Vistagen has announced the initiation of the Phase 3 PALISADE-4 trial of fasedienol pherine nasal spray in people with social anxiety disorder (SAD). According to the company, the PALISADE-4 trial is similar to the PALISADE-3 trial, which was initiated earlier this year. Both of those studies have protocols that are similar to the PALISADE-2 trial, which the company said met its primary endpoint despite being closed early. An earlier study, PALISADE-1, failed to meet its primary endpoint.
All of the Phase 3 trials include a public speaking challenge and use the self-assessed Subjective Units of Distress Scale (SUDS) as the primary endpoint. The company said that it believes that it could support an NDA for the intranasal therapy based on data from PALISADE-2, which enrolled only about 2/3 of the subjects that had been anticipated, and either PALISADE-3 or PALISADE-4, if one of those succeeds.
Vistagen CEO Shawn Singh commented, “With the initiation of PALISADE-4 as planned, we have achieved another important milestone in our registration-directed PALISADE Phase 3 program for fasedienol, which has potential to deliver a transformative acute treatment option to over 30 million Americans suffering from the debilitating effects of SAD, including increased risk for depression, alcohol abuse, and suicide attempts. Current pharmacological therapies approved by the US FDA do not include an acute treatment option. With pioneering neuroscience, we are breaking new ground in the development of a treatment for SAD with our novel product candidate designed for non-systemic, rapid activation of nose-to-brain neural circuits to reduce fear and anxiety associated with SAD.”
Read the Vistagen press release.
