(RTTNews) - VistaGen Therapeutics (VTGN) said that it 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.
VistaGen 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 through the FDA's new Coronavirus Treatment Acceleration Program.
The company said it will conduct the proposed Phase 2 Part A study 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.
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.