Vistagen Getting 'Back On Offense’ After US FDA Okays Endpoint For Its Social Anxiety Drug

CEO Shawn Singh discusses path forward for fasedienol (PH94B) using the classic LSAS primary endpoint in next clinical trial. Pherine nasal spray candidate failed to meet the primary endpoint (the patient-reported SUDS) in its first pivotal Phase III study, whose design was constrained by the Covid pandemic.

startup on track
Vistagen believes it is on track to begin a pivotal Phase III trial for its lead drug candidate • Source: Shutterstock

VistaGen Therapeutics, Inc. suffered a significant setback last year when its lead drug candidate fasedienol (PH94B) for treatment of social anxiety disorder failed to meet the primary endpoint in the product’s first Phase III clinical trial. But the company is optimistic that another trial with a different primary endpoint that has been accepted by the US Food and Drug Administration will be successful and support the filing of a new drug application.

Vistagen CEO Shawn Singh discussed the challenges with the first trial and the company’s plans going forward in an interview with the Pink Sheet in New York City last month

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