Social Anxiety Disorder
Social anxiety disorder (SAD) affects as many as 25 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 in the nasal passages and can impact the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic autonomic nervous system 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.
Taking into consideration the results of PALISADE-1, and as we await the results of an independent third-party biostatistician’s interim analysis of PALISADE-2, we remain steadfast in our commitment to changing the trajectory of mental health care and in the potential of our drug candidates to achieve our mission. As to PH94B in SAD, we believe the combination of the overall safety profile of PH94B in studies to date, data from the two Phase 2 clinical studies of PH94B in SAD, and emerging preliminary multiple administration assessment data from our PALISADE Open Label Safety(OLS) study indicate a potential for SAD patients to achieve cumulative functional improvement with longer uses of PH94B, while still use acutely, as-needed. After the results of the interim analysis are available to us, we plan to meet with the FDA and pursue consensus on a clearly defined path forward for further Phase 3 development of PH94B in SAD.
1. Sources: Kantar Health. Nov 2021. National Health and Wellness Survey (NHWS), 2021. [US]. Malvern, PA.
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.