Vistagen (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, today announced positive data from its phase 3 open-label study. According to the update, the study is designed to evaluate the safety and tolerability of multiple, as-needed intranasal administrations of fasedienol (“PH94B”) over time in adults with social anxiety disorder (“SAD”). “The safety profile and potential for fasedienol to achieve overall reduction in symptoms of SAD and improvement in severity of the disorder, as measured by the LSAS, have now been demonstrated in a placebo-controlled phase 2 study after two weeks of use, as well as in this open-label study over a period of one month and beyond,” said Vistagen CEO Shawn Singh. “We believe these data suggest that studies involving multiple administrations of fasedienol over time, on an as-needed basis at moments when subjects experience real-life, socially stressful situations, most accurately demonstrate the safety and efficacy potential of fasedienol in patients with SAD and reflect the way we believe fasedienol would be used by SAD patients, if approved. Each SAD patient is unique, and we believe an optimal SAD treatment is one that is individualized and tailored-to-fit by patients, as-needed, to help them engage in the anxiety-provoking situations they encounter in their daily lives with less fear and anxiety.”
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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 disorders. Several of Vistagen’s 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, visit the company’s website at www.Vistagen.com.
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