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Preliminary PALISADE-4 open-label extension data for fasedienol nasal spray suggest it was well-tolerated up to 12 months, with exploratory improvements on LSAS and SPIN over four months. Company plans to meet the FDA to consider a new registrational Phase 3.
Vistagen said fasedienol nasal spray was well-tolerated in social anxiety disorder patients, with no new drug-related safety findings after as-needed use for up to 12 months. The company reported clinically relevant improvements over time on clinician- and patient-reported scales during the open-label extension portion