Vistagen Starts Phase 3 Study of Fasedienol for Social Anxiety Disorder Treatment

Vistagen, a biopharmaceutical company specializing in neuroscience and registered on Nasdaq as VTGN, has announced the enrollment of the first participant in its PALISADE-4 Phase 3 trial. This trial evaluates fasedienol, an innovative nasal spray designed to treat social anxiety disorder (SAD) acutely. Social anxiety disorder affects over 30 million individuals in the U.S. and is characterized by severe anxiety in social settings.

Shawn Singh, Vistagen's CEO, highlighted that the initiation of PALISADE-4 marks a significant milestone in the company's Phase 3 program for fasedienol. Singh emphasized the potential of fasedienol to provide a transformative acute treatment for SAD, particularly noting the current lack of an acute treatment option approved by the U.S. Food and Drug Administration (FDA). Fasedienol represents a pioneering approach to treating SAD by targeting the neural circuits involved in fear and anxiety through the nose-to-brain pathway, aiming for rapid, non-systemic relief.

The PALISADE Phase 3 program includes ongoing PALISADE-3 and PALISADE-4 trials, which are randomized, double-blind, placebo-controlled studies. Each trial is designed to assess the effectiveness, safety, and tolerability of fasedienol for relieving anxiety symptoms in SAD patients during public speaking challenges in a clinical setting. Both trials mirror the successful PALISADE-2 Phase 3 trial, from which Vistagen reported positive data the previous year. The primary measurement in these trials is the Subjective Units of Distress Scale (SUDS), a self-rated scale used by participants.

PALISADE-4, similar to PALISADE-3, will involve approximately 236 adult participants aged 18 to 65, randomly assigned to receive either fasedienol or a placebo in a 1:1 ratio. Additionally, both trials include open-label extension phases to evaluate the safety of long-term use of fasedienol over up to 12 months. Successful results from either PALISADE-3 or PALISADE-4, in conjunction with PALISADE-2, could provide substantial evidence to support a New Drug Application (NDA) submission to the FDA for fasedienol as an acute treatment for SAD.

Fasedienol is distinctive as a neuroactive pherine nasal spray with a novel mechanism of action, differentiating it from all current anxiety medications. It aims to modulate the olfactory-amygdala neural pathways of fear and anxiety without systemic absorption or direct neuronal interaction in the brain. Notably, fasedienol has shown no signs of abuse potential or dependency in trials to date. The U.S. FDA has also granted Fast Track designation to fasedienol for the acute treatment of SAD, recognizing its potential to address an unmet medical need.

Social anxiety disorder significantly impacts individuals' daily lives, causing intense fear and anxiety in various social situations that can hinder everyday activities, work, and social interactions. Despite its prevalence, there is no FDA-approved acute treatment for SAD, highlighting the need for innovative therapeutic options like fasedienol.

Vistagen operates from South San Francisco, CA, and focuses on developing groundbreaking therapies for psychiatric and neurological conditions. Their pipeline includes pherine product candidates administered as nasal sprays, aiming for rapid and targeted action through the nose-to-brain pathway. Vistagen is committed to advancing treatments that set new standards of care for individuals with anxiety, depression, and other neurological disorders.