Urovant Sciences announced new analyses from the Phase 3 EMPOWUR Extension Study of GEMTESA, presented Sunday at the 2022 annual meeting of the American Urological Association (AUA2022). The meeting is being held in New Orleans from May 13-16, 2022. Two podium presentations at AUA2022 on May 15 featured new analyses of data from the EMPOWUR 40-week extension trial of GEMTESA (vibegron) 75 mg.

This was a Phase 3, randomized, double-blind, active-comparator controlled, parallel-group multicenter study to evaluate long-term safety and efficacy in patients with symptoms of OAB. GEMTESA is approved by the U.S. Food and Drug Administration for the treatment of OAB symptoms of UUI, urgency, and urinary frequency in adults. The first podium presentation, PD38-11, presented at 8:40-8:50 a.m. by Jeffrey Frankel, MD, Medical Director, Seattle Urology Research Center, Seattle, Washington, is titled, “Long-Term Efficacy and Safety of Vibegron for Overactive Bladder in Patients =65 Years Old: Analysis from the EMPOWUR Extension Trial.” In a subgroup analysis of adults, 65 years old or above with overactive bladder, treatment with GEMTESA was safe and well tolerated.

Treatment with GEMTESA was associated with sustained reductions from baseline in average daily micturition, UUI episodes, and urgency episodes. These results were consistent with the overall EMPOWUR Extension Study population.