Vistagen has announced that the last patient completed the final visit in the randomized, double-blind, placebo-controlled portion of PALISADE-4, the company’s Phase 3 clinical trial evaluating fasedienol nasal spray for acute treatment of social anxiety disorder. Topline results for the randomized portion are expected in the second quarter. The open-label extension portion of the study remains ongoing, with participants able to use fasedienol in their daily lives up to six times per day for up to twelve months.
Trial Design and Analysis
PALISADE-4 is a U.S. multi-center study designed to evaluate the efficacy, safety, and tolerability of a single dose of fasedienol in reducing anxiety symptoms in adults with social anxiety disorder during a simulated anxiety-provoking public speaking challenge, using the Subjective Units of Distress Scale as the primary endpoint. Based on analyses of datasets from the PALISADE-1, PALISADE-2, and PALISADE-3 Phase 3 studies, Vistagen refined the statistical analysis plan for PALISADE-4 to incorporate each participant’s distress level immediately prior to dosing as measured by baseline SUDS into the primary efficacy analysis. The FDA has informed the company it has no comments on these refinements, and no changes were made to the clinical study protocol as a result of the ongoing analyses.
Social Anxiety Disorder Context
Social anxiety disorder is a highly prevalent, serious psychiatric condition affecting over 30 million adults in the U.S., sometimes manifesting acutely when triggered by anxiety-provoking social and performance situations in daily life. The condition can significantly disrupt social life and hinder occupational functioning, and it increases the risk of depression and substance use disorders, suicidal ideation, and suicide. Fasedienol’s proposed mechanism is fundamentally differentiated from FDA-approved anti-anxiety medications. When administered intranasally in microgram-level doses, fasedienol modulates nasal-limbic amygdala fear and anxiety neurocircuits involved in social anxiety disorder pathophysiology, and achieves its rapid-onset anxiolytic effects without apparent systemic absorption or uptake into the brain. The FDA has granted fasedienol Fast Track designation for acute treatment of social anxiety disorder.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/vistagen-announces-completion-of-last-patient-visit-in-palisade-4-phase-3-public-speaking-challenge-study-of-fasedienol-for-acute-treatment-of-social-anxiety-disorder