Vistagen Offers Hope to the 25M Americans Living with Social Anxiety Disorder

Vistagen (Nasdaq: VTGN) has reported positive topline results from its Phase 3 clinical trial evaluating a nasal spray treatment for adults with social anxiety disorder (SAD). Vistagen’s clinical trial is the first positive U.S. Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years.

 Shawn Singh, Chief Executive Officer of Vistagen, said, “We are thrilled that these compelling top-line results from the Phase 3 PALISADE-2 trial confirm what was seen in the Phase 2 studies in social anxiety disorder and highlight the potential for fasedienol, with its novel and unique proposed mechanism of action, to transform what is possible for more than 25 million people living with social anxiety in the U.S. and millions more affected worldwide.”

Highlights

PALISADE-2 was a multi-center, randomized, double-blind, placebo-controlled, Phase 3 clinical study in adults diagnosed with SAD. The study was designed to evaluate the efficacy, safety, and tolerability of the acute administration of fasedienol to relieve anxiety symptoms.

The trial met its primary and secondary endpoints, with fasedienol demonstrating a statistically significant difference in average Subjective Units of Distress Scale (SUDS) score during a public speaking challenge compared to placebo (p=0.015).

Fasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials of fasedienol in social anxiety disorder.

Fasedienol’s potential, as demonstrated in this Phase 3 trial, sets the stage for the first fundamentally new class of medicine for individuals living with SAD in more than 20 years.

About Vistagen

Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. Vistagen is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns, than those currently available for the treatment of anxiety, depression and multiple CNS disorders. Vistagen’s pipeline includes six clinical-stage product candidates, including fasedienol (PH94B), itruvone (PH10), PH15, PH80, and PH284, each an investigational agent belonging to a new class of drugs known as pherines, as well as AV-101, which is an oral prodrug antagonist of the N-methyl-D-aspartate receptor. Pherines are administered as low microgram dose level nasal sprays and are designed with a novel mechanism of action that activates chemosensory neurons in the nasal cavity and can beneficially impact key neural circuits in the brain without systemic uptake or direct activity on CNS neurons in the brain. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression and several other CNS disorders. Connect at www.vistagen.com.

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Vistagen Offers Hope to the 25M Americans Living with Social Anxiety Disorder

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