VistaGen says Phase 2 repeat-dose fasedienol study in social anxiety disorder shows favorable safety, efficacy signals

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


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