VistaGen to Present PH94B Exploratory Phase 2A Research Program for Adjustment Disorder with Anxiety at American Society for Clinical Psychopharmacology Annual Meeting
The clinical trial abstract for the Company’s ongoing exploratory Phase 2A clinical trial, entitled “Efficacy, safety, and tolerability of PH94B in adjustment disorder with anxiety: design of an exploratory phase 2A clinical trial,” describes the clinical trial protocol intended to evaluate PH94B’s potential to treat adults living with AjDA, a disorder with potential for increased prevalence during these uncertain times. PH94B is a first-in-class, odorless, tasteless rapid-onset (approximately 15 minutes) investigational pherine nasal spray with a novel mechanism of action (MOA) that regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic autonomic nervous system. VistaGen is also currently evaluating PH94B in the Company’s two PALISADE Phase 3 clinical trials for the acute treatment of anxiety in adults with social anxiety disorder (SAD).
“Mental health challenges are accelerating in communities across America. Patients and healthcare providers are seeking better solutions to the growing prevalence of anxiety and depression, and VistaGen is working hard to develop innovative solutions,” said
The ASCP Annual Meeting is the premiere meeting each year in the field of psychopharmacology and brings together over 800 academic and industry investigators, research pharmacists, and clinicians, the
VistaGen’s PH94B is a first-in-class, odorless, tasteless rapid-onset (approximately 15 minutes) investigational pherine nasal spray with a novel mechanism of action (MOA) that regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic autonomic nervous system. Based on positive Phase 2 data in social anxiety disorder (SAD) patients, VistaGen is currently evaluating PH94B in two Phase 3 clinical studies in the
About Adjustment Disorder with Anxiety
Almost everyone experiences significant life events, changes, or stressors from time to time, and while some individuals adjust to such changes within a few months, others cannot and may experience adjustment disorder. Adjustment disorder with anxiety (AjDA) is the development of emotional or behavioral symptoms considered excessive or disproportionate in response to a sudden change, stressful event or circumstance, or other identifiable anxiety-provoking stressor, such as loss of work, divorce or a health setback, that significantly impairs a person’s social, occupational and/or other important area(s) of functioning.
VistaGen (Nasdaq: VTGN) is a late clinical-stage, CNS-focused biopharmaceutical company striving to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. The Company is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns, than those that are currently available. VistaGen’s clinical-stage candidates are targeting multiple forms of anxiety and depression. They belong to a new class of drugs known as pherines, which are odorless, neuroactive steroids that bind to distinct receptors on chemosensory neurons in the nasal passages and can impact the limbic amygdala without systemic uptake or direct activity on CNS neurons in the brain. VistaGen’s lead candidate, PH94B, is a nasally administered spray currently in multiple Phase 3 trials in the
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