Vistagen receives FDA fast track for nasal spray for major depressive disorder

The FDA has granted Vistagen fast track designation for PH10, a nasal spray for the treatment of major depressive disorder, according to a company press release.

Vistagen is a late-stage biopharmaceutical company aiming to transform treatment for individuals with depression, anxiety and other central nervous symptoms disorders.

The FDA’s fast track program focuses on the development and review of new drugs for the treatment of life-threatening conditions and bringing new medicines to patients sooner.

“Vistagen is laser focused on bringing an innovative treatment option to individuals suffering with debilitating depression,” Vistagen CEO Shawn Singh said in the release. “The FDA’s grant of the fast track designation for the development of PH10 in major depressive disorder is a significant regulatory milestone, aligned with our belief in PH10’s potential to improve the standard of care in a significant market where new and differentiated treatments are urgently needed.”

According to the press release, the FDA was informed by the company’s nonclinical studies and three prior clinical studies of PH10, including a randomized, placebo-controlled, double-blind phase 2 clinical trial, which found that the spray did not cause psychological side effects and was well-tolerated by patients.

“Nearly two-thirds of diagnosed and treated depression patients do not achieve remission with a first line therapy,” Singh said. “With 21 million adults in the U.S. suffering at least one major depressive episode in the past year, potentially millions of individuals are not getting the help they need. We look forward to working with the FDA’s fast track program as we advance development of PH10 in the U.S.”