Shares of Tonix Pharmaceuticals (NASDAQ: TNXP) are up 12% this morning on news that the company has received official minutes from its Initial Cross-Disciplinary Breakthrough Meeting held with the U.S. Food and Drug Administration (FDA) on March 9, 2017. After 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). “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,” president and CEO Seth Lederman, M.D., stated in the news release.
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About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative pharmaceutical products to address public health challenges. TNX-102 SL is in phase 3 development and has been granted Breakthrough Therapy designation by the FDA for the treatment of PTSD. PTSD is a serious condition characterized by chronic disability, inadequate treatment options especially for military-related PTSD, and an overall high utilization of healthcare services that contributes to significant economic burdens. The Protectic™ protective eutectic and Angstro-Technology™ formulation are essential elements of the proprietary TNX-102 SL composition for which a Notice of Allowance has been issued by the U.S. Patent and Trademark Office. Other development efforts include TNX-601 (tianeptine oxalate), a clinical candidate at Pre-IND (Investigational New Drug) application stage, designed for daytime use for the treatment of PTSD, and TNX-801, a potential smallpox-preventing vaccine based on a live synthetic version of horsepox virus. Further information about Tonix can be found at www.tonixpharma.com.
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