TONMYA demonstrated significant reduction in fibromyalgia pain compared with placebo in the Phase 3 RESILIENT study TONMYA在三期RESILIENT研究中显示出比安慰剂显著减少纤维肌痛疼痛的效果Unique sublingual formulation designed for bedtime dosing bypasses first-pass metabolism, optimizing parent-drug exposure during sleep and decreasing levels of the persistent active metabolite 专为睡前服用设计的独特舌下制剂，绕过首过代谢，优化睡眠期间母体药物的暴露量，并减少持续活性代谢物的水平。Treatment was well tolerated with minimal effects on weight or blood pressure 治疗耐受性良好，对体重或血压的影响极小。CHATHAM, N.J., Jan. 30, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ('Tonix' or the 'Company'), a fully integrated, commercial biotechnology company, presented data on TONMYA™, which was investigated as TNX-102 SL, at the 2026 Non-Opioid Pain Therapeutics Summit, on January 29, 2026, in Boston, Massachusetts. 新泽西州查塔姆，2026年1月30日（环球新闻社）——Tonix Pharmaceuticals Holding Corp.（纳斯达克股票代码：TNXP）（“Tonix”或“公司”），一家完全整合的商业生物技术公司，于2026年1月29日在马萨诸塞州波士顿举行的2026年非阿片类镇痛治疗峰会上展示了TONMYA™（作为TNX-102 SL研究）的数据。A copy of the Company's presentation, titled . 公司演讲的副本，标题为。'TNX-102 SL (Sublingual Cyclobenzaprine HCl): a Centrally Acting Non-Opioid Analgesic for the Treatment of Fibromyalgia,' 'TNX-102 SL（舌下含服环苯扎林盐酸盐）：一种用于治疗纤维肌痛的中枢作用非阿片类镇痛药，' is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com. 可在Tonix网站的“科学报告”标签下找到，网址为www.tonixpharma.com。'Fibromyalgia is a chronic pain disorder affecting more than 10 million adults in the U.S., with existing treatments often limited by tolerability and side effects,' said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. 'The data presented at the Non-Opioid Pain Therapeutics Summit by our Chief Medical Officer, Gregory Sullivan, M.D. “纤维肌痛是一种慢性疼痛障碍，影响着美国超过1000万成年人，现有治疗方案常常受到耐受性和副作用的限制，”Tonix制药公司首席执行官Seth Lederman博士说道。“我们的首席医疗官Gregory Sullivan博士在非阿片类镇痛治疗峰会上展示的数据。”highlight TONMYA'S role as a centrally-acting, differentiated non-opioid treatment. TONMYA'S unique sublingual formulation is designed for bedtime administration and to bypass first-pass metabolism, resulting in a pharmacokinetic profile that favors parent-drug exposure during sleep while limiting daytime exposure to the active metabolite. 突出TONMYA作为中枢作用的、与众不同的非阿片类治疗药物的角色。TONMYA独特的舌下含服制剂设计用于睡前服用，以绕过首过代谢，从而形成有利于在睡眠期间暴露于母体药物的药代动力学特征，同时限制白天对活性代谢物的暴露。Since fibromyalgia patients are commonly prescribed opioids off-label, there is a clear need for effective non-opioid alternatives.'. 由于纤维肌痛患者通常会被开具标签外使用的阿片类药物，因此对有效的非阿片类替代药物有明显的需求。The data presented at the Summit come from RESILIENT, a 14-week randomized, double-blind, placebo-controlled Phase 3 trial at 34 U.S. sites, with 456 intent-to-treat participants who met the 2016 American College of Rheumatology criteria for fibromyalgia. Participants received TONMYA or placebo administered sublingually at bedtime. 峰会上提供的数据来自 RESILIENT，这是一项为期 14 周的随机、双盲、安慰剂对照的第 3 阶段试验，在美国 34 个试验点进行，共有 456 名意向治疗参与者符合 2016 年美国风湿病学会的纤维肌痛标准。参与者在睡前舌下接受 TONMYA 或安慰剂。Treatment with TONMYA resulted in a statistically significant reduction in weekly average pain scores at Week 14 (p<0.0001) versus placebo, with an effect size of 0.38. The study also demonstrated significant improvements in key secondary endpoints, including sleep disturbance (p<0.001), fatigue (p<0.001), and the Symptoms (p<0.001) and Function (p=0.001) domains of the Fibromyalgia Impact Questionnaire-Revised (p<0.001 for both). TONMYA 治疗在第 14 周时，与安慰剂相比，每周平均疼痛评分显著降低（p<0.0001），效应量为 0.38。研究还显示关键次要终点也有显著改善，包括睡眠障碍（p<0.001）、疲劳（p<0.001）以及纤维肌痛影响问卷修订版 (FIQR) 的症状（p<0.001）和功能（p=0.001）领域（两者均为 p<0.001）。TONMYA was well tolerated, with minimal impact on weight and blood pressure, and a rate of adverse event-related discontinuations of 6.1% on TONMYA vs. 3.5% on placebo. The most common adverse events were mild and self-limited oral cavity reactions that rarely led to study withdrawal.. TONMYA 耐受性良好，对体重和血压的影响极小，与不良事件相关的停药率为6.1%（使用TONMYA）对比3.5%（使用安慰剂）。最常见的不良事件是轻微且自限性的口腔反应，很少导致研究退出。'TONMYA’S sublingual formulation largely bypasses first-pass hepatic metabolism, which reduces formation of norcyclobenzaprine, the persistent active metabolite that we believe otherwise interferes with the duration of the treatment effect,' said Dr. Sullivan. 'This results in a distinct pharmacokinetic profile compared to oral cyclobenzaprine, with greater relative bioavailability of the parent drug during sleep and reduced active metabolite exposure during daytime. “TONMYA的舌下含服制剂在很大程度上绕过了首过肝脏代谢，这减少了去甲环苯扎林（我们认为这种持久的活性代谢物会干扰治疗效果的持续时间）的形成，”沙利文博士说。“这导致了与口服环苯扎林相比不同的药代动力学特征，在睡眠期间母体药物的相对生物利用度更高，而在白天减少了活性代谢物的暴露。”Bedtime sublingual administration is also designed to target the non-restorative sleep that is central to fibromyalgia pathophysiology, translating to broad-spectrum activity across the core symptoms of fibromyalgia, including pain, sleep disturbance, and fatigue, with a favorable tolerability profile that may reduce the need for polypharmacy.'. 睡前舌下给药还旨在针对纤维肌痛病理生理学核心的非恢复性睡眠，转化为对纤维肌痛核心症状（包括疼痛、睡眠障碍和疲劳）的广谱作用，并具有良好的耐受性，可能减少多药联用的需求。TONMYA was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. It is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA 于 2025 年 8 月 15 日获得 FDA 批准，用于治疗成人纤维肌痛。这是 15 年多以来首个获批用于纤维肌痛的新处方药。Tonix Pharmaceuticals Holding Corp.* Tonix制药控股公司*Tonix is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYA™, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. Tonix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销售FDA批准的TONMYA™，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。TONMYA是FDA在过去15年中批准的首个用于纤维肌痛的新处方药。TONMYA was investigated as TNX-102 SL. Tonix also markets two treatments for acute migraine in adults: Zembrace. TONMYA 作为 TNX-102 SL 进行了研究。Tonix 还推出了两种针对成人急性偏头痛的治疗方法：Zembrace。® ®SymTouch 触摸符号® ®(sumatriptan injection) and Tosymra (sumatriptan注射剂) 和 Tosymra® ®(sumatriptan nasal spray). Tonix’s development portfolio* is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. （舒马普坦鼻喷雾剂）。Tonix公司的开发产品组合*专注于中枢神经系统（CNS）疾病、免疫学、免疫肿瘤学、罕见病和传染病。TNX-102 SL正在北卡罗来纳大学的OASIS研究中，根据研究者发起的IND，被开发用于治疗急性应激反应和急性应激障碍，该研究由美国资助。Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2- ready 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. 美国国防部 (DoD)。TNX-102 SL 也正在开发用于重度抑郁症。Tonix 的免疫学开发产品组合包括用于解决器官移植排斥、自身免疫和癌症的生物制剂，其中包括 TNX-1500，这是一种处于第二阶段的 Fc 改良人源化单克隆抗体，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 rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a Phase 2- ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Tonix的罕见病产品组合包括TNX-2900，一种添加镁强化的鼻腔催产素，正在开发用于普拉德-威利综合征，预计将于2026年开始一项潜在的关键性二期研究。Tonix的传染病产品组合包括TNX-801，一种正在开发用于猴痘和天花的疫苗，以及TNX-4800，一种处于二期临床阶段、用于季节性预防莱姆病的长效人源化单克隆抗体。Finally, 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, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. 最后，TNX-4200 是 Tonix 与美国国防部下属的国防威胁降低局 (DTRA) 签订的一份合同，金额高达 3400 万美元，合同期为五年。它是一种小分子广谱抗病毒剂，靶向 CD45，用于预防或治疗高致命性感染，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家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；其疗效和安全性尚未确定，也未获批准用于任何适应症。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 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. 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，包括与本次发行完成、惯例交割条件的满足、本次发行所得款项的预期用途及其他具有预测性质的陈述相关的声明。These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. 这些声明可以通过使用前瞻性词语来识别，例如“预期”、“相信”、“预测”、“估计”、“预计”和“打算”等。这些前瞻性声明基于Tonix的当前预期，实际结果可能因多种因素而存在重大差异，包括公司满足发行成交条件及其时间安排的能力，以及公司在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）和在该日期或之后向SEC提交的定期报告中描述的因素。Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.. Tonix 不承担更新或修改任何前瞻性声明的义务。Tonix 的所有前瞻性声明均明确受所有此类风险因素及其他警示声明的限制。本文提供的信息仅截至其日期有效。Investor Contact 投资者联系s sJessica 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@托尼克斯制药公司. com(862) 799-8599 (862) 799-8599Brian Korb 布莱恩·科尔布astr partners 天体伙伴(917) 653-5122 (917) 653-5122brian.korb@astrpartners.com brian.korb@astrpartners.comMedia Contacts 媒体联系人Ray Jordan 雷·乔丹Putnam Insights 普特南见解ray@putnaminsights.com 雷@普特南洞察力.com 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 禁忌：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. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. 对环苯扎林或TONMYA中的任何非活性成分过敏的患者禁用。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。如果怀疑出现过敏反应，请停止使用TONMYA。同时禁用于单胺氧化酶（MAO）抑制剂的合并使用，或在停用MAO抑制剂后的14天内。Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.. 接受环苯扎林（或结构相似的三环类抗抑郁药）与单胺氧化酶抑制剂药物同时治疗的患者中，已发生过高热危象、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. In patients with hyperthyroidism. 在心肌梗死的急性恢复期，以及在患有心律失常、心脏传导阻滞或传导障碍或充血性心力衰竭的患者中。在患有甲状腺功能亢进的患者中。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在受孕前两周和妊娠第一季度使用时可能会导致神经管缺陷。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，以排除在妊娠头三个月使用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）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. 血清素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。如果出现血清素综合征症状，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. 应开始进行对症治疗。If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases. 如果临床需要同时使用TONMYA和其他血清素类药物，建议密切观察，尤其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. 三环类抗抑郁药样的不良反应：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。如果出现有临床意义的中枢神经系统（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。有癫痫史的患者在使用TCA期间应进行监测，以发现癫痫复发或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：尿潴留、闭角型青光眼、眼内压升高病史的患者以及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。建议患者在合理确定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治疗的患者更频繁出现口腔黏膜不良反应。建议患者在使用TONMYA前喝水湿润口腔，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%，且在接受TONMYA治疗的患者中比接受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道。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、巴比妥类药物及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：这些药物的降血压作用可能会被阻断。USE IN SPECIFIC POPULATIONS 在特定人群中使用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. 怀孕：根据动物数据，TONMYA在给予孕妇时可能会对胎儿造成伤害。目前关于妊娠期口服环苯扎林的少量观察数据质量不足，无法充分说明TONMYA与重大出生缺陷、流产或不良母体及胎儿结果之间的相关风险。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).. 告知孕妇母体接触TONMYA可能对胎儿造成风险，并避免在受孕前两周及妊娠头三个月内使用TONMYA。向Tonix Medicines, Inc.的不良事件报告热线1-888-869-7633（1-888-TNXPMED）报告怀孕情况。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：少数已发表的病例报告称环苯扎林可少量转移到人乳中，但这些数据无法确认。尚无关于环苯扎林对哺乳婴儿的影响或对乳汁生成影响的数据。在考虑母亲对TONMYA的临床需求时，应权衡母乳喂养对发育和健康的益处，以及TONMYA或潜在母体状况对哺乳婴儿可能产生的任何不良影响。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的临床试验并未包括足够数量的65岁及以上的患者，因此无法确定他们是否与较年轻的成年患者反应不同。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，这可能会提高TONMYA相关不良反应的风险。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 January 30, 2026 发布日期：2026年1月30日
