Tonix anticipates filing the IND application in the fourth quarter of 2025

Tonix 预计将在 2025 年第四季度提交 IND 申请。

TNX-102 SL is a potential first-in-class treatment for targeting the disturbed sleep associated with depression

TNX-102 SL 是一种潜在的首创治疗药物，用于针对与抑郁症相关的睡眠障碍。

TNX-102 SL is FDA-approved for the treatment of fibromyalgia

TNX-102 SL 已获 FDA 批准用于治疗纤维肌痛。

CHATHAM, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the successful completion of a Type B Pre-Investigational New Drug (Pre-IND) meeting with the U.S.

新泽西州查塔姆，2025年9月18日（环球新闻社）——Tonix制药控股公司（纳斯达克：TNXP），一家拥有上市产品和开发候选药物管线的全集成生物技术公司，今天宣布成功完成与美国相关部门的B类临床前新药（Pre-IND）会议。

Food and Drug Administration (FDA) regarding the development of TNX-102 SL (sublingual cyclobenzaprine HCl) for the treatment of major depressive disorder (MDD). The Company received positive feedback from the FDA and plans to pursue a supplemental new drug application (sNDA) to expand the therapeutic indication of TNX-102 SL to include MDD, based on exploratory findings suggesting that improving sleep quality may positively impact depressive symptoms..

美国食品药品监督管理局（FDA）关于开发TNX-102 SL（舌下含服盐酸环苯扎林）用于治疗重度抑郁症（MDD）。公司收到了FDA的积极反馈，并计划提交补充新药申请（sNDA），以扩展TNX-102 SL的治疗适应症，将MDD包括在内，这是基于探索性研究结果表明改善睡眠质量可能对抑郁症状产生积极影响。

“We are pleased with the outcome of our Pre-IND meeting with the FDA and appreciate their thoughtful guidance,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “This marks a significant step forward in our efforts to develop TNX-102 SL as a novel treatment for MDD, a condition that affects millions and remains underserved by current therapies that are often difficult to tolerate.”.

“我们对与FDA召开的Pre-IND会议结果感到满意，并感谢他们的周到指导，”Tonix Pharmaceuticals首席执行官Seth Lederman博士说道。“这是我们为开发TNX-102 SL作为MDD新型治疗方案所迈出的重要一步。MDD影响数百万人，而当前疗法往往难以耐受，患者需求尚未得到满足。”

“We believe bedtime TNX-102 SL has the potential to be a first-in-class treatment that is designed to target the reduced quality and quantity of slow wave sleep associated with depression,” said Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “TNX-102 SL is a tertiary amine tricyclic that is designed for transmucosal absorption to bypass first pass hepatic metabolism.

“我们相信睡前服用TNX-102 SL有潜力成为一种首创的治疗方法，旨在针对与抑郁症相关的慢波睡眠质量和数量减少的问题，”Tonix Pharmaceuticals首席医学官Gregory Sullivan博士表示。“TNX-102 SL是一种设计用于经黏膜吸收从而绕过首过肝脏代谢的三环类叔胺药物。

In contrast, FDA-approved tertiary amine tricyclic antidepressants are swallowed pill formulations, that are largely metabolized by first-pass to longer-lived secondary amine tricyclics. Also, the FDA-approved tertiary amine tricyclic antidepressants are only active in treating MDD at more than ten times the dose employed with TNX-102 SL and can adversely impact weight, blood pressure, cognition, and sexual function.”.

相比之下，FDA批准的三环类抗抑郁药为口服药片制剂，主要通过首过代谢转化为寿命更长的仲胺三环类化合物。此外，FDA批准的三环类抗抑郁药只有在剂量超过TNX-102 SL十倍以上时才对治疗重度抑郁症有效，并且可能对体重、血压、认知能力和性功能产生不良影响。"

The FDA provided constructive feedback during the Pre-IND meeting for TNX-102 SL in MDD and found the proposed long-term safety data collection plan generally reasonable, potentially streamlining the development path.

FDA 在 TNX-102 SL 用于 MDD 的 Pre-IND 会议上提供了建设性的反馈，认为所提出的长期安全性数据收集计划总体合理，可能有助于简化开发路径。

An IND filing is planned for Q4 2025, positioning the program to enter Phase 2 clinical trials shortly thereafter. TNX-102 SL is FDA approved for the treatment of fibromyalgia, under the brand name Tonmya™. In the Phase 3 RESILIENT study of fibromyalgia patients, the TNX-102 SL – treated group had activity on improving depression over placebo by the Beck Depression Inventory (BDI), with an uncorrected p-value < 0.05.

计划于2025年第四季度提交IND申请，以便该项目随后进入第二阶段临床试验。TNX-102 SL已获得FDA批准用于治疗纤维肌痛，品牌名为Tonmya™。在纤维肌痛患者第三阶段RESILIENT研究中，使用TNX-102 SL治疗的组别通过贝克抑郁量表（BDI）显示出比安慰剂更显著的抗抑郁效果，未经校正的p值<0.05。

The biological relationship between depressed symptoms in fibromyalgia and those in MDD is not understood..

纤维肌痛中的抑郁症状与重度抑郁症中的抑郁症状之间的生物学关系尚不明确。

About TNX-102 SL

关于TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride that enables rapid transmucosal absorption and reduces production of the long half-life active metabolite, norcyclobenzaprine, by bypassing first-pass hepatic metabolism. As a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors.

TNX-102 SL 是一种获得专利的环苯扎林盐酸盐舌下片剂，能够实现快速的跨黏膜吸收，并通过绕过首过肝代谢减少长半衰期活性代谢物去甲环苯扎林的生成。作为一种叔胺三环类（TAT）多功能药物，它在5-HT2A血清素能、α1-肾上腺素能、H1-组胺能和M1-毒蕈碱受体上具有强效的结合与拮抗活性。

It is currently approved in the U.S. as a once-daily bedtime treatment for fibromyalgia in adults. TNX-102 SL is also in development as a daily bedtime treatment for acute stress reaction/acute stress disorder. Tonix also holds active IND’s for the following indications for TNX-102 SL: Long COVID (post-acute sequelae of COVID-19), PTSD, alcohol use disorder, and agitation in Alzheimer’s disease.

目前，该药物在美国被批准作为成人纤维肌痛的每日一次睡前治疗药物。TNX-102 SL还正在开发用于急性应激反应/急性应激障碍的每日睡前治疗。Tonix公司还持有TNX-102 SL在以下适应症中的有效研究性新药申请（IND）：长期新冠（新冠后急性后遗症）、创伤后应激障碍（PTSD）、酒精使用障碍以及阿尔茨海默病患者的激越症状。

The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary composition.

美国专利商标局（USPTO）于2017年5月颁发了美国专利第9636408号，2018年5月颁发了专利第9956188号，2018年11月颁发了专利第10117936号，2019年7月颁发了专利第10357465号，并于2020年8月颁发了专利第10736859号。专利中声称的Protectic™保护性共晶和Angstro-Technology™配方是Tonix专有组成的重要元素。

These patents are expected to provide Tonmya with U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044..

这些专利预计将为Tonmya提供到2034年的美国市场独占权。与使用方法相关的待批专利申请可能将独占权延长至2044年。

Tonix Pharmaceuticals Holding Corp.

托尼克斯制药控股公司

Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix recently received FDA approval for Tonmya™, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults.

Tonix制药是一家完全整合的生物技术公司，拥有已上市的产品和一条在研候选药物管线。Tonix最近获得了FDA对其产品Tonmya™的批准，这是一种首创的、非阿片类镇痛药，用于治疗纤维肌痛，一种影响数百万成年人的慢性疼痛疾病。

This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology and infectious diseases.

这标志着15年来首个治疗纤维肌痛的新处方药获得批准。Tonix还销售两种用于成人急性偏头痛的治疗药物。Tonix的研发组合专注于中枢神经系统（CNS）疾病、免疫学、免疫肿瘤学和传染病。

TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases.

TNX-102 SL 正在北卡罗来纳大学的医师发起的研究性新药（IND）下进行开发，用于治疗急性应激反应和急性应激障碍，该研究属于由美国国防部（DoD）资助的OASIS研究。Tonix的免疫学开发组合包括用于应对器官移植排斥、自身免疫和癌症的生物制品，其中包括TNX-1500，这是一种Fc修饰的人源化单克隆抗体，靶向CD40配体（CD40L或CD154），正在开发用于预防同种异体移植排斥和治疗自身免疫疾病。

Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments.

Tonix的传染病产品组合包括TNX-801，一种正在研发中的猴痘和天花疫苗，以及TNX-4200，Tonix与美国国防部国防威胁减少局（DTRA）签订了为期五年、价值高达3400万美元的合同。TNX-4200是一种小分子广谱抗病毒药物，靶向CD45，用于预防或治疗感染，以提高军事人员在生物威胁环境中的医疗准备能力。

Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md..

Tonix 在马里兰州弗雷德里克拥有一座最先进的传染病研究设施并负责运营。

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

* Tonix的产品开发候选药物为研究性新药或生物制品；其有效性和安全性尚未确立，也未获批准用于任何适应症。

This press release and further information about Tonix can be found at

这篇新闻稿以及有关Tonix的更多信息可以在以下网址找到：

www.tonixpharma.com

www.tonixpharma.com

.

。

Forward Looking Statements

前瞻性声明

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others.

本新闻稿中的某些陈述属于1995年《私人证券诉讼改革法案》定义的前瞻性陈述。这些陈述可能通过使用诸如“预期”、“相信”、“预测”、“估计”、“预计”和“意图”等前瞻性词语来识别。

These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition.

这些前瞻性陈述基于Tonix的当前预期，实际结果可能会有重大差异。有许多因素可能导致实际事件与这些前瞻性陈述所表明的情况有重大差异。这些因素包括但不限于：未能成功推出和商业化Tonmya及我们任何获批产品相关的风险；未能获得FDA核准或不符合FDA法规相关的风险；与我们候选产品临床开发的时间和进展相关的风险；我们对额外融资的需求；专利保护和诉讼的不确定性；政府或第三方支付者报销的不确定性；研发工作有限且依赖第三方；以及激烈的竞争。

As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof.

与任何正在开发的药物一样，新产品的开发、监管审批和商业化过程中存在重大风险。Tonix 不承担更新或修改任何前瞻性声明的义务。投资者应阅读公司于2025年3月18日向美国证券交易委员会（“SEC”）提交的截至2024年12月31日的年度报告表格10-K中的风险因素，以及在该日期或之后向SEC提交的定期报告。

Investor Contact

投资者联系方式

Jessica Morris

杰西卡·莫里斯

Tonix Pharmaceuticals

托尼克斯制药公司

investor.relations@tonixpharma.com

投资者关系@tonixpharma.com

(862) 799-8599

(862) 799-8599

Brian Korb

布莱恩·科尔布

astr partners

天体伙伴

brian.korb@astrpartners.com

brian.korb@astrpartners.com

(917) 653-5122

(917) 653-5122

Media Contact

媒体联系人

Ray Jordan

雷·乔丹

Putnam Insights

普特南洞察

ray@putnaminsights.com

ray@putnaminsights.com

(949) 245-5432

(949) 245-5432

INDICATION

适应症

TONMYA is indicated for the treatment of fibromyalgia in adults.

TONMYA 适用于治疗成人的纤维肌痛。

CONTRAINDICATIONS

禁忌症

TONMYA is contraindicated:

TONMYA 禁用于：

In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.

对环苯扎林或TONMYA中任何非活性成分过敏的患者。过敏反应可能表现为过敏性反应、荨麻疹、面部和/或舌部肿胀或瘙痒。如果怀疑发生过敏反应，请停止使用TONMYA。

With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs..

与单胺氧化酶（MAO）抑制剂同时使用或在停用MAO抑制剂后的14天内。接受环苯扎林（或结构类似的三环类抗抑郁药）与MAO抑制剂药物同时使用的患者中已出现过高热危象、癫痫发作和死亡。

During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.

在心肌梗塞的急性恢复期，以及在心律失常、心脏传导阻滞或传导障碍、充血性心力衰竭的患者中。

In patients with hyperthyroidism.

甲状腺功能亢进的患者。

WARNINGS AND PRECAUTIONS

警告和注意事项

Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose.

胚胎胎儿毒性：根据动物数据，TONMYA在受孕前两周及妊娠首三个月使用时可能引起神经管缺陷。建议有生育潜力的女性注意潜在风险，并在治疗期间及最后一剂后的两周内使用有效避孕措施。

Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy..

在开始使用TONMYA治疗之前，进行妊娠测试，以排除在妊娠前三个月内使用TONMYA的情况。

Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition.

血清素综合征：TONMYA与选择性5-羟色胺再摄取抑制剂（SSRIs）、5-羟色胺去甲肾上腺素再摄取抑制剂（SNRIs）、三环类抗抑郁药、曲马多、安非他酮、哌替啶、维拉帕米或单胺氧化酶抑制剂（MAO inhibitors）同时使用会增加血清素综合征的风险，这是一种可能危及生命的状况。

Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive.

5-羟色胺综合征症状可能包括精神状态改变、自主神经不稳定、神经肌肉异常和/或胃肠道症状。如果出现5-羟色胺综合征症状，应立即停止使用TONMYA和任何同时使用的血清素能药物，并给予支持性治疗。

symptomatic treatment should be initiated.

应开始对症治疗。

If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.

如果临床需要TONMYA与其他血清素能药物同时治疗，建议密切观察，特别是在治疗开始或剂量增加期间。

Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA.

三环类抗抑郁药类似的不良反应：环苯扎林在结构上与三环类抗抑郁药相关。据报道，三环类抗抑郁药可导致心律失常、窦性心动过速、传导时间延长，进而引发心肌梗死和中风。如果出现临床显著的中枢神经系统（CNS）症状，应考虑停用TONMYA。

Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures..

当TCAs给予有癫痫发作史的患者时应谨慎，因为TCAs可能会降低癫痫发作阈值。在使用TCA期间，应监测有癫痫发作史的患者，以识别癫痫复发或癫痫发作频率增加的情况。

Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.

阿托品样作用：对有尿潴留、闭角型青光眼、眼压升高病史的患者以及正在服用抗胆碱能药物的患者慎用。

CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities..

中枢神经系统抑制和操作机动车或危险机械的风险：TONMYA单药治疗可能导致中枢神经系统抑制。TONMYA与酒精、巴比妥类药物或其他中枢神经系统抑制剂同时使用可能会增加中枢神经系统抑制的风险。应告知患者，在未合理确定TONMYA治疗不会对其从事此类活动的能力产生不利影响之前，不要操作机动车或危险机械。

Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia).

口腔黏膜不良反应：在TONMYA的临床研究中，与安慰剂相比，接受TONMYA治疗的患者出现口腔黏膜不良反应的频率更高。建议患者在使用TONMYA前用水湿润口腔，以降低口腔感觉变化（感觉减退）的风险。

Consider discontinuation of TONMYA if severe reactions occur..

如果发生严重反应，请考虑停止使用TONMYA。

ADVERSE REACTIONS

不良反应

The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

最常见的不良反应（发生率≥2%，且在TONMYA治疗的患者中比安慰剂治疗的患者发生率更高）包括口腔感觉减退、口腔不适、产品味道异常、嗜睡、口腔感觉异常、口腔疼痛、疲劳、口干和口腔溃疡。

DRUG INTERACTIONS

药物相互作用

MAO inhibitors: Life-threatening interactions may occur.

MAO抑制剂：可能会发生危及生命的相互作用。

Other serotonergic drugs: Serotonin syndrome has been reported.

其他血清素能药物：已有血清素综合征的报告。

CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.

中枢神经系统抑制剂：酒精、巴比妥类药物和其他中枢神经系统抑制剂的中枢神经系统抑制作用可能会增强。

Tramadol: Seizure risk may be enhanced.

曲马多：癫痫发作风险可能会增加。

Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

胍乙啶或其他作用相似的药物：这些药物的降压作用可能会被阻断。

USE IN SPECIFIC POPULATIONS

特定人群中的使用

Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

妊娠：根据动物数据，TONMYA 在用于孕妇时可能会对胎儿造成伤害。关于妊娠期间口服环苯扎林的可用观察数据有限，质量不足以说明 TONMYA 与重大出生缺陷、流产或不良母体或胎儿结局之间的风险。

Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED)..

建议孕妇关于母体接触TONMYA对胎儿的潜在风险，并避免在受孕前两周及妊娠头三个月使用TONMYA。向Tonix医药公司报告妊娠情况，请拨打不良事件报告热线1-888-869-7633（1-888-TNXPMED）。

Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition..

哺乳：少量已发表的病例报告称环苯扎林可少量转移到人乳中，但这些数据无法得到证实。目前尚无环苯扎林对哺乳婴儿的影响或对乳汁生成影响的数据。在考虑母亲使用TONMYA的临床需求时，应同时权衡母乳喂养对婴儿发育和健康的益处，以及TONMYA或潜在母体状况可能对哺乳婴儿造成的任何不良影响。

Pediatric use: The safety and effectiveness of TONMYA have not been established.

儿科使用：TONMYA 的安全性和有效性尚未确定。

Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients..

老年患者：在成年纤维肌痛患者临床试验中，接受TONMYA治疗的患者中没有65岁及以上的患者。TONMYA的临床试验未包括足够数量的65岁及以上的患者，因此无法确定他们是否与年轻成年患者反应不同。

Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C).

肝功能损害：对于轻度肝功能损害（HI）（Child Pugh A级）患者，TONMYA的推荐剂量为每日一次2.8 mg，睡前服用，低于肝功能正常患者的推荐剂量。不建议中度HI（Child Pugh B级）或重度HI（Child Pugh C级）患者使用TONMYA。

Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions..

环苯扎林在轻度肝功能不全和中度肝功能不全患者中的暴露量（AUC）较肝功能正常者增加，这可能会增加与TONMYA相关的不良反应风险。

Please see additional safety information in the full Prescribing Information.

请参阅完整处方信息中的更多安全信息。

To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

要报告可疑的不良反应，请联系Tonix Medicines, Inc.，电话：1-888-869-7633，或FDA，电话：1-800-FDA-1088，或访问www.fda.gov/medwatch。

Released September 18, 2025

发布于2025年9月18日