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Tonix Pharmaceuticals Completes Clinical Stage of Phase 3 RESILIENT Study of TNX-102 SL for the Management of Fibromyalgia
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;
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"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. 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. 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). “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. 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, including chronic widespread pain, fatigue and sleep disturbance.” “The preliminary unaudited rate of adverse-event (AE) related discontinuations in the RESILIENT study was 4.8%,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “This compares favorably to the blinded AE-related discontinuation rates in our two previous Phase 3 trials: 6.0% in RELIEF which achieved statistical significance on the primary endpoint (p=0.010), and 10.7% in RALLY which was stopped at the interim analysis. We later learned that an unexpectedly high rate of A...