Vistagen Inc.
(NASDAQ:VTGN) on Monday reported that its Phase 3 PALISADE-4 trial of intranasal fasedienol for the acute treatment of social anxiety disorder did not meet its primary endpoint in the overall study population.
However, the company identified a statistically significant benefit in a post-hoc analysis of patients with very severe social anxiety and now plans to pursue a revised regulatory strategy focused on long-term treatment.
Read Also: Helus Pharma Stock Tumbles As Anxiety Drug Study Disappoints PALISADE-4 Misses Primary And Secondary Endpoints The trial enrolled 238 participants and used the Subjective Units of Distress Scale (SUDS) as its primary endpoint.
Fasedienol produced a least squares mean change from baseline of -9.5 compared with -11.4 for placebo, resulting in a difference of 1.9 that was not statistically significant (p=0.427).
