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Urovant Sciences announces publication in the Journal of Urology of the Phase III EMPOWUR trial of vibegron for overactive bladder .

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Published:10th Mar 2020
Urovant Sciences announced the publication of the efficacy and safety results of vibegron in patients with overactive bladder (OAB) from the international Phase III EMPOWUR trial. The peer-reviewed publication is currently available online and the print article is scheduled to be published in the August issue of Journal of Urology. The double-blind, placebo-controlled 12-week trial, in patients with OAB, studied vibegron 75 mg once-daily compared to placebo and included an active control. In the trial, vibegron achieved rapid onset of action at two weeks in both co-primary endpoints and daily urgency episodes and statistically significant efficacy was maintained at all timepoints measured through the end of the study. Vibegron also achieved statistical significance over placebo on all 7 key secondary endpoints, including the most important secondary endpoint of reduction in urgency episodes. Vibegron demonstrated consistent efficacy, a favorable safety profile, and was well tolerated. The frequency of serious adverse events was similar across treatment arms and the incidence of the reported adverse event of hypertension for vibegron was equal to placebo. The New Drug Application (NDA) seeking approval of once-daily 75 mg vibegron for the treatment of patients with overactive bladder (OAB) was submitted to the FDA in December 2019. “Over 30 million people in the U.S. suffer from OAB symptoms and many patients are unable to find relief,” said Dr. David Staskin, a key investigator in the EMPOWUR study, a leading urologist with St. Elizabeth’s Medical Center, and an Associate Professor of Urology at Tufts University School of Medicine in Boston. “The results of this clinical trial have demonstrated that vibegron, if approved by the FDA, could provide an important new oral treatment for patients suffering with OAB.” See:"International Phase III, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR":David Staskin, Jeffrey Frankel, Susann Varano, Denise Shortino, Rachael Jankowich, and Paul N. Mudd
Condition: Overactive Bladder
Type: drug

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