Topline results expected late December 2023 RESILIENT is expected to be the final efficacy trial required for submission of a New Drug Application to FDA; first successful Phase 3 trial, RELIEF, achieved statistical significance (p=0.010) Preliminary unaudited rate of adverse-event (AE) related discontinuations in the RESILIENT study was 4.8% which compares favorably with prior studies: RELIEF 6.0% and RALLY 10.7% TNX-102 SL is a centrally acting, non-opioid analgesic CHATHAM, N.J., Nov.

预计2023年12月下旬的Topline结果弹性预计将成为向FDA提交新药申请所需的最终疗效试验；第一个成功的3期试验，RELIEF，达到统计学意义（p=0.010）弹性研究中初步未经审计的不良事件（AE）相关中断率为4.8%，与之前的研究相比有利：RELIEF 6.0%和RALLY 10.7%TNX-102 SL是一种中枢作用的非阿片类镇痛药CHATHAM，N.J.，Nov。

15, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical phase of the Phase 3 registration-quality, double-blind, placebo-controlled RESILIENT1 study of TNX-102 SL2 (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia.

152023（GLOBE NEWSWIRE）-Tonix Pharmaceuticals Holding Corp.（纳斯达克股票代码：TNXP）（Tonix或该公司），一家拥有销售产品和开发候选人管道的生物制药公司，今天宣布完成临床阶段第三阶段注册质量，双盲，TNX-102 SL2（盐酸环苯扎林舌下片）5.6 mg治疗纤维肌痛的安慰剂对照弹性研究。

A total of 457 patients were enrolled in this multi-site study in the U.S. Topline results are expected in late December 2023. If successful, it is expected to be the final, well-controlled efficacy trial required for submission of a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA).

共有457名患者参加了这项多地点研究，预计在2023年12月下旬美国的Topline结果。如果成功，预计这将是提交新药申请（NDA）以供美国食品和药物管理局（FDA）批准所需的最终的，控制良好的功效试验。

“There are an estimated 6-12 million individuals in the U.S. suffering from this debilitating condition, most of whom are women,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-102 SL is a centrally-acting, non-opioid analgesic bedtime medication designed to be used on a chronic basis for the management of fibromyalgia.

Tonix Pharmaceuticals首席执行官Seth Lederman博士说：“美国估计有600万至1200万人患有这种使人衰弱的疾病，其中大多数是女性。”。“TNX-102 SL是一种中枢作用的非阿片类镇痛睡前药物，旨在长期用于治疗纤维肌痛。

We believe TNX-102 SL works by improving sleep quality, which leads to improvement of other symptoms. In previous studies, TNX-102 SL showed broad coverage across the symptoms of fibromyalgia.

我们相信TNX-102 SL通过改善睡眠质量起作用，从而改善其他症状。在以前的研究中，TNX-102 SL显示纤维肌痛症状的广泛覆盖。