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Vistagen Therapeutics announced preliminary positive data from the open-label extension (OLE) of its PALISADE-4 Phase…
VTGNVistagen Therapeutics, Inc.
Vistagen Therapeutics announced preliminary positive data from the open-label extension (OLE) of its PALISADE-4 Phase 3 study evaluating fasedienol for social anxiety disorder. The safety population included 322 subjects who used the nasal spray as needed up to six times daily for up to 12 months. Treatment was well-tolerated with no new drug-related safety findings and a discontinuation rate due to adverse events of only 1.6%. Exploratory efficacy data over four months showed clinically relevant improvements on both clinician-administered (LSAS) and patient-reported (SPIN) scales, with LSAS scores improving by up to 31.4 points at Month 4. The company plans to meet with the FDA in the current quarter regarding a potential New Drug Application for fasedienol. Vistagen Therapeutics is a late clinical-stage biopharmaceutical company developing intranasal neurocircuitry-focused product candidates.