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Depress Anxiety. 2016 Dec;33(12):1081-1089. doi: 10.1002/da.22546. Epub 2016 Aug 25.

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

Author information

1
The Medical Research Network, LLC, New York, NY, USA.
2
Columbia University, Department of Psychiatry, New York City, New York, USA.
3
Westport Compass, Salt Lake City, UT, USA.
4
Pharmacyclics, Sunnyvale, CA, USA.
5
Pherin Pharmaceuticals, Los Altos, CA, USA.

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02622958.

KEYWORDS:

SAD/social anxiety disorder/social phobia; anxiety/anxiety disorders; pharmacotherapy; phobia/phobic disorders; treatment

PMID:
27561175
DOI:
10.1002/da.22546
[Indexed for MEDLINE]

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