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Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting
Poster presentation highlighted results from confirmatory Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine HCl) treatment demonstrating
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Poster presentation highlighted results from confirmatory Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine HCl) treatment demonstrating statistically significant improvement in primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality New Drug Application (NDA) submitted to FDA in October 2024; Fast Track designation previously granted by FDA; FDA decision on approval expected 2025 TNX-102 SL is a potential non-opioid analgesic targeting non-restorative sleep If approved by FDA, TNX-102 SL would be the first member of a new class of analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years CHATHAM, N.J., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented data in a poster presentation at the ACR Convergence 2024 Annual Meeting, held November 14-19, 2024, in Washington, D.C. A copy of the Company’s presentation, titled “Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Fibromyalgia” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com. In the Phase 3 RESILIENT study, TNX-102 SL met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia. In the RESILIENT study, TNX-102 SL demonstrated a broad spectrum of benefits with statistically significant improvement in all six pre-specified key secondary endpoints including those related to improved sleep quality, reduced fatigue, and improved patient global ratings and overall fibromyalgia symptoms and function. TNX-102 SL was generally well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed. “Fibromyalgia is the prototypic nociplastic syndrome and one of the chronic overlapping pain conditions (COPCs)1,2,3,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-102 SL, designed as a bedtime treatment to target non-restorative sleep, has shown a statistically significant improvement in pain in two phase 3 studies. We b...