Vistagen (NASDAQ:VTGN) announced positive top-line results from its Phase 3 PALISADE-2 trial evaluating the efficacy, safety, and tolerability of fasedienol nasal spray in adults diagnosed with social anxiety disorder (SAD).
The trial met its primary endpoint, with fasedienol demonstrating a statistically significant difference in average SUDS score during a public speaking challenge, compared with placebo.
The trial also met its secondary endpoint, demonstrating a statistically significant difference in the proportion of clinician-assessed responders between fasedienol and placebo as measured by the CGI-I scale. Fasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials.
“As a new class of medicines, our pherine nasal spray pipeline holds the potential to transform the treatment landscape across numerous therapeutic areas,” Shawn Singh, CEO of Vistagen, said in a statement. “At the head of that class, fasedienol’s potential, as demonstrated in this Phase 3 trial, sets the stage for the first fundamentally new class of medicine for individuals living with SAD in more than 20 years.”
Dr. Michael Liebowitz said Fasedienol demonstrated a rapid and very clinically meaningful reduction in SUDS score, “indicating a single administration has the potential to reduce anxiety symptoms during an anxiety-provoking situation.”
Dr. Liebowitz is the innovator of the Liebowitz Social Anxiety Scale, former Columbia University psychiatrist, director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute, and current managing director of The Medical Research Network in New York City.
He said a future Phase 3 study involving multiple administrations of fasedienol over several weeks on a patient-tailored, as-needed basis will build on the body of evidence now demonstrated in PALISADE-2 and multiple Phase 2 studies.
“Fasedienol could be an optimal treatment for social anxiety patients given its ability to be used acutely to reduce anxiety while helping to reduce SAD severity over time,” he added.
