Vistagen Intends To Adopt Incorporate Interim Assessments Of Fasedienol's Effect Through eDiaries, Qualitative Patient Surveys In Phase 3 Trial Design After Type C Meeting With FDA

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry, today announced a regulatory update from its recent, productive Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss potential registrational paths forward for the development of its lead product candidate, fasedienol, in social anxiety disorder (SAD).

Vistagen plans to incorporate interim assessments of fasedienol's effect using eDiaries and qualitative patient surveys in the future Phase 3 study design, and to submit a revised protocol to the FDA.