The U.S. Food and Drug Administration granted the fast-track designation to VistaGen Therapeutics Inc.'s nasal spray PH94B.
The company was evaluating PH94B as a treatment that is nonaddictive, nonsedating and can be taken as and when needed, VistaGen said, adding that the company is preparing for PH94B's phase 3 trials. The South San Francisco, Calif.-based biopharmaceutical company's treatment is aimed at treating social anxiety disorder.
Fast-track designation gives regulatory priority to treatments that show promise, including frequent meetings with the FDA and priority review of the marketing application.
VistaGen also has a depression medicine, called AV-101, which has failed two mid-stage studies.