VistaGen Therapeutics has announced that its PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD) has received Fast Track designation from the FDA. The company says that it is preparing to conduct Phase 3 trials of the nasal spray.
In September 2018, VistaGen announced that it had acquired exclusive global rights to PH94B from Pherin Pharmaceuticals. Earlier this year, the company presented new data from a 2015 Phase 3 trial of PH94B.
VistaGen CEO Shawn Singh said, “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.”
Read the VistaGen press release.
