Vistagen Announces Its Data From PALISADE-3 Phase 3 Trial Of Fasedienol Demonstrates Well-Toleration, No Drug-Related Safety Concerns

Vistagen (NASDAQ:VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced preliminary positive data from the ongoing open-label extension (OLE) portion of its PALISADE-3 Phase 3 study of fasedienol for the acute treatment of social anxiety disorder.

In a recent analysis of subjects who elected to participate in the OLE portion of PALISADE-3 (safety population: n=341), administration of 3.2 µg of fasedienol – taken as needed, up to six times per day in real-world, anxiety-provoking situations in daily life for up to 12 months – has been well-tolerated, with no new drug-related safety findings or trends identified. Exploratory efficacy data over the first four months of treatment demonstrated a clinically relevant improvement over time on both the clinician-administered Liebowitz Social Anxiety Scale (LSAS) and the Social Phobia Inventory (SPIN).