PH94B for Adjustment Disorder
Almost everyone experiences significant life events, changes, or stressors and while some individuals adjust to such changes within a few months, others cannot and may struggle with adjustment disorder. According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) published by the American Psychiatric Association, adjustment disorder is the development of emotional or behavioral symptoms in response to an identifiable stressor(s) occurring within 3 months of the onset of the stressor(s). These symptoms or behaviors are clinically significant, as evidenced by one or both of the following: marked distress that is out of proportion to the severity or intensity of the stressor, considering the external context and the cultural factors that might influence symptom severity and presentation; or significant impairment in social, occupational, or other important areas of functioning. The stress-related disturbance does not represent normal bereavement or meet the criteria for another mental disorder and is not merely an exacerbation of a preexisting mental disorder.
VistaGen’s PH94B, a first-in-class, odorless, rapid-onset (approximately 10 to 15 minutes) CNS neuroactive nasal spray, may have potential to treat adjustment disorder. VistaGen has submitted 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 on an open-label basis and involve approximately 30 subjects suffering from adjustment disorder from stressors related to the current coronavirus 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.