VistaGen Therapeutics (NASDAQ: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (“CNS”) disorders, is reporting positive feedback from the U.S. Food and Drug Administration (“FDA”). The feedback is in relation to the company’s use of the Liebowitz Social Anxiety Scale (“LSAS”) as the primary endpoint for future clinical studies designed to evaluate the efficacy of a treatment for the overall control of symptoms of social anxiety disorder (“SAD”). According to the announcement, Vistagen is planning to use the LSAS for a phase 3 clinical study designed to evaluate fasedienol (PH94B) as a treatment for SAD. The FDA’s feedback confirms the acceptable use of the LSAS as a primary efficacy endpoint during the study, and the company is working to finalize components of its potential New Drug Application (NDA)-enabling development program for fasedienol for treatment of SAD. “With positive feedback from the FDA, we’re focused on advancing a clinical study design with the Liebowitz Social Anxiety Scale as the primary endpoint to study the real-world effects of fasedienol over time,” said Vistagen CEO Shawn Singh in the press release. “This is an important step forward, especially as SAD is becoming even more prevalent in a post-COVID world. With today’s announcement, we believe Vistagen has a clear path for the continued development of fasedienol and we are more committed than ever in our mission to create safe medicines that can improve mental health.”
To view the full press release, visit https://ibn.fm/JiFcZ
About VistaGen Therapeutics Inc.
Vistagen is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. The company is advancing therapeutics with the potential to be faster acting, and with fewer side effects and safety concerns than those that are currently available for treatment of anxiety and depression. Vistagen product candidates belong to a new class of drugs known as pherines, which are designed with a novel rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can beneficially impact key neural circuits without systemic uptake or direct activity on CNS neurons in the brain. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety and depression. For more information about the company, please visit www.VistaGen.com.
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