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VistaGen Expands PH94B Clinical Development to Include Adjustment Disorder Related to COVID-19
Proposed Phase 2 Study to Take Place in New York City Under U.S. FDA's Coronavirus Treatment Acceleration Program (CTAP) SOUTH SAN FRANCISCO, Calif., April
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"Proposed Phase 2 Study to Take Place in New York City Under U.S. FDA's Coronavirus Treatment Acceleration Program (CTAP)\n\n\nSOUTH SAN FRANCISCO, Calif., April 28, 2020 /PRNewswire/ -- VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) diseases and disorders with high unmet medical need, today announced plans to expand clinical development of PH94B, its first-in-class rapid-onset neuroactive nasal spray, to include treatment of adjustment disorder due to stressors related to the COVID-19 pandemic. Adjustment disorder is an emotional or behavioral reaction considered excessive or out of proportion to a stressful event or major life change, occurring within three months of the stressor, and/or significantly impairing a person's social, occupational and/or other important areas of functioning. \n\n \n \n \n \n \n \n\n \nVistaGen plans to submit its proposed protocol for a Phase 2 study of PH94B for treatment of adjustment disorder to the U.S. Food and Drug Administration (FDA) through the FDA's new Coronavirus Treatment Acceleration Program (CTAP). The proposed Phase 2 Part A study will be conducted in New York City, the epicenter of the COVID-19 pandemic in the U.S., on an open-label basis and involve approximately 30 subjects suffering from adjustment disorder from stressors related to the pandemic. Based on the results of the Phase 2 Part A study, VistaGen plans to advance development to a Phase 2 Part B randomized, double-blind, placebo-controlled study of approximately 150 subjects. The FDA previously designated PH94B for Fast Track development for treatment of social anxiety disorder (SAD), the first such designation by the FDA for a drug candidate for SAD. VistaGen is currently preparing for Phase 3 development of PH94B for treatment of SAD. \nDr. Michael Liebowitz, a member of VistaGen's CNS Clinical and Regulatory Advisory Board, will serve as Principal Investigator of the Phase 2 Part A study of PH94B for treatment of adjustment disorder. Dr. Liebowitz is a Professor of Clinical Psychiatry at Columbia University and directs the Medical Research Network LLC in New York City. He directed the Anxiety Disorders Clinic at the New York State Psychiatric Institute from 1982 to 2006 and is also creator...