Vistagen has announced the initiation of a Phase 2 repeat dose study of fasedienol nasal spray, which the company is developing for the treatment of social anxiety disorder. The Phase 3 PALISADE-3 and PALISADE-4 trials of fasendiol for that indication are ongoing.
According to Vistagen, the design of the Phase 2 repeat dose trial is basically the same as the design of the PALISADE trials, including a public speaking challenge, except for the inclusion of a repeat dose arm. Subjects in the new study will receive either a 3.2 mcg dose of fasendiol followed by a second 3.2 mcg dose 10 minutes later; a dose of fasendiol followed by placebo; or placebo followed by placebo.
Vistagen President and CEO Shawn Singh commented, “The initiation of this fasedienol repeat dose study marks another significant milestone in our US Phase 3 program for the acute treatment of social anxiety disorder. With the increasing prevalence of social anxiety disorder over decades, millions of individuals in the US live with debilitating acute fear and anxiety in everyday social situations without any US FDA-approved acute treatment option. Our mission and PALISADE Phase 3 program for fasedienol are focused on changing that.”
Read the Vistagen press release
