Effect of as-needed use of intranasal PH94B on social and performance anxiety in individuals with social anxiety disorder

• Published in: Depression and anxiety Vol. 33; no. 12; pp. 1081 - 1089
• Main Authors: Liebowitz, Michael R., Hanover, Rita, Draine, Ann, Lemming, Rita, Careri, Jason, Monti, Louis
• Format: Journal Article
• Language: English
• Published: United States Blackwell Publishing Ltd 01.12.2016; Hindawi Limited
• Subjects: Administration, Intranasal; Adolescent; Adult; Aged; Androstenols - administration & dosage; Androstenols - therapeutic use; Anxiety; anxiety/anxiety disorders; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Performance Anxiety - drug therapy; pharmacotherapy; Phobia, Social - drug therapy; phobia/phobic disorders; Pilot Projects; SAD/social anxiety disorder/social phobia; Self Administration; Shyness; treatment; Treatment Outcome; Young Adult; treatment; SAD/social anxiety disorder/social phobia; anxiety/anxiety disorders; pharmacotherapy; phobia/phobic disorders
• ISSN: 1091-4269; 1520-6394
• DOI: 10.1002/da.22546

Background There are no medications approved for as‐needed use for feared situations for individuals with social anxiety disorder (SAD). In the present study, intranasal PH94B was provided for use as needed during stressful events. Methods Twenty‐two subjects were randomized (double‐blind) to 2 weeks of treatment with intranasal PH94B or placebo. Following self‐administration of medication prior to a feared event, peak levels of anxiety were recorded using the Subjective Units of Distress Scale (SUDS). After 2 weeks, subjects were crossed over to the opposite treatment for 2 weeks. Average peak SUDS during treatment with PH94B and placebo were compared using a paired t‐test. Results Significant differences in favor of PH94B were found on the primary outcome measure: mean peak SUDS change from baseline for all subjects receiving PH94B was 15.6 points versus 8.3 points for placebo (paired t = 3.09, P = .006, effect size of .658). PH94B showed less superiority over placebo when placebo was given second rather than first, likely due to a carryover effect. Looking between groups at just the first 2 weeks of treatment, PH94B also showed trend superiority to placebo on the Liebowitz Social Anxiety Scale (LSAS) (P = .07) and a significant difference on the Patient Global Impression of Change (P = .024) and the LSAS Avoidance subtotal (P = .02). Conclusions While further study is needed, these results, combined with earlier findings, suggest that PH94B could represent a useful as‐needed treatment for SAD, and continue to validate the nasal chemosensory system as a novel mechanism for medication delivery.