Vistagen initiates Phase 3 fasedienol trial for SAD treatment

Vistagen announced that it has enrolled the first patient in its PALISADE-3 Phase 3 trial of fasedienol, an investigational pherine candidate in development for the acute treatment of social anxiety disorder SAD . “Initiating Study of Fasedienol for the is another major milestone in our plan to develop and commercialize fasedienol as the first treatment of its kind for social anxiety disorder,” said Shawn Singh, Chief Executive Officer. “We look forward to initiating PALISADE-4 in the second half of this year and advancing our innovative pherine pipeline to deliver pioneering neuroscience to patients affected by mental health disorders and unsatisfied with current treatments.” PALISADE-3, similar to PALISADE-2, is a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the efficacy, safety, and tolerability of the acute administration of fasedienol to relieve anxiety symptoms in patients with SAD induced by a public speaking challenge conducted in a clinical setting. …The U.S. FDA has granted Fast Track designation for the investigation of fasedienol for the acute treatment of SAD.