VistaGen Therapeutics has announced the initiation of the PALISADE-1 Phase 3 clinical trial of PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). PH94B was granted Fast Track designation for that indication in December 2019. In July 2020, the company announced details of the proposed trial, which is expected to enroll approximately 200 subjects.
The PALISADE-1 trial will use the same type of public speaking challenge used in a Phase 2 study of the nasal spray for SAD that was initiated in 2008 by Pherin Pharmaceuticals; Pherin licensed the nasal spray to VistaGen in 2018. VistaGen said that it expects topline data from the new Phase 3 trial to be available in mid-2022.
VistaGen CEO Shawn Singh said, “Initiation of PALISADE-1 is a major milestone for our PALISADE Phase 3 clinical program for PH94B, a program aimed at supporting a potential New Drug Application to the FDA. The trial is an essential next step in our efforts to confirm the positive efficacy and safety results we have seen in all PH94B Phase 2 trials to date. PH94B has the potential to be a life-changing acute, as-needed treatment of anxiety for adults with SAD, similar to how a rescue inhaler is used to prevent an asthma attack. At a time of continuing increase in the number of Americans suffering from SAD and other anxiety disorders, and a current treatment paradigm that falls short of delivering necessary relief, a new fast-acting treatment alternative is imperative. Initiation of our PALISADE-1 trial further reflects our commitment to go beyond the current standard of care for SAD. If successfully developed, PH94B has the potential to be the first fast-acting, non-systemic, non-sedating acute treatment of anxiety for more than 23 million Americans who suffer from SAD.”
Read the VistaGen Therapeutics press release.
