Thursday, April 13, 2017 3:14:56 PM
Tonix Pharmaceuticals Reports Results from U.S. FDA Initial Cross-Disciplinary Breakthrough Meeting on TNX-102 SL for Posttraumatic Stress Disorder
Registration of TNX-102 SL Could be Solely Supported by the Phase 3 HONOR Study if Topline Data are Statistically Persuasive
NEW YORK, April 11, 2017 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a company that is developing innovative pharmaceutical products to address public health challenges, announced today the receipt of official minutes from its Initial Cross-Disciplinary Breakthrough Meeting held with the U.S. Food and Drug Administration (FDA) on March 9, 2017. Upon being awarded Breakthrough Therapy designation in December 2016, Tonix was invited to meet with the FDA to evaluate the feasibility of accelerating the development and registration of TNX-102 SL* for the treatment of posttraumatic stress disorder (PTSD).
Seth Lederman, M.D., president and chief executive officer of Tonix, stated, “The FDA’s consideration of a single-study New Drug Application (NDA) and continued support of the Phase 3 HONOR study are critical to accelerating the availability of a potentially improved treatment option for PTSD patients, especially those patients with military-related PTSD. The FDA’s standard of evidence for drug approval typically requires two positive Phase 3 trials; however, following our Initial Cross-Disciplinary Breakthrough Meeting in March, the FDA confirmed a single-study NDA approval could be possible based on statistically persuasive topline data from the ongoing HONOR study. Additionally, due to the lack of evidence of potential abuse in clinical studies of TNX-102 SL, the FDA agreed that studies in assessing abuse potential of TNX-102 SL are not required to support the TNX-102 SL NDA.”
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