Vistagen has announced the initiation of the Phase 3 PALISADE-3 public speaking trial of fasedienol (PH94B) nasal spray in people with social anxiety disorder. In August 2023, the company announced that the Phase 3 PALISADE-2 trial had met its primary endpoint although that study was closed early and enrolled only about 2/3 of the expected number of subjects. The PALISADE-2 trial was stopped after the PALISADE-1 trial failed to meet its primary endpoint.
According to Vistagen, the PALISADE-3 trial is similar to PALISADE-2 and is expected to enroll 236 adults up to age 65 who will receive either fasendienol or placebo prior to a public speaking challenge. The company said that it expects to initiated the PALISADE-4 trial, which has the same design as PALISADE-3, later this year.
Vistagen CEO Shawn Singh commented, “Initiating PALISADE-3 is another major milestone in our plan to develop and commercialize fasedienol as the first treatment of its kind for social anxiety disorder. We look forward to initiating PALISADE-4 in the second half of this year and advancing our innovative pherine pipeline to deliver pioneering neuroscience to patients affected by mental health disorders and unsatisfied with current treatments.”
PH94B was initially developed for the treatment of social anxiety disorder by Pherin Pharmaceuticals, and Vistagen acquired the rights to the nasal spray for that indication in 2018. In December 2022, Vistagen announced its acquisition of Pherin.
Read the Vistagen press release.
