Neuroactive Nasal Spray Promising Treatment for SAD

Fasedienol (PH94B), a neuroactive nasal spray, was found to be an effective treatment for social anxiety disorder (SAD) in a phase 3 trial, according to poster findings presented at the NEI Congress in Colorado Springs, Colorado, from November 9-12, 2023. This phase 3 study followed promising results in previous trials. 

“The phase 3 PALISADE-2 trial results demonstrated that a single dose of fasedienol prior to a stressful [public speaking challenge (PSC)] reduced anxiety levels as measured by [Subjective Units of Distress Scale (SUDS)] scores,” researchers noted. “The results also confirm the nasal-amygdala neural circuits as a new portal for administration of pharmaceuticals and support the continued development of fasedienol as a first-in-class, rapid-onset, well-tolerated treatment for SAD without addictive properties.”

Related: Intranasal Fasedienol Safe, Well-Tolerated in Adults With Social Anxiety Disorder

The multicenter, double-blind, randomized, placebo-controlled study included 141 adults with SAD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Researchers divided the study up into 4 participant visits:

• Visit 1: Participants were screened, and researchers ensured eligibility criteria were met. 
• Visit 2: Participants received placebo nasal spray and participated in a 5-minute PSC. Researchers recorded SUDS scores before and during the PSC. 
• Visit 3: Participants who had SUDS scores of 75 or more during the visit 2 PSC were brought back and randomized to receive either placebo or fasedienol nasal spray (3.2 μg intranasally; 1.6 μg in each nostril). Participants then again took part in a PSC with SUDS scores being recorded.
• Visit 4: As part of follow-up, trained raters completed a Clinical Global Impression of Improvement (CGI-I) assessment and participants completed a Patient Global Impression of Change (PGI-C) questionnaire.

Average SUDS scores were calculated for each participant at each PSC.

Of the participants, 70 received fasedienol and 71 received the placebo nasal spray. Participants who were administered fasedienol showed a greater reduction in mean SUDS score (mean change: −13.8) than placebo-treated participants (mean change: −8.0), with a mean difference of −5.8 (P=0.015). Fasedienol participants also had a higher CGI-I response (37.7% vs 21.4%; P=0.033) and PGI-C response (40.6% vs 18.6%; P=0.003) than participants who received the placebo. Treatment emergent adverse events occurred in 1 participant, though no other severe or serious adverse events were reported. 

This study was funded by Vistagen Therapeutics, Inc.

Reference
Liebowitz MR, Salman E, Hanover R, et al. Top-Line results from Phase 3 PALISADE-2 trial of fasedienol (PH94B) nasal spray in social anxiety disorder. Poster presented at NEI Congress; November 9-12, 2023; Colorado Springs, Colorado.