Vistagen's Fasedienol Phase 3 Trial Misses Primary Endpoint

Vistagen Therapeutics announced that its PALISADE-4 Phase 3 trial of fasedienol for acute social anxiety disorder did not achieve its primary endpoint. The trial, which used the Subjective Units of Distress Scale (SUDS) as the primary measure, showed no statistically significant improvement over placebo in the overall population. However, a post-hoc analysis of patients with very severe social anxiety disorder revealed a nominally statistically significant improvement. The company reported favorable safety and tolerability data and plans to engage with the FDA to discuss a new registrational pathway, potentially involving a single future Phase 3 trial with the Liebowitz Social Anxiety Scale (LSAS) as the primary endpoint.