FDA Approves Fast Track Designation for Nasal Spray for Social Anxiety Disorder

December 12, 2019

The rapid-onset CNS neuroactive nasal spray is distributed to patients in microgram doses and activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety associated with everyday social, work, or performance situations.

VistaGen Therapeutics, a San Francisco, CA-based clinical-stage biopharmaceutical company focused on developing drugs for central nervous system (CNS) diseases and disorders, announced that FDA has granted fast track designation to the company’s PH94B neuroactive nasal spray for treatment of social anxiety disorder (SAD).

According to a Dec. 10, 2019 company press release, PH94B, a rapid-onset CNS neuroactive nasal spray, is distributed to patients in microgram doses and activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety associated with everyday social, work, or performance situations. After a successful Phase II development, the company is prepping the nasal spray for Phase III development, putting it on track to become the first fast-acting, non-sedating treatment for people with SAD in the United States, according to the company.

"[FDA's] grant of [f]ast [t]rack designation for development of PH94B for SAD, which to our knowledge is [FDA's] first [f]ast [t]rack 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,” said Shawn Singh, CEO of VistaGen, in the press release. “With a high global prevalence of anxiety disorders, including SAD, and alarming increase 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."

Source: VistaGen