PH94B for Social Anxiety Disorder (SAD)

An estimated 12.1% of U.S. adults experience social anxiety disorder (SAD) at some time in their lives.1 “The essential feature of social anxiety disorder is a marked and persistent fear of social or performance situations in which an individual believes embarrassment could occur as a consequence of exposure to unfamiliar people or possible scrutiny by others.”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 

There are no medications approved for as-needed use for feared situations for individuals with SAD. While several selective serotonin reuptake inhibitors (SSRIs) and selective serotonin-norepinephrine reuptake inhibitors (SNRIs) are FDA-approved for treatment of SAD, they take weeks to months to work, are of limited help to affected individuals and often present troubling side effects. Individuals affected by SAD need treatments with fast onset benefits and fewer side effects.

We are preparing to advance intranasal PH94B into pivotal Phase 3 development in 2019 for the rapid-onset, on demand 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 intranasal PH94B 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 existing therapeutic options.

  2. Liebowitz MR, Hanover R, Draine A, Lemming R, Careri J, Monti L (2016). Effect of as‐needed use of intranasal PH94B on social and performance anxiety in individuals with social anxiety disorder. Depress Anxiety 33: 1081-1089.
  3. American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.