Social Anxiety Disorder (SAD)

An estimated 12.1% of U.S. adults experience Social Anxiety Disorder (SAD) at some time in their lives.1 SAD is characterized by excessive anxiety about scrutiny or evaluation by others that leads an individual to avoid social situations and/or performance.2 SAD affects social, academic and work life and often presents with other anxiety disorders, major depressive disorder, and substance use disorders, and the onset of SAD generally precedes that of the other disorders.3 Currently, selective serotonin reuptake inhibitors (SSRIs) and selective serotonin-norepinephrine reuptake inhibitors (SNRIs) are FDA-approved for treatment of SAD, but they take weeks to months to work, must be taken chronically and present numerous side effects. Individuals affected by SAD need treatments with faster onset, more consistent efficacy, and fewer side effects.

PH94B is currently in late-stage clinical development for the acute treatment of SAD symptoms. Early studies provided impressive evidence of rapid (10-15 minutes) anxiety reduction for subjects with SAD. In all prior clinical studies, PH94B was well tolerated and there were no adverse events associated with the nasal spray administration. Clinical results position PH94B nasal spray to potentially be a superior treatment alternative for SAD due to the demonstrated rapid onset of efficacy, route of administration, as-needed dosing convenience and excellent safety profile compared to other existing therapeutic options which often take any weeks to work, require chronic dosing and have concurrent side effects.

1 https://www.nimh.nih.gov/health/statistics/social-anxiety-disorder.shtml
2 https://adaa.org/understanding-anxiety/social-anxiety-disorder
3 American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.