Vistagen Therapeutics Says Fasedienol Nasal Spray Well-Tolerated With No New Drug-Related Safety Findings After 12 Months
VTGN•Preliminary positive PALISADE-4 extension data
Sept. 22 (Reuters) - Vistagen Therapeutics, Inc. VTGN.O:
- Vistagen announced preliminary positive data from the open-label extension portion of the PALISADE-4 phase 3 study of fasedienol for the acute treatment of social anxiety disorder.
- Fasedienol nasal spray was well-tolerated, with no new drug-related safety findings after 12 months.
- No serious adverse events related to fasedienol were reported.
- The discontinuation rate due to adverse events was 1.6%, and none were attributed to fasedienol.
- Vistagen said it is preparing to meet with the FDA this quarter for a proposed new phase 3 trial.
