Axsome Therapeutics提供了关于 AXS-14用于治疗纤维肌痛的新药申请 (NDA)的更新-动脉网

Axsome Therapeutics Provides Update on the New Drug Application (NDA) for AXS-14 for the Management of Fibromyalgia

Axsome Therapeutics 等信源发布 2025-06-09 19:18

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NEW YORK

纽约

，

June 09, 2025

2025年6月9日

(GLOBE NEWSWIRE) --

（环球新闻网）--

Axsome Therapeutics, Inc.

(NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it has received a Refusal to File (RTF) letter from the

(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，今日宣布已收到一份拒绝受理（RTF）函。

U.S. Food and Drug Administration

美国食品药品监督管理局

(FDA) for its New Drug Application (NDA) for AXS-14 (esreboxetine) for the management of fibromyalgia.

美国食品和药物管理局（FDA）受理了AXS-14（艾司瑞波西汀）用于治疗纤维肌痛的新药申请（NDA）。

The FDA states that upon preliminary review, it found that the NDA was not sufficiently complete to permit a substantive review. Specifically, the FDA does not consider the second of the two placebo-controlled trials in the submission to be adequate and well-controlled because its primary endpoint was at 8 weeks and it used a flexible-dose paradigm.

美国食品药品监督管理局（FDA）表示，经过初步审查，发现新药申请（NDA）不够完整，无法进行实质性审查。具体来说，FDA认为提交的两项安慰剂对照试验中的第二项并不充分且未得到良好控制，因为其主要终点是在第8周，且采用了灵活剂量的设计。

The FDA indicated that the first of the two placebo-controlled trials in the submission, which utilized a 12-week endpoint and a fixed-dose paradigm, is adequate and well-controlled. The FDA did not raise any questions relating to the positive results of the studies, both of which met their primary endpoints..

FDA 表示，提交的两项安慰剂对照试验中的第一项采用了 12 周终点和固定剂量模式，是充分且良好控制的。FDA 没有对研究的积极结果提出任何问题，这两项研究均达到了其主要终点。

To address the FDA’s feedback, Axsome will conduct an additional controlled trial, which will use a fixed-dose paradigm and a 12-week primary endpoint as requested by the FDA. Axsome anticipates initiating this trial in the fourth quarter of 2025.

为了解决FDA的反馈，Axsome将开展一项额外的对照试验，该试验将采用FDA要求的固定剂量模式和12周的主要终点。Axsome预计将在2025年第四季度启动这项试验。

“The clear feedback provided by the FDA’s

“FDA提供的明确反馈”

Division of Anesthesiology

麻醉学部

, Addiction Medicine, and Pain Medicine allows us to move expeditiously with the continued development of this important investigational medicine for the approximately 17 million patients in the

，成瘾医学和疼痛医学使我们能够迅速推进这种重要的研究性药物的持续开发，以惠及大约1700万患者。

U.S.

美国

living with fibromyalgia. We are well positioned to initiate a new controlled trial that will incorporate the FDA’s feedback by the end of 2025,” said

生活在纤维肌痛中。我们有能力在2025年底前启动一个新的对照试验，该试验将结合FDA的反馈，”

Herriot Tabuteau

埃里奥·塔布特

, MD, Chief Executive Officer of Axsome. “As highlighted in the FDA’s Patient-Focused Drug Development Initiative report

，医学博士，Axsome首席执行官。“正如FDA的以患者为中心的药物研发计划报告中强调的那样

The Voice of the Patient: Fibromyalgia

患者之声：纤维肌痛症

, patients with fibromyalgia experience debilitating widespread pain, fatigue, and functional impairment, and report living with constant stigmatization, anxiety, depression, and fear of ongoing or worsening symptoms. We are excited and motivated by the potential for AXS-14 to address this high unmet medical need for patients, as evidenced by the consistent efficacy demonstrated to date across a broad range of fibromyalgia symptoms, including significant improvements in pain, function, and fatigue, in the completed trials.”.

纤维肌痛患者经历着令人虚弱的广泛疼痛、疲劳和功能障碍，并报告称生活在持续的污名化、焦虑、抑郁以及对症状持续或恶化的恐惧中。我们对AXS-14解决这一高度未满足的医疗需求的潜力感到兴奋并受到激励，迄今为止在已完成的试验中，AXS-14在广泛的纤维肌痛症状中表现出了一致的疗效，包括在疼痛、功能和疲劳方面的显著改善。

About AXS-14

关于AXS-14

AXS-14 (esreboxetine) is a highly selective and potent norepinephrine reuptake inhibitor for the management of fibromyalgia and other conditions. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine. AXS-14 is an investigational drug product not approved by the FDA..

AXS-14（esreboxetine）是一种高效且选择性强的去甲肾上腺素再摄取抑制剂，用于治疗纤维肌痛及其他疾病。Esreboxetine是reboxetine的SS对映体，比外消旋的reboxetine更有效且更具选择性。AXS-14是一种尚未获得FDA批准的研究性药物产品。

About Fibromyalgia

关于纤维肌痛

Fibromyalgia is a chronic debilitating disorder characterized by widespread pain, fatigue, disturbed sleep, depression, and cognitive impairment.

纤维肌痛是一种慢性致残性疾病，其特征为全身疼痛、疲劳、睡眠障碍、抑郁和认知障碍。

Other symptoms of this disorder can include tingling in the hands and feet and headaches.

这种疾病的其他症状可能包括手足刺痛和头痛。

Fibromyalgia has considerable detrimental effects on physical, emotional, social, and day-to-day functioning.

纤维肌痛对身体、情绪、社交和日常功能有相当大的不利影响。

Fibromyalgia is considered to be mediated mainly in the central nervous system. Approximately 17 million Americans, 90% of whom are women, are estimated to suffer from fibromyalgia.

纤维肌痛被认为主要由中枢神经系统介导。据估计，大约有1700万美国人患有纤维肌痛，其中90%是女性。

Treatment options for fibromyalgia are limited with only three pharmacologic treatments currently approved by the FDA.

纤维肌痛的治疗选择有限，目前只有三种药物治疗获得FDA批准。

About

关于

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空白，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治疗进步。

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 .

我们的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白天过度嗜睡以及偏头痛的疗法，并且还有多个后期开发项目，针对影响超过1.5亿人的各种严重的神经和精神疾病。

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，以便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

and follow us on

关注我们

领英

and

和

。

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“前瞻性陈述”。公司在某些情况下可能会使用“预测”、“相信”、“潜在”、“继续”、“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期临床试验的成功、时间安排和成本，针对公司当前候选产品的相关声明，包括关于试验启动时间、入组进度和完成情况（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收入或支出无重大变化）、无效性分析和中期结果的接收，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/或数据输出，同时包括支持公司当前候选产品新药申请（“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 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”) 或其他监管机构对公司产品候选物的批准或其他行动，包括任何新药申请（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度（如获批准）；公司预期的资本需求，包括用于SUNOSI、AUVELITY和SYMBRAVO商业化以及公司其他产品候选物商业化推出（如获批准）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保持有利的总销售额至净销售额的能力；由于国内政治气候、地缘政治冲突或全球疫情引发的不可预见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监管发展，这些均不在公司的控制范围内。

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

mjacobson@axsome.com

Media:

媒体：

Darren Opland