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Tonix Pharmaceuticals Presents Positive Results from Phase 3 RELIEF Study of TNX-102 SL for the Management of Fibromyalgia at the 2021 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting
Confirmatory Phase 3 Study, RALLY, Ongoing with Interim Analysis Expected in Third Quarter 2021 CHATHAM, N.J., June 03, 2021 (GLOBE NEWSWIRE) -- Tonix
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Confirmatory Phase 3 Study, RALLY, Ongoing with Interim Analysis Expected in Third Quarter 2021\nCHATHAM, N.J., June 03, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the poster presentation of positive results from its Phase 3 clinical study, RELIEF, of TNX-102 SL for the management of fibromyalgia. A copy of the poster will be made available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com. The poster, titled, “Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Trial” shows 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) and was associated with a higher rate than placebo of ≥30% pain responders in participants with fibromyalgia (p=0.006). TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints measuring improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific functional recovery. In addition, TNX-102 SL was well tolerated and was not associated with side-effects seen with other approved oral fibromyalgia treatments, including weight gain, insomnia, nausea or sexual dysfunction. “We believe the results of the Phase 3 RELIEF trial validate the mechanism that improved sleep quality can lead to syndromal effects on fibromyalgia, improving not only pain but also sleep and fatigue. The sublingual formulation of TNX-102 SL for transmucosal absorption showed promise at the 2.8 mg dose in prior fibromyalgia studies, but we believe RELIEF provides evidence that 5.6 mg is the right dose for this patient population,” said Seth Lederman, M.D., President and Chief Executive Officer. “We expect interim analysis results for the confirmatory Phase 3 study, RALLY, in the third quarter of this year, followed by topline data in the first quarter of next year.” About Fibromyalgia Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% o...