VistaGen Therapeutics Announces Positive Meeting With FDA Regarding Pivotal Phase 3 Study Of PH94B For Acute Treatment Of Anxiety In Patients With Social Anxiety Disorder

Key Aspects of Consensus with FDA Regarding the Initial Pivotal Phase 3 Study of PH94B

VistaGen's initial pivotal Phase 3 study of PH94B for acute treatment of anxiety in adult patients with SAD will be a randomized, double-blind, placebo-controlled, parallel comparison study conducted at approximately 12 to 15 sites in North America.

Dr. Michael Liebowitz, Professor of Clinical Psychiatry at Columbia University, director of the Medical Research Network in New York City, and creator of the Liebowitz Social Anxiety Scale (LSAS), will be the Principal Investigator of the study. Target enrollment will be approximately 182 adult patients with SAD.

As in the successful Phase 2 study of PH94B in SAD, the study will involve a single laboratory-simulated anxiety-provoking public speaking challenge. The Subjective Units of Distress Scale (SUDS) will be used to assess the primary efficacy endpoint in the study.

About PH94B

PH94B is a first-in-class, odorless, rapid-onset (within approximately 15 minutes) synthetic neurosteroid nasal spray with therapeutic potential across a broad range of anxiety-related disorders. Easily self-administered in microgram-level doses, PH94B does not require systemic uptake and distribution to produce its rapid-onset anti-anxiety effects.

VistaGen is preparing for Phase 3 clinical development of PH94B as a potential new generation fast-acting, non-sedating, non-addictive acute treatment of anxiety in adults with social anxiety disorder (SAD). The FDA has granted Fast Track designation for development of PH94B for this indication, the first such designation by the FDA for a drug candidate for SAD.

With its rapid-onset pharmacology, lack of systemic exposure and excellent safety profile in earlier studies, PH94B has potential as a novel treatment for multiple anxiety-related disorders. VistaGen is also preparing for Phase 2A development of PH94B for adjustment disorder related to the diverse impact of the COVID-19 pandemic. View more background information on SAD and a video on PH94B's mechanism of action.

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Susan Miller 7 months ago Member's comment

I wish these things were written so the lay person could understand them.