VistaGen says Phase 2 repeat-dose fasedienol study in social anxiety disorder shows favorable safety, efficacy signals
VTGN•Safety findings
Safety met the study objective, with repeat dosing showing tolerability comparable to a single dose and no new safety issues.
Efficacy signals
Efficacy signals favored fasedienol over placebo on the main anxiety measure, though the trial was not designed to show statistically significant differences.
Topline Phase 2 results
VistaGen released topline results from an exploratory Phase 2 repeat-dose study of fasedienol nasal spray for acute social anxiety triggered by public speaking.
Severe subgroup and regulatory path
A prespecified very severe subgroup showed a nominally significant improvement with fasedienol, supporting FDA discussions on a potential registrational pathway.
