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VistaGen Therapeutics Announces Positive Meeting with FDA Regarding Pivotal Phase 3 Study of PH94B for Acute Treatment of Anxiety in Patients with Social Anxiety Disorder
Company Reaches Consensus with FDA on Key Aspects of Novel Pivotal Phase 3 Study Agency Guidance May Provide Significant Time- and Cost-Efficiency for Phase 3
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"Company Reaches Consensus with FDA on Key Aspects of Novel Pivotal Phase 3 Study\n Agency Guidance May Provide Significant Time- and Cost-Efficiency for Phase 3 Program\n Approximately 17 Million American Adults Suffer from Social Anxiety Disorder\n\n\nSOUTH SAN FRANCISCO, Calif., July 23, 2020 /PRNewswire/ -- VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) disorders, announced the results of a positive meeting with the U.S. Food and Drug Administration (FDA) regarding Phase 3 development of PH94B for the acute treatment of anxiety in adult patients with social anxiety disorder (SAD). \n\n \n \n \n \n \n \n\n \nVistaGen and the FDA reached consensus on key aspects of a unique initial pivotal Phase 3 clinical trial of PH94B involving a single-event, laboratory-simulated public speaking challenge in adult patients with SAD. \nPH94B is an investigational rapid-onset neurosteroid nasal spray that is fundamentally differentiated from all FDA-approved treatments for anxiety disorders. According to the U.S. National Institute of Mental Health (NIMH), there are approximately 17 million adults in the U.S. with SAD.\n\"Much like a rescue inhaler is used in an asthma attack or a migraine drug is used in an acute migraine episode, PH94B is a potential fit for the acute treatment of anxiety symptoms in anticipation of an often predictable, anxiety-provoking situation for individuals suffering from SAD,\" said Shawn Singh, Chief Executive Officer of VistaGen. \n\"Notably, the FDA concurred that our initial pivotal Phase 3 efficacy study may be conducted in a manner substantially similar to the highly statistically significant Phase 2 study of PH94B, which study involved a single event, laboratory-simulated public speaking challenge in adult patients with SAD. The FDA's specific guidance will enable us to simplify the process of assessing efficacy among SAD patients in our Phase 3 studies and contribute to significant time- and cost-efficiency in the clinic,\" Singh added.\nKey Aspects of Consensus with FDA Regarding the Initial Pivotal Phase 3 Study of PH94B \nVistaGen's initial pivotal Phase 3 study of PH94B for acute treatment of anxiety in adult patients with SAD will be a randomized, double-blind, placebo-controlled, parall...