 3 weeks (p=0.024)..

根据 PGI-C 评估，与安慰剂相比，AXS-12 对嗜睡症的总体疗效具有显著的统计学意义。与继续服用 AXS-12 的患者（52.6% 对 16.7%）相比，在 PGI-C 评估中，随机改用安慰剂的患者在 3 周后报告嗜睡症恶化的比例明显更高（P=0.024）。

“The results of the ENCORE trial confirm the efficacy of AXS-12 in patients with narcolepsy with cataplexy, which has now been demonstrated in three positive controlled trials, and indicate that the potential benefits of AXS-12 are substantial and sustained with long-term treatment,” said Dr. Herriot Tabuteau, CEO of Axsome Therapeutics.

Axsome Therapeutics首席执行官赫里奥特·塔布托（Herriot Tabuteau）博士说：“ENCORE试验的结果证实了AXS-12对发作性睡病伴猝倒症患者的疗效，目前已在三项阳性对照试验中得到证实，并表明AXS-12的潜在益处是巨大的，并且可以通过长期治疗持续存在。”。

“We are pleased by the improvements not only in cataplexy, but also in excessive daytime sleepiness and cognition reported by a majority of patients in the trial with long-term AXS-12 treatment. Importantly, these improvements were accompanied by a favorable long-term safety and tolerability profile.

“我们感到高兴的是，在长期AXS-12治疗的试验中，大多数患者不仅在瘫痪方面有所改善，而且在白天过度嗜睡和认知方面也有所改善。重要的是，这些改善伴随着良好的长期安全性和耐受性。

We plan to move expeditiously towards an NDA filing for AXS-12 and intend to request a pre-NDA meeting with the FDA.”.

我们计划尽快为AXS-12提交保密协议，并打算要求与FDA举行保密协议前会议。”。

During the long-term open-label treatment portion of the trial, patients experienced substantial and sustained improvement of cataplexy with AXS-12 treatment. Patients experienced a 71% reduction from baseline in mean weekly cataplexy attacks at 1 month with AXS-12 treatment, which was sustained with long-term treatment resulting in a 77% reduction at 6 months.

在试验的长期开放标签治疗部分，患者通过AXS-12治疗经历了实质性和持续性的瘫痪改善。。

Cataplexy response, defined as ≥50% reduction from baseline in weekly cataplexy attacks, was achieved by 72% of patients at 1 month, and by 82% of patients at 6 months with AXS-12 treatment. Treatment with AXS-12 also substantially increased the percentage of cataplexy-free days (days with zero cataplexy attacks) per week from 14% at baseline to 61% at 1 month and 70% at 6 months..

72%的患者在1个月时达到猝倒反应，定义为每周猝倒发作比基线降低≥50%，82%的患者在6个月时接受AXS-12治疗。AXS-12治疗也大大提高了每周无瘫痪天数（无瘫痪发作天数）的百分比，从基线时的14%增加到1个月时的61%和6个月时的70%。。

Long-term open-label treatment with AXS-12 resulted in substantial improvements in excessive daytime sleepiness (EDS), assessed using the Epworth Sleepiness Scale (ESS) and the Clinician Global Impression of Change (CGI-C) scale. Mean ESS scores were reduced by 5.6 points at 1 month, with this improvement maintained with long-term treatment resulting in a mean reduction of 7.3 points at 6 months.

使用Epworth嗜睡量表（ESS）和临床医生全球变化印象（CGI-C）量表评估，使用AXS-12进行的长期开放标签治疗导致白天过度嗜睡（EDS）的显着改善。平均ESS评分在1个月时降低了5.6分，长期治疗后这种改善得以维持，导致6个月时平均降低了7.3分。

Clinicians reported improvement in EDS in a substantial proportion of patients on the CGI-C scale, with 84% of patients achieving EDS improvement at 1 month and 78% of patients at 6 months with AXS-12 treatment..

临床医生报告说，在CGI-C量表上，相当一部分患者的EDS有所改善，84%的患者在1个月时EDS有所改善，78%的患者在6个月时接受AXS-12治疗。。

A substantial proportion of patients reported improvement in cognition with AXS-12 which was sustained with long-term open-label treatment. Improvement in cognition, assessed by the NSAQ Ability to Concentrate item, was reported by 55% of patients at 1 month and 59% at 6 months with AXS-12 treatment.

相当大比例的患者报告说，AXS-12的认知能力有所改善，这是通过长期开放标签治疗得以维持的。。

Change in the ability to concentrate was also assessed using the PGI-C scale. The proportion of patients reporting improvement in the ability to concentrate on the PGI-C was 67% at 1 month and 70% at 6 months with AXS-12 treatment..

还使用PGI-C量表评估了集中能力的变化。AXS-12治疗后，报告专注于PGI-C能力改善的患者比例在1个月时为67%，在6个月时为70%。。

Long-term open-label treatment with AXS-12 was also associated with improvement in overall narcolepsy status and patient functioning, assessed using the CGI-C, the PGI-C, and the Work Productivity and Activity Impairment Questionnaire (WPAI). On the CGI-C, clinicians reported overall improvement in narcolepsy in 90% of patients at 1 month and also 90% of patients at 6 months with AXS-12 treatment.

使用CGI-C，PGI-C和工作效率和活动障碍问卷（WPAI）评估，AXS-12的长期开放标签治疗也与整体嗜睡症状态和患者功能的改善有关。。

Results were similar with the patient-reported PGI-C. Impairment due to narcolepsy while working was assessed after treatment with AXS-12 using the WPAI. The percentage of time impaired while working decreased substantially with AXS-12 treatment from 53% at baseline to 34% at 1 month and 24% at 6 months..

结果与患者报告的PGI-C相似。在使用WPAI用AXS-12治疗后，评估了工作时发作性睡病引起的损害。AXS-12治疗后，工作时间受损的百分比从基线的53%大幅下降到1个月的34%和6个月的24%。。

AXS-12 was well tolerated with long-term dosing. The safety profile with long-term dosing was consistent with prior trials of AXS-12 with no new safety signals identified. During the 6-month open-label treatment period, the most common adverse events (≥5%) were nausea (5.9%) and tachycardia (5.9%). Over the 6-month treatment period, 17.6% of patients discontinued due to adverse events, with no individual adverse event leading to discontinuation by more than 1 patient. Treatment-related adverse events during the double-blind period were reported in 4.5% of patients in the AXS-12 group and 15% of patients in the placebo group.

AXS-12长期给药耐受性良好。长期给药的安全性与之前的AXS-12试验一致，没有发现新的安全信号。在6个月的开放标签治疗期间，最常见的不良事件（≥5%）是恶心（5.9%）和心动过速（5.9%）。在6个月的治疗期间，17.6%的患者因不良事件而停药，没有个别不良事件导致超过1名患者停药。AXS-12组有4.5%的患者和安慰剂组有15%的患者报告了双盲期间与治疗相关的不良事件。

Rates of discontinuation due to adverse events in the double-blind period were 0% and 5% in the AXS-12 and placebo groups, respectively..

在双盲期间，AXS-12 组和安慰剂组因不良反应而停药的比例分别为 0% 和 5%。

AXS-12 has been granted Orphan Drug Designation for the treatment of narcolepsy. Orphan Drug Designation is granted to promising drugs intended for the safe and effective treatment of rare diseases, defined as those affecting fewer than 200,000 people in the U.S. This designation may entitle Axsome to a period of seven years of marketing exclusivity in the U.S.

AXS-12已被授予治疗发作性睡病的孤儿药称号。孤儿药指定是指用于安全有效治疗罕见疾病的有前途的药物，定义为在美国影响不到20万人的罕见疾病。该指定可能使Axsome在美国享有七年的独家销售期。

upon FDA approval and a waiver of the Company’s obligation to pay the FDA application user fees for the product as required by the Prescription Drug User Fee Act. AXS-12 is covered by issued patents providing protection to at least 2039..

根据《处方药使用费法案》的要求，在FDA批准并放弃公司支付FDA申请产品使用费的义务后。AXS-12拥有已颁发的专利，至少为2039年提供保护。。

Double-Blind Efficacy Highlights

双盲功效亮点

A total of 42 patients were randomized, 22 to continued treatment with AXS-12, and 20 switched to placebo. The primary endpoint was the change from randomization to week 3 in the weekly frequency of cataplexy attacks.

共有42名患者被随机分组，22名患者继续接受AXS-12治疗，20名患者改用安慰剂。主要终点是每周发作频率从随机化到第3周的变化。

The primary endpoint was achieved with patients randomized to switch to placebo experiencing a mean increase of 10.29 cataplexy attacks per week compared to a mean increase of 1.32 attacks per week for patients randomized to continue AXS-12 treatment, at 3 weeks (p=0.017).

主要终点是随机转换为安慰剂的患者每周平均增加10.29次猝倒发作，而随机接受AXS-12治疗的患者在3周时每周平均增加1.32次发作（p=0.017）。

A significantly greater proportion of patients randomized to switch to placebo experienced worsening on the NSAQ Ability to Concentrate item compared to those continuing on AXS-12 (52.6% versus 14.3%) at 3 weeks (p=0.011).

与3周时继续服用AXS-12（52.6%比14.3%）的患者相比，随机改用安慰剂的患者中，NSAQ集中项目的能力明显恶化（p=0.011）。

A significantly greater proportion of patients randomized to switch to placebo also reported worsening in their ability to concentrate, as assessed by the PGI-C, compared to those continuing on AXS-12 (57.9% versus 22.2%) at 3 weeks (p=0.029).

根据PGI-C的评估，与3周时继续服用AXS-12（57.9%比22.2%）的患者相比，随机改用安慰剂的患者比例也显着增加（p=0.029）。

A significantly greater proportion of patients randomized to switch to placebo reported worsening of their narcolepsy overall, as assessed by the PGI-C, compared to those continuing on AXS-12 (52.6% versus 16.7%) at 3 weeks (p=0.024).

根据PGI-C的评估，与3周时继续使用AXS-12的患者（52.6%比16.7%）相比，随机改用安慰剂的患者总体上报告发作性睡病恶化的比例明显更高（p=0.024）。

Long-Term Efficacy Highlights

长期疗效亮点

A total of 68 patients were treated with AXS-12 for up to 6 months in an open-label fashion. At baseline, the mean number of weekly cataplexy attacks was 31.3 and the mean ESS was 18. Efficacy results for this treatment period are summarized below:

共有68名患者以开放标签的方式接受了长达6个月的AXS-12治疗。在基线时，每周猝倒发作的平均次数为31.3次，平均ESS为18次。该治疗期间的疗效结果总结如下：

Cataplexy

瘫痪

Treatment with AXS-12 resulted in a mean reduction from baseline of 22.3 cataplexy attacks per week at 1 month, corresponding to a decrease of 71%. The improvement in cataplexy was maintained with long-term AXS-12 treatment, resulting in a mean reduction of 24.1 cataplexy attacks per week at 6 months, corresponding to a decrease of 77%..

AXS-12治疗导致1个月时每周平均减少22.3次猝倒发作，相当于减少71%。长期AXS-12治疗维持了瘫痪的改善，导致6个月时每周平均减少24.1次瘫痪发作，相当于减少了77%。。

Cataplexy response, defined as ≥50% reduction from baseline in the weekly frequency of cataplexy attacks, was achieved by 72% of patients at 1 month, and by 82% of patients at 6 months with AXS-12 treatment.

72%的患者在1个月时达到瘫痪反应，定义为每周发作频率比基线降低≥50%，82%的患者在6个月时接受AXS-12治疗。

AXS-12 increased the percentage of cataplexy free days (days with zero cataplexy attacks) per week from 14.3% at baseline to 61% at 1 month and 70% at 6 months.

AXS-12将每周无瘫痪天数（无瘫痪发作的天数）的百分比从基线时的14.3%增加到1个月时的61%和6个月时的70%。

Excessive Daytime Sleepiness (EDS)

白天过度嗜睡（EDS）

Treatment with AXS-12 resulted in mean reductions from baseline in the ESS score of 5.6 points at 1 month and 7.3 points at 6 months.

AXS-12治疗导致ESS评分从基线平均降低，1个月时为5.6分，6个月时为7.3分。

EDS, assessed by the Clinician Global Impression of Change (CGI-C), was improved in 84% of patients at 1 month, and in 78% of patients at 6 months with AXS-12 treatment.

由临床医生全球变化印象（CGI-C）评估的EDS在1个月时有84%的患者得到改善，在AXS-12治疗6个月时有78%的患者得到改善。

Cognition

认知

AXS-12 treatment was associated with an improvement in cognition, assessed by the NSAQ Ability to Concentrate item, with 55% of patients reporting improvement at 1 month, and 59% reporting improvement at 6 months.

通过NSAQ集中项目的能力评估，AXS-12治疗与认知改善相关，55%的患者在1个月时报告改善，59%的患者在6个月时报告改善。

AXS-12 treatment was also associated with an improvement in the ability to concentrate, assessed by the PGI-C, with 67% of patients reporting improvement at 1 month, and 70% reporting improvement at 6 months.

根据PGI-C的评估，AXS-12治疗还与注意力集中能力的提高有关，67%的患者在1个月时报告有所改善，70%的患者在6个月时报告有所改善。

Narcolepsy Overall, Work Productivity

嗜睡症总体而言，工作效率

Narcolepsy overall, assessed by the CGI-C, was improved in 90% of patients at 1 month and 90% at 6 months with AXS-12 treatment.

CGI-C评估的发作性睡病总体上在AXS-12治疗后1个月时有90%的患者改善，6个月时有90%的患者改善。

AXS-12 treatment was associated with an improvement in narcolepsy overall, assessed by the PGI-C, with 78% of patients reporting improvement at 1 month, and 80% reporting improvement at 6 months.

根据PGI-C的评估，AXS-12治疗与发作性睡病的总体改善有关，78%的患者在1个月时报告有改善，80%的患者在6个月时报告有改善。

AXS-12 treatment was associated with improved patient function by substantially decreasing the time impaired due to narcolepsy while working, assessed by the WPAI, from 53% at baseline to 34% at 1 month and 24% at 6 months.

通过WPAI评估，AXS-12治疗与改善患者功能相关，大大减少了工作时因嗜睡症而受损的时间，从基线时的53%降至1个月时的34%和6个月时的24%。

Long-Term Safety and Tolerability Highlights

长期安全性和耐受性亮点

Safety results are for all patients enrolled in the ENCORE trial (n=68). Safety results for the 6-month treatment and double-blind periods are summarized below.

安全性结果适用于所有参加ENCORE试验的患者（n=68）。。

AXS-12 was well tolerated with a safety profile that was consistent with what was previously observed in completed, short-term controlled trials, with no new safety signals detected.

AXS-12耐受性良好，安全性与之前在完成的短期对照试验中观察到的一致，未检测到新的安全信号。

The most commonly reported adverse events (≥5%) were nausea (5.9%) and tachycardia (5.9%).

最常报告的不良事件（≥5%）是恶心（5.9%）和心动过速（5.9%）。

Discontinuations due to adverse events occurred in 17.6% of patients, with no individual event leading to discontinuation by more than 1 patient.

17.6%的患者因不良事件而停药，没有个别事件导致超过1名患者停药。

During the double-blind period, the rates of treatment-related adverse events were 4.5% in the AXS-12 group and 15.0% in the placebo group. Discontinuations due to adverse events in the double-blind period occurred in no patients in the AXS-12 group and in 1 patient in the placebo group.

在双盲期间，AXS-12组的治疗相关不良事件发生率为4.5%，安慰剂组为15.0%。AXS-12组无患者和安慰剂组1例患者因双盲期不良事件而停药。

About the ENCORE Study

关于安可研究

ENCORE (Evaluating Continued Treatment with Reboxetine) was a multicenter Phase 3 trial consisting of a 24-week open-label period followed by a 3-week, double-blind, randomized withdrawal period to evaluate the efficacy and long-term safety of AXS-12 in patients with narcolepsy. A total of 68 patients, who rolled over from the SYMPHONY Phase 3 trial of AXS-12, were enrolled into the open-label period and treated with AXS-12 (5 mg) once-daily for the first week, followed by twice daily dosing for the next 23 weeks.

ENCORE（评估瑞波西汀的持续治疗）是一项多中心3期临床试验，包括24周的开放标签期，然后是3周的双盲随机停药期，以评估AXS-12在发作性睡病患者中的疗效和长期安全性。。

Patients who completed the open-label treatment period (n=42) were then randomized in a 1:1 ratio to continue on AXS-12 (n=22) or to switch to placebo (n=20). The mean number of cataplexy attacks at baseline was 31.3. The mean number of cataplexy attacks at randomization was 4.2 (AXS-12) and 6.9 (placebo).

然后将完成开放标签治疗期（n=42）的患者以1:1的比例随机分组，继续使用AXS-12（n=22）或改用安慰剂（n=20）。基线时猝倒发作的平均次数为31.3次。随机分组的平均猝倒发作次数为4.2（AXS-12）和6.9（安慰剂）。

The prespecified primary efficacy endpoint was the change in frequency of weekly cataplexy attacks from baseline at randomization to week 3 of the double-blind period. Other symptoms of narcolepsy as well as safety and tolerability were assessed throughout the study..

预先设定的主要疗效终点是每周猝倒发作频率从随机基线到双盲期第3周的变化。在整个研究过程中评估了发作性睡病的其他症状以及安全性和耐受性。。

About Narcolepsy

关于嗜睡症

Narcolepsy is a serious and debilitating orphan neurological condition that causes dysregulation of the sleep-wake cycle and is characterized clinically by excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep.1-3 Cataplexy is seen in an estimated 70% of narcolepsy patients and is a sudden reduction or loss of muscle tone while a patient is awake, typically triggered by strong emotions such as laughter, fear, anger, stress, or excitement.4-5 Narcolepsy is a life-long condition that interferes with cognitive, psychological, and social functioning, increases the risk of work- and driving-related accidents, and is associated with a 1.5-fold higher mortality rate.6-8.

发作性睡病是一种严重且使人衰弱的孤儿神经系统疾病，会导致睡眠-觉醒周期失调，临床特征是白天过度嗜睡，猝倒，幻觉，睡眠麻痹和夜间睡眠中断。1-3据估计，70%的发作性睡病患者出现猝倒，是患者清醒时肌肉张力突然降低或丧失，通常由强烈的情绪（例如笑声，恐惧，愤怒，压力或兴奋）触发。4-5发作性睡病是一种终身疾病，会干扰认知，心理和社会功能，增加与工作和驾驶有关的事故的风险，并与1死亡率高出0.5倍.6-8。

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）是一种高度选择性和有效的去甲肾上腺素再摄取抑制剂和皮质多巴胺调节剂，正在开发用于治疗发作性睡病。AXS-12被认为可以调节去甲肾上腺素能活动以促进清醒期间的维持音调，去甲肾上腺素能和皮质多巴胺信号传导可促进清醒并增强认知。

AXS-12 has been granted U.S. Food and Drug Administration (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已被美国食品和药物管理局（FDA）授予治疗发作性睡病的孤儿药名称。AXS-12拥有已颁发的专利，至少为2039年提供保护。AXS-12是一种未经FDA批准的研究药物产品。。

About Axsome Therapeutics

关于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是一家生物制药公司，引领中枢神经系统（CNS）疾病治疗的新时代。。

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 United States.

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，以及针对影响美国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。

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 www.axsome.com..

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。有关更多信息，请访问公司网站www.axsome.com。。