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Tonix Pharmaceuticals Presents Positive Efficacy and Safety Data from Phase 3 RELIEF Study of TNX-102 SL for the Management of Fibromyalgia at the 5th International Congress on Controversies in Fibromyalgia
Interim Analysis of RESILIENT, a Potentially Confirmatory Registration-Enabling Phase 3 Fibromyalgia Trial of TNX-102 SL Expected Second Quarter 2023; Topline
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Interim Analysis of RESILIENT, a Potentially Confirmatory Registration-Enabling Phase 3 Fibromyalgia Trial of TNX-102 SL Expected Second Quarter 2023; Topline Data Expected Fourth Quarter 2023\nCHATHAM, N.J., March 30, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present an oral presentation and poster at the 5th International Congress on Controversies in Fibromyalgia being held March 30-31, 2023 at the Austria Trend Hotel Savoyen Vienna in Vienna, Austria. The presentation will take place today, Thursday, March 30, 2023 at 5:10-5:20 p.m. CET. The presentation, titled, “Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia: Results from the Randomized, Placebo Controlled RELIEF Trial” reports that TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia. Also, when the primary endpoint was analyzed as a ≥30% pain responder analysis, there was a higher rate of responders to TNX-102 SL (47%) than to placebo (35%; p=0.006). TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints demonstrating improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific global symptomatic and functional recovery. Early discontinuation rates were similar for TNX-102 SL and placebo (17.7% and 16.5%, respectively). In addition, TNX-102 SL was well tolerated with the most common adverse event from active treatment being oral numbness or hypoaesthesia, an administration site reaction that is typically transient, was never rated as severe, and only lead to one discontinuation. “There continues to be a pressing need for new, safe and more tolerable drugs to treat patients with fibromyalgia,” said Dr. Lederman. “We are looking forward to the results of a planned interim analysis due next quarter for our RESILIENT study, a potentially pivotal confirmatory Phase 3 study of TNX-102 SL for the management of fibromyalgia.” Copies of the presentation and poster are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com. In addition to the presentati...