Vistagen Therapeutics has announced the enrollment of the first participant in a Phase 2 repeat dose study of fasedienol, an investigational neuroactive pherine nasal spray, currently in Phase 3 development for the acute treatment of social anxiety disorder (SAD). The trial is designed to evaluate the efficacy, safety, and tolerability of a repeat dose of fasedienol in adults experiencing SAD.
The Phase 2 study is a U.S.-based, multi-center, randomized, double-blind, placebo-controlled, three-arm clinical trial. Participants will undergo a public speaking challenge in a clinical setting to assess the drug's effects. The three arms of the study involve different dosing regimens: fasedienol followed by fasedienol (total 6.4 micrograms), fasedienol followed by placebo (total 3.2 micrograms), and placebo followed by placebo. The second dose in each arm is administered ten minutes after the initial dose.
According to Shawn Singh, President and Chief Executive Officer of Vistagen, this trial marks a significant milestone in the company's Phase 3 program for SAD. He noted the increasing prevalence of SAD and the lack of FDA-approved acute treatment options, emphasizing the company's mission to address this unmet need through the PALISADE Phase 3 program for fasedienol.
PALISADE Phase 3 Program
Vistagen's U.S. registration-directed PALISADE Phase 3 program includes the statistically significant PALISADE-2 trial, along with the ongoing PALISADE-3 and PALISADE-4 trials, and this Phase 2 repeat dose study. PALISADE-3 and PALISADE-4 mirror the design of PALISADE-2, evaluating the acute administration of fasedienol to alleviate anxiety symptoms induced by a public speaking challenge. Vistagen believes that positive results from either PALISADE-3 or PALISADE-4, combined with PALISADE-2, could provide sufficient evidence for a New Drug Application (NDA) submission to the FDA for the acute treatment of SAD.
About Fasedienol
Fasedienol is a potential first-in-class, investigational neurocircuitry-focused pherine nasal spray engineered for rapid onset. Its mechanism of action (MOA) differs from currently approved anxiety medications. Fasedienol is designed to regulate the olfactory-amygdala neural circuits associated with fear and anxiety and to attenuate the sympathetic autonomic nervous system without systemic absorption, potentiation of GABA-A receptors, or direct binding to brain neurons. The FDA has granted Fast Track designation for the development of fasedienol for the acute treatment of SAD, highlighting the urgent need for new treatment options.
