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Tonix Pharmaceuticals Announces Publication of Results from Phase 3 RELIEF Trial of TNX-102 SL for the Management of Fibromyalgia
Previously Disclosed Data Demonstrated that TNX-102 SL Achieved Statistically Significant Pain Reduction Over Placebo at Week 14 (Primary Endpoint, p=0.01)
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Previously Disclosed Data Demonstrated that TNX-102 SL Achieved Statistically Significant Pain Reduction Over Placebo at Week 14 (Primary Endpoint, p=0.01) and Was Generally Safe and Well Tolerated Topline Data from RESILIENT, a Potentially Confirmatory Registration-Enabling Phase 3 Fibromyalgia Trial of TNX-102 SL, Expected Fourth Quarter 2023 CHATHAM, N.J., June 15, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that previously disclosed results from the Phase 3 RELIEF study of TNX-102 SL for the management of fibromyalgia have been published in the peer-reviewed journal Arthritis Care & Research, an official journal of the American College of Rheumatology. In RELIEF, treatment with TNX-102 SL was associated with significant reductions in daily pain and was generally safe and well tolerated in patients with fibromyalgia. Secondary results also suggest that treatment with TNX-102 SL can improve sleep and reduce fatigue, which together with pain are recognized as core fibromyalgia symptoms. TNX-102 SL is a novel, non-opioid, centrally-acting analgesic, intended to be taken once daily at bedtime. The paper can be accessed online at https://pubmed.ncbi.nlm.nih.gov/37165930/. “There continues to be a pressing need for novel, safe and more tolerable drugs to treat patients with fibromyalgia, a debilitating chronic disease that afflicts an estimated 6 to 12 million adults in the United States, with symptoms including multisite pain and disturbed sleep,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Current fibromyalgia therapies have limited efficacy in alleviating symptoms of sleep disturbance and fatigue. These Phase 3 RELIEF data suggest that treatment with TNX-102 SL may improve sleep quality and fatigue in patients with fibromyalgia, in addition to reducing pain.” The paper, titled, “Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia: Results From the Randomized, Placebo Controlled RELIEF Trial,” includes data demonstrating 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, in an exploratory analysis, when the primary endpoint was...