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Tonix Pharmaceuticals Completes Pre-IND Meeting with FDA for TNX-102 SL as a Clinical Candidate for Alcohol Use Disorder
FDA Official Meeting Minutes Support Tonix’s Plan to file an Investigational New Drug (IND) Application in the First Quarter of 2020 for a Phase 2
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"FDA Official Meeting Minutes Support Tonix’s Plan to file an Investigational New Drug (IND) Application in the First Quarter of 2020 for a Phase 2 Proof-of-Concept Study\nNEW YORK, Nov. 20, 2019 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it has received the official meeting minutes from a recent Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA). The FDA provided guidance and feedback supportive of Tonix’s clinical development plans for TNX-102 SL* as a potential treatment for alcohol use disorder (AUD). Based on this feedback, Tonix plans to submit an IND application in the first quarter of 2020 to support a Phase 2 proof-of-concept study.\n “An estimated 36 million adults in the United States have AUD, a chronic relapsing brain disease characterized by compulsive alcohol use, loss of control over alcohol intake, and a negative emotional state when not using alcohol,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix. “We believe that by improving sleep quality, the rate of successful recovery for people with AUD after detox can be improved.” Seth Lederman, M.D., President and Chief Executive Officer of Tonix, stated, “Subsequent to potentially receiving clearance for the IND application for AUD, Tonix expects to have four active IND’s for its lead compound TNX-102 SL, including posttraumatic stress disorder (PTSD), fibromyalgia and agitation in Alzheimer’s disease. TNX-102 SL is in Phase 3 development for PTSD, for which interim and topline results are expected next year, as well as for fibromyalgia. TNX-102 SL is Phase 2 ready as a treatment for agitation in Alzheimer’s disease.” About Tonix Pharmaceuticals Holding Corp. Tonix is a clinical-stage biopharmaceutical company focused on discovering and developing small molecules and biologics to treat psychiatric, pain and addiction conditions. Tonix’s lead product candidate, TNX-102 SL, is in development for posttraumatic stress disorder (PTSD), fibromyalgia, agitation in Alzheimer’s disease and alcohol use disorder (AUD). TNX-102 SL is in Phase 3 development as a bedtime treatment for PTSD (trade name Tonmya**) and fibromyalgia. The Phase 3 RECOVERY trial (P302) in PTSD is currently enrolling and results from an interim analysis are expe...