FDA Grants Fast Track Designation to PH94B for Treatment of Social Anxiety Disorder

The FDA has granted Fast Track Designation for the development of PH94B (VistaGen Therapeutics), a neuroactive nasal spray for on-demand treatment of social anxiety disorder (SAD).

After a successful phase 2 development, PH94B is set for phase 3 development for SAD. If approved, PH94B has the potential to be the first fast-acting, non-sedating treatment for as many as 20 million individuals in the US who suffer from SAD.

A first-in-class, rapid-onset neuroactive nasal spray, PH94B is administered at microgram doses and triggers neural circuits in the brain that suppress fear and anxiety associated with everyday social and work or performance situations. The spray has additional potential in treating other conditions, such as peripartum anxiety, pre/postoperative anxiety, post-traumatic stress disorder, panic disorder, and generalized anxiety disorder.

Reference

US FDA grants VistaGen Therapeutics fast track designation for PH94B for treatment of social anxiety [news release]. South San Francisco, CA; VistaGen Therapeutics: December 10, 2019. https://www.vistagen.com/news-media/press-releases/detail/131/u-s-fda-grants-vistagen-therapeutics-fast-track. Accessed December 10, 2019.