Vistagen announces data in fasedienol Phase 3 open-label study

Vistagen 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 over time in adults with social anxiety disorder. For the primary endpoint of safety and tolerability, the long-term administration of 3.2 microgram 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, 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. "The safety profile and potential for fasedienol to achieve overall reduction in symptoms of SAD and improvement in severity of the disorder, as measured by the LSAS, have now been demonstrated in a placebo-controlled Phase 2 study after two weeks of use, as well as in this open-label study over a period of one month and beyond," said Shawn Singh, Chief Executive Officer of Vistagen. "We believe these data suggest that studies involving multiple administrations of fasedienol over time, on an as-needed basis at moments when subjects experience real-life, socially stressful situations, most accurately demonstrate the safety and efficacy potential of fasedienol in patients with SAD and reflect the way we believe fasedienol would be used by SAD patients, if approved. Each SAD patient is unique, and we believe an optimal SAD treatment is one that is individualized and tailored-to-fit by patients, as-needed, to help them engage in the anxiety-provoking situations they encounter in their daily lives with less fear and anxiety."