Vistagen announced preliminary positive findings from the open-label extension of its PALISADE-3 Phase 3 study of fasedienol nasal spray for social anxiety disorder treatment. The compound demonstrated sustained tolerability and clinically relevant improvement in anxiety symptoms over four months of real-world use.
Safety Profile
In the open-label extension involving 341 subjects, fasedienol taken as-needed up to six times daily was well-tolerated with no new drug-related safety findings. The discontinuation rate due to adverse events was 2.6% (9 of 341), with no discontinuations attributed to fasedienol itself. More than 95% of treatment-emergent adverse events were mild or moderate in severity. Headache occurred in 10.9% of subjects (37 of 341) and upper respiratory infection in 11.4% (39 of 341). No serious adverse events related to fasedienol were reported.
Clinical Improvement
Exploratory efficacy data over the first four months demonstrated clinically relevant improvement on both the Liebowitz Social Anxiety Scale (LSAS) and the Social Phobia Inventory (SPIN). At baseline, mean LSAS scores were 99.2 (n=341), indicating very severe social anxiety. By month 4, mean improvement on the LSAS reached 25.4 points (n=228), with 56% of subjects achieving a 20-point or greater improvement. On the SPIN, baseline mean score was 48.7 (n=341); at month 4, mean improvement was 12.4 points with 55% of subjects achieving a 10-point or greater improvement.
Study Context
The PALISADE-3 randomized double-blind, placebo-controlled portion did not meet its primary endpoint in December 2025. However, subjects who elected to continue in the open-label extension could self-administer fasedienol in daily anxiety-provoking situations for up to 12 months. Vistagen believes these interim safety and efficacy results could support a potential New Drug Application submission to the FDA for the acute treatment of social anxiety disorder if PALISADE-4 results are successful.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/vistagen-announces-preliminary-positive-data-in-ongoing-open-label-extension-portion-of-palisade-3-phase-3-study-of-fasedienol-for-the-acute-treatment-of-social-anxiety-disorder