Urovant Sciences Completes Patient Enrollment in Phase 3 Pivotal Trial Studying Vibegron for Overactive Bladder
- More than 1,500 patients enrolled in international Phase 3 clinical trial EMPOWUR, exceeding recruitment target
- Top-line efficacy and safety data from Phase 3 trial expected by the end of
“I am proud of the progress made since initiating our robust EMPOWUR clinical trial in March of 2018,” said Dr. Cornelia Haag-Molkenteller, Chief Medical Officer of Urovant. “Exceeding our enrollment ahead of schedule underscores the interest in this trial and reinforces the need for this significantly underserved patient population.”
EMPOWUR is a randomized, double-blind placebo- and active comparator controlled clinical trial in men and women with symptoms of overactive bladder, including frequent urination, sudden urge to urinate, and urge incontinence or leakage. Top-line efficacy and safety data are anticipated by the end of
A total of 1,530 patients who met the enrollment criteria were randomized across 216 study sites into one of three groups for a 12-week treatment period with a four-week safety follow up period: vibegron 75 mg administered orally once daily; placebo administered orally once daily; or tolterodine ER 4 mg administered orally once daily. Additionally, the first 507 patients who completed the EMPOWUR trial have been enrolled in a 40-week double-blind extension study to evaluate the safety of longer-term treatment.
The co-primary endpoints of the EMPOWUR study are:
- Change from baseline in the average number of micturitions per 24 hours in all patients
- Change from baseline in the average number of urge urinary incontinence (UUI) episodes per 24 hours in patients who have one or more UUI episodes per day prior to treatment
Vibegron, which has been widely studied and recently received regulatory approval in
In 2017, Urovant licensed global rights, excluding
About Overactive Bladder
Overactive bladder is a clinical condition characterized by the sudden urge to urinate that is difficult to control (urgency), with or without accidental urinary leakage (urge urinary incontinence), and usually with increased frequency of urination. The exact cause is unknown, making this a difficult condition to treat. In
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