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, has reported the results of its phase 3 open-label study of fasedienol (“PH94B”) nasal spray for the treatment of adults with social anxiety disorder (“SAD”). The company presented the results during at the 2023 annual meeting for the American Society for Clinical Psychopharmacology (“ASCP”), which was held earlier this week. The phase 3 study evaluated the long-term safety and tolerability of multiple, patient-tailored, as-needed administrations of fasedienol in adults dealing with SAD, specifically when they were experiencing social and performance stressors. According to the announcement, data gathered from nearly 500 patients in real-world settings indicate that patient-tailored, as-needed administrations of fasedienol over time were safe and well tolerated. During the presentation, the company reported that positive exploratory fasedienol efficacy data measured by the Liebowitz Social Anxiety Scale (“LSAS”) demonstrated clinically meaningful reductions in fear, anxiety and avoidance of anxiety-provoking social and performance situations in daily life; the results built on LSAS data gathered from a previous real-world, placebo-controlled phase 2 study. “These data advance the body of evidence supporting fasedienol’s safety profile and potential to achieve overall reduction in anxiety for adults suffering with social anxiety disorder, and we were excited to present these important findings to the ASCP community,” said Vistagen Therapeutics CEO Shawn Singh in the press release. “There are significant gaps in care for mental health patients, and many are seeking fast-acting medications with a favorable safety profile. When used as-needed and over time in their daily lives, as in this open-label study and a prior placebo-controlled phase 2 study, we believe fasedienol, with its exceptional safety profile, has the potential to help change the treatment landscape for social anxiety disorder.”
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About Vistagen Therapeutics Inc.
Vistagen Therapeutics 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, depression and CNS disorders. Vistagen’s pipeline includes six clinical-stage product candidates, including five investigational agents belonging to a new class of drugs known as pherines, in addition to AV-101, an oral antagonist of the glycine site of the N-methyl-D-aspartate receptor (“NMDAR”). Pherines, which are administered as nasal sprays, are designed with an innovative rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can selectively and beneficially impact key neural circuits in the brain without requiring systemic uptake or direct activity on CNS neurons. Vistagen’s AV-101 inhibits activity of the ion channel of the NMDAR but does not block it. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression and several other CNS disorders. For more information about the company, please visit www.Vistagen.com.
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