Vistagen Launches Phase 3 Trial for Fasedienol in Social Anxiety Disorder

A significant clinical trial is currently underway as part of the PALISADE Phase 3 program, which is focused on the development of fasedienol for the treatment of social anxiety disorder (SAD). This disorder impacts over 25 million Americans and is characterized by intense anxiety or fear in social situations.

Vistagen Therapeutics, a biopharmaceutical company at the forefront of neuroscience, has announced the enrollment of the first participant in the PALISADE-3 trial. The study is designed to assess the efficacy, safety, and tolerability of fasedienol, an investigational pherine candidate, for acute treatment of SAD. The trial follows a randomized, double-blind, placebo-controlled format, similar to its predecessor, PALISADE-2. It aims to measure the relief of anxiety symptoms induced by a public speaking challenge in a clinical environment, with the Subjective Units of Distress Scale (SUDS) serving as the primary outcome measure. Approximately 236 adults aged 18 to 65 are expected to participate in this U.S.-based, multi-center study. Upon completion of PALISADE-3, participants will have the option to join an open-label extension. Vistagen also plans to initiate PALISADE-4, a replicate of PALISADE-3, in the latter half of 2024.

Fasedienol, the investigational pherine nasal spray developed by Vistagen, is a first-in-class treatment with a novel mechanism of action that differs from currently approved anxiety medications. It is designed to regulate the olfactory-amygdala neural circuits associated with fear and anxiety and to reduce the sympathetic autonomic nervous system's tone without systemic distribution or direct brain neuron activity. Notably, fasedienol has not shown any potential for abuse or physical dependence in clinical trials thus far. The U.S. FDA has recognized the significance of this treatment by granting it Fast Track designation for the acute treatment of SAD.

SAD is a pervasive condition that can severely hinder an individual's ability to work, attend school, and engage in social activities. Current treatments, which include antidepressants with slow onset and known side effects, do not offer an acute, as-needed solution for SAD sufferers.

Vistagen is dedicated to advancing its pherine pipeline, offering innovative neuroscience-based therapies for mental health disorders. The company's pipeline includes five clinical-stage candidates from the pherine class, which are neuroactive nasal sprays that target fundamental neural circuitry without the need for systemic absorption or brain receptor binding. Additionally, Vistagen is exploring an oral prodrug with the potential to modulate NMDA receptor activity. The company's mission is to provide differentiated treatments that set new standards of care for individuals living with anxiety, depression, and neurological disorders.