Urovant Sciences to Announce Topline Results from the EMPOWUR Phase 3 Study of Vibegron in Patients with Overactive Bladder
The conference call numbers are (866) 470-1049 for domestic callers and +1 (409) 217-8245 for international callers. The conference ID is 9455883. The webcast link to view the presentation is available at: https://edge.media-server.com/m6/p/oey7muvz.
A replay of the call will be available approximately four hours after the call and accessible for 30 days at (855) 859-2056 for domestic callers and +1 (404)-537-3406 for international callers. The conference ID is 9455883. A webcast will be archived on the Investor Relations page of the
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 the
EMPOWUR is an international randomized, double-blind placebo- and active comparator controlled clinical trial evaluating the safety and efficacy of investigational vibegron in men and women with symptoms of overactive bladder, including frequent urination, sudden urge to urinate, and urge incontinence or leakage. A total of 1,518 patients were randomized across 215 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, 507 patients who completed the EMPOWUR trial were 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; and 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. Secondary endpoints included changes in the frequency of urinary urgency episodes and incontinence episodes, and self-reported quality of life scores.
About Roivant Sciences
Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, please visit www.roivant.com.
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2. Kinsey D, et al., J Health Psychol. 2016
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