Social Anxiety Disorder
Social anxiety disorder (SAD) affects as many as 23.7 million Americans and is the second most commonly diagnosed anxiety disorder.1,2 A person with SAD feels intense, persistent symptoms of anxiety or fear in certain social situations, such as meeting new people, dating, being on a job interview, answering a question in class, or talking to a cashier in a store. Doing common, everyday things in front of people causes profound anxiety or fear of being humiliated, evaluated, judged, or rejected. SAD can get in the way of going to work, attending school, or doing a wide variety of activities that occur in a situation that has the potential for interpersonal interaction. It can lead to avoidance and opportunity cost that can significantly impact a person's employment and social activities and be very disruptive to overall quality of life and can predispose individuals to other anxiety disorders, depression and substance use disorders.3
SAD usually starts during youth. Without treatment, social anxiety disorder can last for many years or a lifetime and prevent a person from reaching his or her full potential.
There is no U.S. Food and Drug Administration (FDA)-approved medication for acute (as-needed) treatment of anxiety in individuals with SAD. SAD is commonly treated chronically with certain FDA-approved antidepressants, which have a slow onset of effect (several weeks) and limited therapeutic benefits, and benzodiazepines, which are not FDA-approved for the treatment of SAD but are prescribed for off-label use. Both antidepressants and benzodiazepines have known side effects and safety concerns that may make them unattractive to individuals affected by SAD. Individuals affected by SAD need novel treatment alternatives with fast onset therapeutic benefits and far fewer side effects.
PH94B nasal spray is fundamentally different from all current drug treatments for SAD. PH94B activates nasal chemosensory neurons that trigger neural circuits in the brain that suppress fear and anxiety. With its novel mechanism of pharmacological action, rapid-onset of therapeutic effects and favorable safety and tolerability profile shown in all clinical trials to date, PH94B has the potential to become the first FDA-approved acute treatment for SAD.
VistaGen’s PALISADE Phase 3 Program is designed to further demonstrate the potential of PH94B as a fast-acting, acute treatment of anxiety in adults with SAD. Upon completion of the PALISADE Phase 3 Program, if successful, VistaGen plans to submit a New Drug Application (NDA) to the FDA for PH94B for the acute treatment of anxiety in adults with SAD in 2023. PALISADE-1 and PALISADE-2 are replicate U.S., multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trials designed to evaluate the efficacy, safety, and tolerability of PH94B for the acute treatment of anxiety in adults with SAD. Topline results for PALISADE-1 and PALISADE-2 are anticipated in 2022. The Company is also conducting additional NDA enabling studies for PH94B.
1. Kantar National Health and Wellness Survey (NHWS), 2020
2. Anxiety and Depression Association of America
3. American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.