Effect of an Acute Intranasal Aerosol Dose of PH94B on Social and Performance Anxiety in Women With Social Anxiety Disorder

• Published in: The American journal of psychiatry Vol. 171; no. 6; pp. 675 - 682
• Main Authors: Liebowitz, Michael R., Salman, Ester, Nicolini, Humberto, Rosenthal, Norman, Hanover, Rita, Monti, Louis
• Format: Journal Article
• Language: English
• Published: United States American Psychiatric Association 01.06.2014
• Subjects: Administration, Intranasal; Adolescent; Adult; Aerosols; Aged; Androstenols - administration & dosage; Androstenols - therapeutic use; Anti-Anxiety Agents - administration & dosage; Anti-Anxiety Agents - therapeutic use; Anxiety; Clinical trials; Drug dosages; Female; Humans; Interpersonal Relations; Middle Aged; Phobic Disorders - drug therapy; Phobic Disorders - psychology; Psychiatric Status Rating Scales; Psychological Tests; Psychopharmacology; Social interaction; Treatment Outcome; Womens health; Young Adult
• ISSN: 0002-953X; 1535-7228
• DOI: 10.1176/appi.ajp.2014.12101342

PH94B, an investigational drug for the acute treatment of social anxiety disorder, was found to be rapidly and significantly effective at reducing highly disturbing performance anxiety symptoms in women who were pretreated with PH94B before public speaking, especially in reducing anticipation anxiety. ObjectiveAlthough social anxiety disorder is a common and sometimes disabling condition, there are no approved treatments that can be used on an as-needed basis. The authors examined the acute use of PH94B, an intranasally administered neurosteroidal aerosol, for the acute management of the symptoms of social anxiety disorder.MethodThe authors conducted a phase 2, multicenter, randomized, double-blind, placebo-controlled, single-dose study of PH94B. Ninety-one women 19–60 years of age with generalized social anxiety disorder received placebo intranasal spray (single-blind) 15 minutes before laboratory-simulated public speaking and social interaction challenges. Patients who experienced significant distress during at least one challenge returned 1 week later to receive either intranasal PH94B or placebo aerosol spray (double-blind) before repeat challenges.ResultsPatients who received PH94B during the second set of challenges had a significantly greater decrease in mean Subjective Units of Distress scores during the public speaking and social interaction challenges compared with the first set of challenges, than did patients who received placebo for both sets of challenges. A significantly greater proportion of the PH94B group were much or very much improved from the first to the second sets of challenges compared with the placebo group (75% and 37%, respectively). The side effects of PH94B were benign.ConclusionsPH94B may be a novel, effective, and well-tolerated acute treatment for performance and social anxiety in women with social anxiety disorder.