The double-blind, placebo-controlled trial included 141 participants, with 70 receiving fasedienol and 71 receiving a placebo.
The phase 3 PALISADE-2 trial has recently evaluated the efficacy of fasedienol nasal spray, a first-in-class, rapid-onset investigational treatment, in adults diagnosed with social anxiety disorder (SAD). The study’s findings reveal promising results in reducing anxiety symptoms, particularly during public speaking challenges.
- The primary endpoint was the difference in Subjective Units of Distress Scale (SUDS) score during a public speaking challenge.
- Treatment with fasedienol showed a statistically significant difference in average SUDS score compared to placebo (difference of -5.8; P =.015).
- 37.7% of fasedienol-treated patients were rated as responders, compared to 21.4% of placebo recipients (P =.033).
- The treatment was reported to have a favorable safety profile.
- The trial has been stopped due to business reasons, with further analysis of the data ongoing.
- A future phase 3 study will explore multiple administrations of fasedienol over several weeks.
- Fasedienol nasal spray has demonstrated potential as an effective treatment for SAD, with significant reductions in anxiety symptoms and a favorable safety profile.