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Vistagen Announces Positive Data in Fasedienol (PH94B) Phase 3 Open-Label Study in Adults with Social Anxiety Disorder
Long-term intranasal administration of fasedienol, used as-needed up to four times a day in daily life, was safe and well-tolerated in nearly 500 patients
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"\nLong-term intranasal administration of fasedienol, used as-needed up to four times a day in daily life, was safe and well-tolerated in nearly 500 patients with social anxiety disorder (SAD)\n\nPatients self-administered over 30,000 doses of fasedienol in real-world settings, with a mean study duration of 4 months, and a maximum study duration of over 10 months\n\nFasedienol demonstrated clinically meaningful reductions in fear, anxiety and avoidance of anxiety-provoking social and performance situations in daily life, as measured by the Liebowitz Social Anxiety Scale (LSAS), building on LSAS data from a previous placebo-controlled Phase 2 study of fasedienol in SAD\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\n\nVistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today announced positive data from its Phase 3 open-label study designed to evaluate the safety and tolerability of multiple, as-needed intranasal administrations of fasedienol (PH94B) over time in adults with social anxiety disorder (SAD). For the primary endpoint of safety and tolerability (safety population: n=481), the long-term administration of 3.2 µg of fasedienol, up to four times a day, as-needed, was safe and well-tolerated, with no new safety findings or trends identified, regardless of the number of doses administered by each subject. Secondary endpoints in the study included evaluation of the change from baseline on the Liebowitz Social Anxiety Scale (LSAS), which measures SAD patients’ response to anxiety-provoking social and performance situations experienced in their daily lives. Analysis of the final data set demonstrates clinically meaningful functional improvement, as measured by the LSAS, and total LSAS scores continued to decline in consecutive months during the study.\n\nThe safety and exploratory LSAS results of this Phase 3 open label study build on the safety and LSAS efficacy results from a previous randomized, double-blind, placebo-controlled Phase 2 study of fasedienol in a real-world setting. Results from that study suggested that self-administration of fasedienol on an as-needed basis prior to anxiety-provoking situations was accompanied by a persistent change in overall ...