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Tonix Pharmaceuticals Completes Enrollment in Phase 3 RELIEF Trial of TNX-102 SL for Management of Fibromyalgia
Target Enrollment Completed Ahead of Schedule Topline Data Expected Fourth Quarter 2020 Results of Interim Analysis from the First 50 Percent of Participants
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Target Enrollment Completed Ahead of Schedule\n Topline Data Expected Fourth Quarter 2020 Results of Interim Analysis from the First 50 Percent of Participants Expected in September 2020 NEW YORK, July 10, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has met its target enrollment of approximately 470 participants in its Phase 3 RELIEF trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, ahead of schedule. TNX-102 SL is in development as a non-opioid, centrally acting analgesic, taken daily at bedtime for the management of fibromyalgia. An optional interim analysis is expected in September 2020 of the first 50 percent of randomized participants evaluable for efficacy, with Independent Data Monitoring Committee recommendations based on the results, including sample size readjustment. Topline data is expected in the fourth quarter of 2020 based on the current sample size. “The completion of enrollment in our Phase 3 RELIEF trial is a significant accomplishment for Tonix as well as for the fibromyalgia community, and we look forward to announcing topline results, expected in the fourth quarter of this year,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We are developing a new, non-addictive treatment option for fibromyalgia because there are still inadequate therapy options for this disorder despite its prevalence as one of the most common chronic pain conditions.” About the Phase 3 RELIEF Study The RELIEF study is a double-blind, randomized, placebo-controlled adaptive design trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg in fibromyalgia. The trial targeted enrollment of approximately 470 participants across approximately 40 U.S. sites. For the first two weeks of treatment, there is a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. After the first two weeks, all participants have the dose increased to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for 12 weeks. The primary endpoint is daily diary pain severity score change from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures wit...