Urovant Sciences Presents Positive Pivotal Data for Vibegron During Plenary Session at American Urological Association Annual Meeting
- Pivotal Phase 3 EMPOWUR study met both co-primary endpoints, with significant reduction in daily urge urinary incontinence episodes and micturitions, compared to placebo (p<0.0001 and p<0.001, respectively), and a favorable safety and tolerability profile
- Efficacy observed at week 2 and maintained through week 12 in co-primary endpoints
- Data showed once-daily 75 mg dose has potential to be an efficacious agent for disruptive overactive bladder symptoms for broad base of patients
Data from EMPOWUR – an international double blind, placebo-controlled, multicenter Phase 3 clinical trial evaluating the efficacy and safety of a once-daily 75 mg dose of vibegron – showed statistical significance over placebo in both reduction in daily urge urinary incontinence (UUI) episodes (p<0.001) and reduction in daily micturitions (p<0.001). The difference compared to placebo was statistically significant as early as week 2 for UUI and micturitions (p<0.001 and p<0.001, respectively) and statistically significant efficacy was maintained at all timepoints measured through the end of the study. In addition, vibegron met all seven key secondary endpoints, including a clinically meaningful reduction in daily urgency episodes and volume voided versus placebo.
A patient subset-analysis of the data were also included in the plenary presentation at AUA, showing vibegron reduced UUI and micturitions in patients previously treated for OAB symptoms with an anticholinergic or mirabegron, the only currently marketed beta-3 agonist.
“There is a need for a new treatment option with rapid onset in a once-daily, convenient dose for patients suffering from OAB symptoms,” said Dr. Staskin. “The EMPOWUR data suggests that vibegron, if approved, could be suitable for a large base of patients.”
Urovant intends to file a New Drug Application (NDA) with 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 and efficacy 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; and change from baseline in the average number of urge urinary incontinence (UUI) episodes per 24 hours in patients who have an average of 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 Overactive Bladder
Overactive bladder (OAB) 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
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