Once-Daily Vibegron 75 mg for Overactive Bladder: Double-Blind 52-Week Results From an Extension Study of the International Phase 3 Trial (EMPOWUR)

Staskin D1, Frankel J2, Varano S3, Shortino D4, Jankowich R4, Mudd Jr P4

1. Tufts University School of Medicine, Boston, MA, 2. Seattle Urology Research Center, Seattle, WA, 3. Clinical Research Consulting, Milford, CT, 4. Urovant Sciences, Irvine, CA

KEYWORDS: Overactive Bladder, Incontinence, Quality of Life (QoL), Urgency/Frequency, Voiding Dysfunction

Vibegron is a novel, highly selective, oral, once-daily β3-adrenergic receptor agonist being investigated for overactive bladder (OAB) treatment. In the phase 3 randomized, double-blind, 12-week EMPOWUR trial (N=1518), vibegron 75 mg statistically significantly improved co-primary OAB endpoints of change from baseline to week 12 in average daily number of micturitions and urgency urinary incontinence (UUI) episodes (p0.001 for each) and key secondary endpoints vs placebo; tolterodine extended-release 4 mg was active control. Vibegron tolerability was favorable. Results from the 40-week EMPOWUR extension study are reported.

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