AUA 2019: International Phase 3, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms in patients with Symptoms of Overactive Bladder: EMPOWUR

Chicago, IL ( The purpose of the presentation was to introduce a novel, highly selective oral beta-3-androgen receptor agonist for the treatment of overactive bladder (OAB). Previous Phase 2 and 3 studies demonstrate rapid and sustained efficacy of vibegron. No significant drug interaction was indicated on pharmacokinetic trials.

EMPOWUR is an international Phase 3, double-blind, placebo- and active (tolterodine)-controlled study of vibegron in OAB wet and dry patients. A total of 1,518 eligible participants were randomized to 75 mg vibegron, placebo, and extended-release 4 mg tolterodine that acted as positive control (Table 1). 

Table 1
AUA 2019 vibegron in OAB wet and dry patients

Primary endpoints included a change in the average number of daily urge urinary incontinence (UUI) episodes in patients with 1 or more episodes per day and change in daily urinary voids. Subjects were followed for 12 weeks with 4 weeks of safety assessment.

Data analysis showed a statistically significant reduction in UUI episodes (Figure 1) and the daily number of voids (Figure 2) in vibegron group compared to placebo.

Figure 1
AUA 2019 reduction in UUI episodes

Figure 2
AUA 2019 daily micturitions

In addition, vibegron significantly increased urine volume per void by 21 ml compared to placebo at 12-week assessment (p<0.0001). A limited number of adverse events was noted (Table 2).

Table 2
AUA 2019 safety population

In conclusion, vibegron provided a significant improvement on OAB symptoms. It was well tolerated in subpopulations based on age and prior anticholinergic use with minimal adverse events compared to placebo.

Presented by: David Staskin, MD, Tufts University School of Medicine, Boston, Massachusetts 

Written by: Hanna Stambakio, BS, Clinical Research Coordinator, Division of Urology, University of Pennsylvania @AStambakio at American Urological Association's 2019 Annual Meeting (AUA 2019), May 3 – 6, 2019 in Chicago, Illinois
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