Feasibility Study of PH94B Nasal Spray for Acute Treatment of Social Anxiety Disorder (SAD)

Summary

The purpose of the study is to determine whether the PH94B nasal spray is effective for Acute Treatment of the symptoms of Social Anxiety Disorder (SAD) in adult men and women. The hypothesis is that PH94B nasal spray (.8 micrograms) has a rapid onset of efficacy to improve performance and interaction anxiety in patients with diagnosed Social Anxiety Disorder (SAD).

Timeline

Start

2014-03

Primary completion

2014-10

Completion

2015-03

Outcome

Met primary endpoint

paper Significant differences in favor of PH94B were found on the primary outcome measure PMID 27561175 ↗

paper PH94B was 15.6 points versus 8.3 points for placebo (paired t = 3.09, P = .006, effect size of .658). PMID 27561175 ↗

release “pilot Phase 3 crossover study, subjects receiving PH94B had a significantly greater decrease in average peak Subjective Units of Distress scores compared to placebo” vistagen.com ↗

release “In both Phase 2 and pilot Phase 3 clinical studies, PH94B was more effective than placebo in the whole sample on the primary outcome measure.” vistagen.com ↗

Publications

• Liebowitz MR, Hanover R, Draine A, Lemming R, Careri J, Monti L. Effect of as-needed use of intranasal PH94B on social and performance anxiety in individuals with social anxiety disorder. Depress Anxiety. 2016 Dec;33(12):1081-1089. doi: 10.1002/da.22546. Epub 2016 Aug 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fasedienol	Small molecule	1.6 ug	Intranasal
Subject	Fasedienol	Small molecule	3.2 ug	Intranasal

Indications