Vistagen’s anxiety nasal spray fails to outperform placebo in Phase 2 study

Vistagen reported results of its Phase 2 trial of the investigational nasal spray fasedienol for social anxiety disorder.

The study enrolled 61 patients who were randomly assigned to receive a single dose of fasedienol followed by placebo, two consecutive doses of fasedienol, or two placebo sprays, with administrations ten minutes apart.

Across all three arms, neither fasedienol dose produced a statistically significant reduction in self‑assessed distress or anxiety during a public‑speaking challenge, and pooled results from both fasedienol groups also showed no advantage over placebo.

Vistagen said the trial was not designed to demonstrate statistical significance and that it will meet with the FDA to discuss a potential registrational pathway for the asset.