In the first positive phase 3 study of an investigational therapy for social anxiety disorder (SAD) in over 15 years, results from the 3 PALISADE-2 trial demonstrated the efficacy, safety, and tolerability of fasedienol (PH94B) in adults diagnosed with SAD. Fasedienol—a first-in-class, rapid-onset pherine nasal spray—has a novel proposed mechanism of action that regulates the olfactory-amygdala neural circuits of fear and anxiety.
“We are thrilled that these compelling top-line results from the phase 3 PALISADE-2 trial confirm what was seen in the phase 2 studies in social anxiety disorder and highlight the potential for fasedienol, with its novel and unique proposed mechanism of action, to transform what is possible for more than 25 million people living with social anxiety in the US and millions more affected worldwide,” stated Shawn Singh, Chief Executive Officer of Vistagen.
Investigators enrolled 141 participants with diagnosis of SAD and marked social anxiety in the multi-center, randomized, double-blind, placebo-controlled study. They examined the effect of acute administration of fasedienol on anxiety symptoms during a public speaking simulation, as measured using the patient-reported Subjective Units of Distress Scale (SUDS( score. Participants had, as evidenced by a baseline score on the Liebowitz Social Anxiety Scale (LSAS) of at least 70 at enrollment.
PALISADE-2 met its primary endpoint, as fasedienol demonstrated a statistically significant difference in average SUDS score during the public speaking challenge as compared with placebo (p=0.015). The trial also met its secondary endpoint by demonstrating a statistically significant difference in the proportion of clinician-assessed responders between fasedienol and placebo as measured by the CGI-I scale (p=0.033).
“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,” said Michael R. Liebowitz, creator of the LSAS, director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute, and current Managing Director of The Medical Research Network LLC in New York City. “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.”
1. Vistagen announces positive top-line results from phase 3 PALISADE-2 trial of fasedienol (PH94B) nasal spray in social anxiety disorder. Vistagen. News release. August 7, 2023. Accessed August 8, 2023. https://www.vistagen.com/news-releases/news-release-details/vistagen-announces-positive-top-line-results-phase-3-palisade-2