Topline results show fasedienol nasal spray reduces symptoms in social anxiety disorder

Key takeaways:

• Participants in the phase 3 trial were significantly less anxious during a public speaking challenge after treatment with fasedienol.
• Fasedienol was well-tolerated with no severe or serious adverse events.

Fasedienol, a nasal spray for treatment of adults with social anxiety disorder, was efficacious and well-tolerated in a phase 3 trial, according to topline results announced in a press release from developer Vistagen.

In the release, CEO Shawn Singh said the company is “thrilled” with the positive results on what he said could be “the first fundamentally new class of medicine” for social anxiety disorder in more than 20 years.

“As a new class of medicines, our pherine nasal spray pipeline holds the potential to transform the treatment landscape across numerous therapeutic areas,” Singh said, adding that fasedienol is “at the head of that class.”

In the multicenter, double-blind PALISADE-2 trial, participants diagnosed with social anxiety disorder engaged in a simulated, anxiety-provoking public speaking challenge at baseline and repeated the challenge after treatment with fasedienol (n = 70) or placebo (n = 71). Researchers measured patients’ anxiety during the challenges using the Subjective Units of Distress Scale (SUDS) and compared scores before and after treatment.

According to the release, patients treated with fasedienol had a statistically significant greater change in mean SUDS score vs. placebo (least-squares mean –13.8 vs. –8; difference –5.8).

Researchers also reported a statistically significant difference in the percentage of fasedienol-treated patients assessed by clinicians as “very much less anxious” or “much less anxious” on the Clinical Global Impressions Improvement scale compared with placebo (37.7% vs. 21.4%).

No severe or serious adverse events were reported, the release stated, with all treatment-emergent adverse events being mild or moderate. Adverse events in the fasedienol treatment arm were reported in no more than 2% of participants.

According to Vistagen, the PALISADE-2 trial was paused with 141 patients enrolled, and ultimately closed, following topline results from PALISADE-1, in which fasedienol did not meet its primary endpoint: change in SUDS score from baseline during a public speaking challenge.

A future phase 3 study will involve multiple administrations of fasedienol over several weeks on an as-needed basis determined by patients, Michael R. Liebowitz, MD, director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute, said in the release.

Reference:

• Vistagen announces topline results from PALISADE-1 phase 3 clinical trial for investigational drug PH94B. https://www.vistagen.com/news-releases/news-release-details/vistagen-announces-topline-results-palisade-1-phase-3-clinical. Published July 22, 2022. Accessed Aug. 10, 2023.