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Tonix Pharmaceuticals Achieves 50 Percent Enrollment in Phase 3 RELIEF Study of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) for Management of Fibromyalgia
Enrollment Continues in Phase 3 RELIEF Study, with Interim Results of the First 50 Percent of Participants Expected in September 2020 Topline Results of
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Enrollment Continues in Phase 3 RELIEF Study, with Interim Results of the First 50 Percent of Participants Expected in September 2020\n Topline Results of Approximately 470 Participants with Fibromyalgia Expected in the First Quarter of 2021 NEW YORK, April 24, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that 50 percent of the planned total number of participants have been randomized in the Phase 3 RELIEF trial, a potential pivotal study of TNX-102 SL* (cyclobenzaprine HCl sublingual tablets) 5.6 mg, a non-opioid, centrally acting analgesic, taken daily at bedtime for the management of fibromyalgia. An interim analysis of the first 50 percent of randomized participants will be conducted shortly after the 12-week treatment period has been completed by these participants. Pending approval of the interim statistical analysis plan by the U.S. Food and Drug Administration (FDA), results from the interim analysis are expected in September 2020. The interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) which will review the unblinded data and make one of four recommendations: (1) stop the study for success; (2) continue to enroll the full study as planned; (3) continue to enroll with a specified increase in the total number of participants in the full study; or (4) stop the study for futility. The COVID-19 pandemic may lead to a delay in data monitoring activities or reduced ability of participants or sites to complete study visits which could delay the interim analysis. The COVID-19 pandemic may also lead to a delay in recruitment of the second 50% of participants and topline results, but to date trial enrollment remains on schedule. “TNX-102 SL is a potential new, non-opioid, non-addictive analgesic that has been shown to have activity at a syndromal level, improving a broad array of fibromyalgia symptoms in prior Phase 2 and Phase 3 studies at the 2.8 mg dose,” said Seth Lederman, M.D., President and Chief Executive Officer. “If the final results from this study are positive, we believe that TNX-102 SL could provide a distinct mechanism from available pharmacotherapies that makes a significant difference in the lives of patients with fibromyalgia.” Supported by the previous safety and ef...