Fasedienol Nasal Spray Reduces Anxiety Symptoms in Patients With SAD

Topline results were announced from a phase 3 study evaluating fasedienol (PH94B) nasal spray in adults diagnosed with social anxiety disorder (SAD).

Fasedienol is a first-in-class, rapid-onset investigational pherine nasal spray. The double-blind, placebo-controlled PALISADE-2 trial (ClinicalTrials.gov Identifier: NCT05011396) included 141 participants who were randomly assigned to receive fasedienol (n=70) or placebo (n=71) intranasally 20 minutes before a public speaking stressor. Patients had marked social anxiety at enrollment, with a baseline score on the Liebowitz Social Anxiety Scale (LSAS) of at least 70. The primary endpoint of the study was the difference in patient-reported Subjective Units of Distress Scale (SUDS) score during the public speaking challenge.

Findings showed that treatment with fasedienol resulted in a statistically significant difference in average SUDS score during a public speaking challenge compared with placebo (difference between groups of -5.8; P =.015). The trial also met its secondary endpoint with 37.7% of fasedienol-treated patients rated as responders (as measured by the Clinical Global Impression-Improvement scale) vs 21.4% of those who received placebo (P =.033). The treatment was reported to have a favorable safety profile consistent with prior trials.

“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 Dr Michael R. Liebowitz, innovator of the LSAS, 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 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.”

According to Vistagen, the PALISADE-2 trial has been stopped due to business reasons. Additional analysis of the data is ongoing and will be presented at a future medical meeting.

This article originally appeared on MPR