Nasal spray to treat anxiety moves forward with global phase 3 trial

VistaGen Therapeutics and AffaMed Therapeutics announced a global phase 3 trial to assess the efficacy, safety and tolerability of a nasal spray that treats adults with social anxiety disorders.

Dubbed the PALISADE Global trial, the companies have submitted necessary data to the FDA under its existing PH94B investigational new drug application for the nasal spray. The trial is expected to begin in the United States and China in the second half of 2022.

PH94B is odorless, fast-acting neuroactive spray with a potential mechanism of action for the acute treatment of anxiety in adults.

“VistaGen remains committed to transforming the treatment of anxiety disorders for the millions of individuals worldwide who need better, safer, and faster-acting therapeutics in their journey toward mental health wellness,” VistaGen CEO Shawn Singh said in statement.

In June 2020, VistaGen entered into a licensing and collaboration agreement with AffaMed for the clinical development and commercialization of PH94B for those in China, South Korea and South Asia.

“We appreciate VistaGen’s essential work in the U.S. under its PH94B [investigational new drug] application with the FDA,” AffaMed CEO Dayao Zhao, PhD, said in the release. “We thank the [National Medical Products Association] for recognizing the importance of this phase 3 study and rapidly expediting the approval of our [clinical trial application]. We look forward to dosing participants later this year.”