Vistagen says FDA Type C feedback supports LSAS endpoint path for fasedienol Phase 3 in SAD

Vistagen Therapeutics, Inc.

FDA provided constructive feedback on Vistagen's proposed use of the Liebowitz Social Anxiety Scale (LSAS) as the primary endpoint in a future Phase 3 study in adults with SAD.
Vistagen plans to add interim assessments using eDiaries and qualitative patient surveys to the Phase 3 design, then submit a revised protocol to FDA.
FDA recognized fasedienol's reported safety profile and potential to benefit a broad SAD population; Vistagen will pursue overall, not just acute, treatment of SAD.
No Phase 3 start date, enrollment target, or financing amount was disclosed; Vistagen cited the need to secure sufficient financing to advance development.

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