Vistagen, a biopharmaceutical company based in South San Francisco, announced the results of its PALISADE-3 Phase 3 clinical trial for intranasal fasedienol, aimed at the acute treatment of social anxiety disorder. The study did not achieve its primary endpoint, as the data indicated no statistically significant improvement compared to a placebo.
In detail, the primary measure was the change in scores on the Subjective Units of Distress Scale (SUDS). The results showed a least squares (LS) mean change from baseline of 13.6 (±1.54 standard error, SE) for fasedienol, compared to 14.0 (±1.51 SE) for the placebo group. The LS mean difference of 0.4 was found to be not significant (p = not significant).
Study Findings and Safety Profile
Additionally, the trial’s secondary endpoints did not reveal any treatment differences between fasedienol and the placebo. Despite these outcomes, Vistagen reported that the safety profile of fasedienol was in line with data from previous clinical trials, suggesting that the treatment was well tolerated by participants.
The PALISADE-3 study marks an important step in Vistagen’s ongoing efforts to address social anxiety disorder, a condition that affects millions worldwide. While the results were disappointing regarding the primary efficacy measures, the company remains committed to exploring the potential of its pherine technology platform, which aims to deliver therapeutic compounds directly to the brain through intranasal administration.
As Vistagen moves forward, it will likely seek to analyze the data further and consider potential next steps in its clinical development program for fasedienol and other candidates. The company continues to focus on advancing neuroscience through innovative approaches to treatment.
