Adjustment Disorder

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. Adjustment disorder with anxiety (AjDA) is an emotional or behavioral reaction considered excessive or disproportionate to a sudden change, stressful event or major life change, such as loss of work, divorce or health setback, occurring within three months of the stressor, and/or significantly impairing a person’s social, occupational and/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.

The mental health stressors associated with the COVID-19 pandemic have directly or indirectly affected hundreds of millions of individuals around the world and have considerably increased the prevalence of AjDA. We believe the mental health impact of the COVID-19 pandemic will be long-term and varied across a wide range of anxiety disorders.

VistaGen’s Innovation:

PH94B has potential as a novel, treatment of anxiety for adults with AjDA, including stress and impaired functioning as a result of recent-onset of stressors brought on by the health, safety, economic and social circumstances, including, but not limited to, circumstances related to and consequences of the COVID-19 pandemic and civil unrest in 2020.

Development Status:

In addition to our PALISADE Phase 3 Program for PH94B in Social Anxiety Disorder, our Exploratory Phase 2A Program for PH94B is aimed at multiple anxiety disorders with unmet needs, the first of which is Adjustment Disorder with Anxiety (AjDA). In October 2021, VistaGen initiated a Phase 2A study of PH94B for treatment of anxiety in adults with AjDA. We are also preparing to explore PH94B’s potential in postpartum anxiety, post-traumatic stress disorder (PTSD), and procedural anxiety through a series of small Phase 2A clinical trials. With an alarming increase in the prevalence of anxiety-related disorders since the onset of the COVID 19 pandemic in early 2020, we remain committed to becoming part of the solution for people who need to find help.