VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (“CNS”) diseases and disorders with high unmet need, today announced that it has received Fast Track designation U.S. Food and Drug Administration (“FDA”) for development of the company’s PH94B neuroactive nasal spray for on-demand treatment of social anxiety disorder (“SAD”). VistaGen is currently preparing PH94B for phase 3 development. “The FDA’s grant of Fast Track designation for development of PH94B for SAD, which to our knowledge is the FDA’s first Fast Track designation for a SAD drug candidate, is another important regulatory milestone for VistaGen and a key step forward in our development program for PH94B as a new generation anxiolytic. With a high global prevalence of anxiety disorders, including SAD, and alarming increases in dependency, addiction and even deaths associated with misuse of benzodiazepines, the urgency for a new non-addictive, non-sedating, fast-acting, as-needed treatment for SAD and other anxiety disorders is more important now than ever before. Based on clinical studies to date, PH94B, at non-systemic microgram doses, has strong potential to fill the large current treatment gap,” VistaGen Therapeutics CEO Shawn Singh stated in the news release.
To view the full press release, visit http://ibn.fm/TrXua
VistaGen Therapeutics is a clinical-stage biopharmaceutical company developing new generation medicines for CNS diseases and disorders where current treatments are inadequate, resulting in high unmet need. VistaGen’s pipeline is focused on clinical-stage CNS drug candidates with differentiated mechanisms of action, exceptional safety profiles in all clinical studies to date, and therapeutic potential in multiple large and growing CNS markets. For more information, visit the company’s website at www.Vistagen.com.
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