VistaGen Gains Fast Track for SAD Drug

VistaGen Therapeutics, Inc., a clinical-stage biopharmaceutical company developing medicines for central nervous system (CNS) diseases, was granted Fast Track designation by the U.S. FDA for the company’s PH94B neuroactive nasal spray for on-demand treatment of social anxiety disorder (SAD).

The FDA’s Fast Track process is designed to facilitate the development and review of new treatments for serious conditions with unmet medical need, with the goal of getting new treatment options to patients sooner. After successful Phase II development, VistaGen is preparing PH94B for Phase III development. PH94B has potential to be the first fast-acting, non-sedating, as-needed treatment for as many as 20 million individuals in the U.S. suffering from SAD. 

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