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NetworkNewsBreaks – VistaGen Therapeutics Inc. (NASDAQ: VTGN) Preparing Phase 3 Trial to Evaluate Neuroactive Nasal Spray Treatment for SAD

VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company developing new-generation medicines with the potential to go beyond the current standard of care for anxiety, depression and other central nervous system (“CNS”) disorders, has announced plans to begin a Phase 3 clinical trial in Q2 2021. The clinical trial will evaluate PH94B (“PH94B”), a neuroactive nasal spray designed to provide rapid onset of action for the acute treatment of anxiety in adults with social anxiety disorder (“SAD”). With an estimated 20 million people in the United States suffering from SAD, it is one of the most prevalent mental health conditions in the country. VistaGen also has second neuroactive nasal spray in development; PH10 (“PH10”) is designed for potential rapid onset treatment of major depressive disorder (“MDD”) and other depressive disorder. Currently no FDA-approved, fast-acting, as-needed treatment for SAD exists. FDA-approved antidepressants and off-label use of benzodiazepines are often prescribed for the disorder, and they have potential for significant side effects. “We are committed to developing and commercializing new-generation medicines that go beyond the current standard of care for anxiety, depression and other CNS disorders,” said VistaGen CEO Shawn Singh in a recent article. “The COVID-19 pandemic is causing a mental health crisis the likes of which we have never seen before, with alarming increases in anxiety, stress, depression and suicide. . . . Stress-provoking episodes are soaring, especially as routines are being disrupted, and we’ve seen skyrocketing prescriptions of benzodiazepines, which carry with them the potential for misuse, abuse and addiction, even when taken at recommended dosages.”

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