Vistagen's anxiety nasal spray fails to outperform placebo in phase 2 trial

Vistagen Therapeutics reported that its experimental nasal spray fasedienol did not show a statistically significant advantage over placebo in a phase 2 study of social anxiety disorder.

The trial enrolled 61 participants who faced a public-speaking challenge. Patients received either a single puff, a double puff of the drug, or matching placebo. On the primary endpoint, reduction in anxiety measured by the subjective units of distress scale, the double dose lowered scores by 15.4 points, the single dose by 14.7 points, versus 6.8 points for placebo.

The company noted the study was not powered to detect a difference and highlighted a subgroup of patients where the drug appeared to perform better, suggesting a potential path toward FDA approval.