VistaGen Therapeutics Inc (VTGN) on Tuesday announced preliminary positive data from the ongoing open-label extension portion of its Phase 3 PALISADE-3 study evaluating fasedienol for the acute treatment of social anxiety disorder.
The study assessed changes from baseline on the Liebowitz Social Anxiety Scale (LSAS), a clinician-administered measure evaluating fear and avoidance associated with social anxiety disorder. Patients treated with fasedienol showed improvements in both fear and avoidance subscales over time.
The open-label extension also evaluated changes on the Social Phobia Inventory (SPIN), a patient-reported scale measuring fear, avoidance and physiological symptoms of social phobia. According to the company, the initial four-month analysis showed clinically relevant improvement over time in patients participating in the extension study.
Fasedienol nasal spray, administered as needed up to six times daily, was observed to be well tolerated in adults with social anxiety disorder. The discontinuation rate due to adverse events was 2.6%, with no discontinuations attributed to fasedienol.
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