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Vistagen Initiates PALISADE-4 Phase 3 Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder
Next step in registration-directed PALISADE Phase 3 program for fasedienol in social anxiety disorder achieved as planned SOUTH SAN FRANCISCO,
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"\nNext step in registration-directed PALISADE Phase 3 program for fasedienol in social anxiety disorder achieved as planned\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nVistagen (Nasdaq: VTGN) a late clinical-stage neuroscience-focused biopharmaceutical company dedicated to the development and commercialization of groundbreaking therapies for psychiatric and neurological disorders based on nose-to-brain neurocircuitry, today announced enrollment of the first subject in its PALISADE-4 Phase 3 trial of fasedienol, an investigational neuroactive pherine nasal spray in U.S. registration-directed Phase 3 development for the acute treatment of social anxiety disorder (SAD).\n\n“With the initiation of PALISADE-4 as planned, we have achieved another important milestone in our registration-directed PALISADE Phase 3 program for fasedienol, which has potential to deliver a transformative acute treatment option to over 30 million Americans suffering from the debilitating effects of SAD, including increased risk for depression, alcohol abuse, and suicide attempts,” said Shawn Singh, Chief Executive Officer of Vistagen. “Current pharmacological therapies approved by the U.S. FDA do not include an acute treatment option. With pioneering neuroscience, we are breaking new ground in the development of a treatment for SAD with our novel product candidate designed for non-systemic, rapid activation of nose-to-brain neural circuits to reduce fear and anxiety associated with SAD.”\n\nAbout Vistagen’s PALISADE Phase 3 Program for Fasedienol for the Acute Treatment of SAD\n\nVistagen's U.S. registration-directed PALISADE Phase 3 development program for fasedienol for the acute treatment of SAD includes the ongoing PALISADE-3 and PALISADE-4 Phase 3 trials, each a randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the efficacy, safety, and tolerability of the acute administration of fasedienol to relieve anxiety symptoms in subjects with SAD induced by a public speaking challenge conducted in a clinical setting. PALISADE-3 and PALISADE-4 are designed similarly to Vistagen’s PALISADE-2 Phase 3 trial of fasedienol, from which positive data was reported last year. The primary outcome measure in each of the PALISADE Phase 3 trials is a subject’s self-rated Subjective Units of Distress Scale (SUDS). Similar to PALISADE-3 in...