VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company committed to developing a new generation of medicines with the potential to go beyond the current standard of care for anxiety, depression and other central nervous system (“CNS”) disorders, is beginning its PALISADE-1 phase 3 trial. The randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of VTGN’s PH94B (“PH94B”) for the treatment of anxiety in adults with Social Anxiety Disorder (“SAD”). In the announcement, the company noted there is no FDA-approved acute treatment for the disorder. The company plans to include some 200 randomized subjects in the study, which will be held at an estimated 18 sites across the country with Dr. Michael Liebowitz as principal investigator. Liebowitz is a Columbia University psychiatrist and is the former director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute; he currently serves as director of the Medical Research Network in New York City and creator of the Liebowitz Social Anxiety Scale (“LSAS”). VistaGen anticipates topline results from the trial to be available mid-year in 2022. VGTN’s proprietary PH94B is an odorless, rapid-onset, investigational pherine nasal spray. “Initiation of PALISADE-1 is a major milestone for our PALISADE Phase 3 clinical program for PH94B, a program aimed at supporting a potential New Drug Application to the FDA,” said VistaGen CEO Shawn Singh in the press release. “The trial is an essential next step in our efforts to confirm the positive efficacy and safety results we have seen in all PH94B Phase 2 trials to date. PH94B has the potential to be a life-changing acute, as-needed treatment of anxiety for adults with SAD, similar to how a rescue inhaler is used to prevent an asthma attack. At a time of continuing increase in the number of Americans suffering from SAD and other anxiety disorders, and a current treatment paradigm that falls short of delivering necessary relief, a new fast-acting treatment alternative is imperative.”
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About VistaGen Therapeutics Inc.VistaGen is a biopharmaceutical company committed to developing and commercializing innovative medicines with the potential to go beyond the current standard of care for anxiety, depression and other CNS disorders. Each of VistaGen’s drug candidates has a differentiated potential mechanism of action, has been well tolerated in all clinical studies to date and has therapeutic potential in multiple CNS markets. For more information about the company, please visit www.VistaGen.com.
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