Clinical TrialMay 12, 2026, 07:51 AM
Vistagen Reports Positive Preliminary Data from PALISADE-3 OLE
AI Summary
Vistagen Therapeutics announced preliminary positive data from the ongoing open-label extension (OLE) portion of its PALISADE-3 Phase 3 study of fasedienol for the acute treatment of social anxiety disorder. Fasedienol nasal spray was well-tolerated for up to 12 months of as-needed use, with no new drug-related safety findings. Exploratory efficacy data over four months showed clinically relevant improvements in social anxiety on both clinician-administered (LSAS) and patient-reported (SPIN) scales.
Key Highlights
- Fasedienol was well-tolerated for up to 12 months of as-needed use in the open-label extension (OLE) of PALISADE-3.
- Discontinuation due to adverse events was 2.6% (9/341), with none attributed to fasedienol.
- Mean LSAS improvement was 25.4 points at Month 4 (n=228), with 56% achieving ">= 20-point improvement."
- Mean SPIN improvement was 12.4 points at Month 4 (n=228), with 55% achieving ">= 10-point improvement."
- No new drug-related safety findings or trends were identified after up to 12 months of use.
- The most common TEAEs were headache (10.9%) and upper respiratory infection (11.4%).
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