Urovant Sciences Presents Positive Clinical Efficacy & Safety Data on Lead Drug Candidate Vibegron at Virtual American Urological Association Annual Meeting
52-Week Post Hoc Analysis Shows Vibegron Patients Had Statistically Significant, Sustained Reduction in UUI and Total Incontinence Episodes Compared to Active Control
The data sets that will be presented support the potential benefits of vibegron for the treatment of overactive bladder (OAB) in patients with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency, if approved by the
Vibegron is a once-daily, beta-3 adrenergic agonist under investigation for the treatment of OAB. Twelve-week data from the EMPOWUR study were previously presented at the annual AUA meeting in 2019. These data demonstrated statistically significant improvements in the co-primary OAB endpoints of daily urination (micturitions) and UUI, and key secondary endpoints, including urgency episodes, in patients treated with vibegron 75 mg vs placebo. The data also demonstrated a favorable safety and tolerability profile.
The first Urovant presentation focuses on the 52-week results from the double-blind vibegron 75 mg EMPOWUR extension study. In this study, patients receiving treatment with 75 mg vibegron experienced sustained reductions in daily micturitions, UUI, urgency, and total urinary incontinence episodes over the 52-week period. Vibegron also demonstrated a favorable long-term safety profile over the 52 weeks. In addition, in a post hoc analysis, vibegron showed a statistically significant reduction in UUI and total incontinence episodes, from baseline to 52 weeks, compared to the active control, tolterodine.
“The results of the EMPOWUR study over the 52-week period demonstrated the sustained benefits of vibegron. Vibegron could be a potentially important and differentiated new oral treatment, if approved by the FDA, for patients suffering with OAB,” said
The second Urovant presentation examines data from the international, double-blind vibegron 75 mg 12-week EMPOWUR study by age, with a focus on older patients. For patients aged 65 years and older, statistically significant improvements were seen with 75 mg vibegron compared with placebo in the co-primary endpoints of micturitions and UUI episodes, as well as key secondary endpoints, including urgency episodes. Overall, adverse event rates were comparable between older patients and the total study population.
“The EMPOWUR 12-week study efficacy and safety results in patients age 65 and older are encouraging, and important because the prevalence of OAB increases with age,” said
Both presentations can be accessed on the annual meeting website on
Virtual Presentation Details:
Session Title: Urodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Non-Neurogenic Voiding Dysfunction I
Abstract Number 01: Once-Daily Vibegron 75 mg for Overactive Bladder (OAB): Double-Blind 52-Week Results from an Extension Study of the International Phase 3 Trial (EMPOWUR). The abstract is available to view here.
Abstract Number 02: Efficacy of once-Daily Vibegron 75 mg for Overactive Bladder (OAB) in Older Patients: The EMPOWUR Randomized, International, Phase 3 Study. The abstract is available to view here.
About the Phase 3 Trial
The EMPOWUR trial was 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.
About the 40-Week Extension
The EMPOWUR 40-week extension trial was a phase 3, randomized, double-blind, active controlled multicenter study to evaluate the long-term safety and efficacy of vibegron in patients with symptoms of overactive bladder. The extension study enrolled approximately 500 EMPOWUR completers. Key efficacy endpoints were changes from EMPOWUR baseline at week 52 in average daily micturitions, UUI, urgency, and total urinary incontinence.
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