VistaGen Therapeutics, Inc. (NASDAQ: VTGN) Moves Forward in Developing As-Needed Treatment for Social Anxiety Disorder

• Company signs a worldwide licensing agreement with Pherin Pharmaceuticals for the development and commercialization of a Phase 3-ready CNS drug candidate for as-needed treatment of social anxiety disorder
• Untreated social anxiety disorder has a significant impact on a person’s overall quality of life
• Clinical studies support the potential of PH94B to be a superior treatment alternative for SAD due to the demonstrated rapid onset of efficacy, route of administration, as-needed dosing convenience and excellent safety profile

VistaGen Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage biopharmaceutical company developing new generation medicines for depression and other central nervous system (CNS) diseases and disorders with high unmet need. The company recently announced (http://ibn.fm/d4viI) that it has signed a license with Pherin Pharmaceuticals, Inc., a biopharmaceutical company focused on developing novel treatments for neuropsychiatric and neuroendocrine conditions, for exclusive worldwide rights of a Phase 3-ready CNS drug candidate for as-needed treatment of social anxiety disorder.

An estimated 15 million American adults are affected by social anxiety disorder, also called social phobia or SAD. It is the third most common psychiatric condition, following depression and substance use, and generally precedes other disorders. A person suffering from SAD may have unrealistic fears of one or more social or performance situations that may have a significant impact on the person’s employment, social activities and overall quality of life.

Antidepressants are a common treatment for SAD but have a slow onset that may take several weeks to work, have numerous side effects and must be taken consistently over a long period of time. At this time, there is no FDA-approved treatment that provides rapid relief.

VistaGen has acquired exclusive worldwide rights from Pherin to develop and commercialize PH94B nasal spray, a Phase 3-ready drug candidate for as-needed treatment of social anxiety disorder, to address this problem. In a news release, Shawn Singh, CEO of VTGN, stated, “We are excited to be working with Pherin’s innovative team to develop and commercialize this medically and socially impactful treatment. Our key objective for the PH94B program is to commence our initial pivotal Phase 3 clinical trial of PH94B nasal spray for SAD during the first half of 2019.”

The PH94B nasal spray utilizes Pherin’s first-in-class proprietary compounds called pherines. These synthetic neuroactive steroids engage chemosensory receptors inhibiting nerve circuits, mediating behavioral and physiological effects of anxiety. By engaging receptors in the nasal passage, pherines are rapidly effective in low quantities. The onset of results provides an excellent safety profile with greater patient convenience. Previous clinical trials of PH94B provided evidence of rapid (10-15 minutes) anxiety reduction of subjects with SAD and no adverse events with the nasal spray administration.

“This agreement provides a meaningful opportunity to continue our clinical progress and advance our mission to bring novel treatment alternatives to the many individuals affected with SAD,” added Dr. Louis Monti, executive vice president of Pherin, “Our prior clinical studies support the potential of PH94B to be a superior treatment alternative for SAD due to the demonstrated rapid onset of efficacy, route of administration, as-needed dosing convenience, and excellent safety profile compared to other existing therapeutic options which require chronic dosing and have concurrent side effects.”

VistaGen has also acquired an option from Pherin to license an additional CNS neuropsychiatry-focused product now in Phase 2 development.

For more information, visit the company’s website at www.VistaGen.com

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