Effect of an acute intranasal aerosol dose of PH94B on social and performance anxiety in women with social anxiety disorder
Abstract
OBJECTIVE: Although 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. METHOD: The 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. RESULTS: Patients 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. CONCLUSIONS: PH94B may be a novel, effective, and well-tolerated acute treatment for performance and social anxiety in women with social anxiety disorder.
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Fasedienol has shown robust efficacy in the acute treatment of SAD in phase 2 and phase 3 clinical studies.
“fasedienol has shown robust efficacy in the acute treatment of SAD in phase 2 and phase 3 clinical studies”
From Effect of fasedienol (PH94B) pherine nasal spray and steroidal hormones on electrogram responses and autonomic nervous system activity in healthy adult volunteers (2024) · cites this paper as Liebowitz et al., 2014
Fasedienol is proposed to bind peripheral receptors in nasal chemosensory mucosa that in turn activate subsets of olfactory bulb neurons to modulate olfactory-amygdala neural circuits.
“Fasedienol, which is formulated as a nasal spray and is being investigated for the acute treatment of SAD, is proposed to bind peripheral receptors in nasal chemosensory mucosa that in turn activate subsets of olfactory bulb neurons to modulate olfactoryamygdala neural circuits (Liebowitz et al., 2014;Monti & Liebowitz, 2022).”
From Effect of fasedienol (PH94B) pherine nasal spray and steroidal hormones on electrogram responses and autonomic nervous system activity in healthy adult volunteers (2024) · cites this paper as Liebowitz et al., 2014
Concordance of efficacious plasma concentration between rodents and non-human primates has been reported in previous studies for other α7-nAChR agonists, including BMS-933043 and EVP-6124.
“The concordance of efficacious plasma concentration between rodents and non-human primates has been reported in previous studies for other α7-nAChR agonists, including BMS-933043 and EVP-6124. 29,31”
In a randomised clinical trial, 15 min after intranasal application, aloradine reduced performance anxiety and social interaction anxiety to a greater extent than placebo in a provoked public-speaking challenge in female patients diagnosed with generalised SAD.
“Liebowitz and co-workers reported the results of a randomised clinical trial demonstrating that 15 min after its intranasal application, aloradine already reduced performance anxiety and social interaction anxiety to a greater extent than a placebo in a provoked public-speaking challenge in female patients diagnosed with generalised SAD (Liebowitz et al., 2014).”
From Novel pharmacological targets in drug development for the treatment of anxiety and anxiety-related disorders (2019) · cites this paper as Liebowitz et al., 2014
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- Authors
- Liebowitz, M. R., Salman, E., Nicolini, H., Rosenthal, N., Hanover, R., & Monti, L.
- Affiliations
- Westchester Medical Center (US)
- From the Medical Research Network, New York, and the Department of Psychiatry, Columbia University, New York; ChiMatrix, Scarsdale, N.Y.; Carracci Medical Group, Mexico City; the Department of Psychiatry, Georgetown University Medical School, Washington, D.C.; Capital Clinical Research Associates, Rockville, Md.; Westchester Medical Center, Valhalla, N.Y.; and Pherin Pharmaceuticals, Los Altos, Calif.
- Venue
- American Journal of Psychiatry
- Published
- 2014-06
- Volume
- 171
- Issue
- 6
- Pages
- 675-682
- ISSN
- 0002-953X (ISSN-L)
- 1535-7228
- OpenAlex
- W2033250382
- Cited by
- 36
- References
- 33
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 7 · 2023: 2 · 2022: 1 · 2021: 6 · 2020: 3 · 2019: 2 · 2018: 1 · 2017: 2 · 2016: 3 · 2015: 3 · 2014: 1
- FWCI
- 4.16
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Journal of Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Life Sciences › Neuroscience › Behavioral Neuroscience › Stress Responses and Cortisol
- Health Sciences › Medicine › Complementary and alternative medicine › Medicinal Plant Extracts Effects
- Keywords
- social anxiety disorder, neurosteroids, performance anxiety, social anxiety, women, public speaking, social interaction, subjective units of distress, as-needed treatment
- MeSH terms
- Administration, Intranasal, Adolescent, Adult, Aerosols, Aged, Androstenols, Female, Humans, Interpersonal Relations, Middle Aged, Phobic Disorders, Psychiatric Status Rating Scales, Psychological Tests, Anti-Anxiety Agents, Treatment Outcome, Young Adult
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