Vistagen Advances Toward New Social Anxiety Treatment with Phase 3 PALISADE-4 Trial of Fasedienol

Vistagen (Nasdaq: VTGN), a biopharmaceutical company focused on treatments for psychiatric and neurological disorders, has begun enrollment in its PALISADE-4 Phase 3 trial. This trial is part of Vistagen’s ongoing efforts to evaluate fasedienol, an investigational nasal spray, for the acute treatment of Social Anxiety Disorder (SAD). SAD affects more than 30 million Americans, and there are currently no FDA-approved acute treatments available.

Key Highlights:

  • Trial Start: PALISADE-4 is the second Phase 3 study in Vistagen’s registration-directed program for fasedienol.
  • Treatment Goal: Fasedienol is designed to treat acute symptoms of Social Anxiety Disorder by rapidly activating neural circuits in the brain, with minimal systemic absorption.
  • Participant Enrollment: The trial aims to enroll approximately 236 adults between the ages of 18 and 65.
  • Primary Outcome: The study will measure anxiety reduction during social challenges using the Subjective Units of Distress Scale (SUDS).
  • Regulatory Path: Success in this trial, alongside the ongoing PALISADE-3 study, could lead to a New Drug Application (NDA) submission to the FDA.

Shawn Singh, CEO of Vistagen, added, “With the initiation of PALISADE-4 as planned, we have achieved another important milestone in our registration-directed PALISADE Phase 3 program for fasedienol, which has the potential to deliver a transformative acute treatment option to over 30 million Americans suffering from the debilitating effects of SAD, including increased risk for depression, alcohol abuse, and suicide attempts.”

 

About Vistagen

Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a late clinical-stage neuroscience-focused biopharmaceutical company dedicated to the development and commercialization of groundbreaking therapies for psychiatric and neurological disorders based on its pioneering approach and deep understanding of nose-to-brain neurocircuitry. Vistagen’s diversified pipeline of pherine product candidates is designed exclusively as nasal sprays administered at microgram level doses to rapidly activate chemosensory neurons in the nasal cavity with novel non-systemic proposed mechanisms of action designed to impact the olfactory system and brain neurocircuitry to achieve diverse therapeutic effects. Favorable safety data have been generated in all clinical studies of Vistagen’s pherine product candidates completed to date. Vistagen’s neuroscience pipeline also includes an oral prodrug with the potential to modulate NMDA receptor activity in certain neurological conditions, such as levodopa-induced dyskinesia associated with Parkinson’s disease therapy and neuropathic pain.

 

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Vistagen Advances Toward New Social Anxiety Treatment with Phase 3 PALISADE-4 Trial of Fasedienol

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