title: Effect of as-needed use of intranasal PH94B on social and performance anxiety in individuals with social anxiety disorder.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
authors: The Medical Research Network, LLC, New York, NY, USA.|Columbia University, Department of Psychiatry, New York City, New York, USA.
authors: Michael R
authors: MR
authors: Liebowitz
authors: Westport Compass, Salt Lake City, UT, USA.
authors: Rita
authors: R
authors: Hanover
authors: The Medical Research Network, LLC, New York, NY, USA.|Columbia University, Department of Psychiatry, New York City, New York, USA.
authors: Ann
authors: A
authors: Draine
authors: Pharmacyclics, Sunnyvale, CA, USA.
authors: Rita
authors: R
authors: Lemming
authors: The Medical Research Network, LLC, New York, NY, USA.|Columbia University, Department of Psychiatry, New York City, New York, USA.
authors: Jason
authors: J
authors: Careri
authors: Pherin Pharmaceuticals, Los Altos, CA, USA.
authors: Louis
authors: L
authors: Monti
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000737:Androstenols / Q000008:administration & dosage / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D060805:Performance Anxiety / Q000188:drug therapy*; D000072861:Phobia, Social / Q000188:drug therapy*; D010865:Pilot Projects; D012646:Self Administration; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C000590177:3-androsta-4,16-dien-3-ol; D000737:Androstenols
keywords: SAD/social anxiety disorder/social phobia; anxiety/anxiety disorders; pharmacotherapy; phobia/phobic disorders; treatment