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 neuroactive nasal spray may have potential to treat adjustment disorder. VistaGen has submitted its proposed protocol for an exploratory Phase 2A 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). We are currently in discussions with the FDA regarding the proposed study.  The proposed exploratory Phase 2A study will be conducted in New York City on an open-label basis and involve approximately 30 subjects suffering from adjustment disorder with anxiety. Based on the results of the Phase 2A study, VistaGen plans to advance development to a Phase 2B randomized, double-blind, placebo-controlled study of approximately 150 subjects.