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Vistagen Initiates Fasedienol Repeat Dose Study for the Acute Treatment of Social Anxiety Disorder
All planned clinical studies in fasedienol U.S. registration-directed Phase 3 program for the acute treatment of social anxiety disorder are underway SOUTH
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"\nAll planned clinical studies in fasedienol U.S. registration-directed Phase 3 program for the acute treatment of social anxiety disorder are underway\n\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nVistagen (Nasdaq: VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced enrollment of the first subject in a repeat dose study of fasedienol, its investigational neuroactive pherine nasal spray in Phase 3 development for the acute treatment of social anxiety disorder (SAD).\n\n\nThe repeat dose study is a small exploratory U.S. Phase 2 multi-center, randomized, double-blind, placebo-controlled, three-arm clinical trial designed to assess the efficacy, safety, and tolerability of a repeat dose of fasedienol (3.2 micrograms) in adults with SAD during a public speaking challenge conducted in a clinical setting. The three dosing arms will be fasedienol followed by fasedienol (total 6.4 micrograms), fasedienol followed by placebo (total 3.2 micrograms), and placebo followed by placebo, with the second dose in each arm administered ten minutes after the initial dose. Other than the repeat dose and the additional study arm, the study is similar in design to the ongoing PALISADE Phase 3 studies for the acute treatment of adults with SAD, including an open-label extension.\n\n\n\"The initiation of this fasedienol repeat dose study marks another significant milestone in our U.S. Phase 3 program for the acute treatment of social anxiety disorder,” said Shawn Singh, President and Chief Executive Officer of Vistagen. “With the increasing prevalence of social anxiety disorder over decades, millions of individuals in the U.S. live with debilitating acute fear and anxiety in everyday social situations without any U.S. FDA-approved acute treatment option. Our mission and PALISADE Phase 3 program for fasedienol are focused on changing that.\"\n\n\nAbout Vistagen’s U.S. Registration-directed PALISADE Phase 3 Program for Fasedienol for the Acute Treatment of Social Anxiety Disorder\n\n\nComplementing its statistically significant PALISADE-2 U.S. Phase 3 trial of fasedienol for the acute treatment of adults with SAD reported in 2023, Vistagen's U.S. registration-directed PALISADE Phase 3 program for fasedienol for the acute treatment of SAD includes its ongoing PALISADE-3 a...