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P06_NonCE - 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)

Purpose: Results are reported for the 40-week extension to the phase 3 randomized, double-blind, 12-week EMPOWUR trial of OAB patients.

Background/significance: Vibegron is a novel, oral, once-daily β3 agonist being investigated for OAB treatment. In EMPOWUR (N=1518), vibegron 75 mg statistically significantly improved co-primary OAB endpoints of daily micturitions and urged urinary incontinence (UUI) (p5% for vibegron; vibegron/tolterodine) were hypertension (8.8%/8.6%), urinary tract infection (6.6%/7.3%), and headache (5.5%/3.9%). One death (due to arteriosclerotic disease, judged not related to study drug by investigators or sponsor) occurred in the vibegron group. EMPOWUR vibegron and tolterodine patients showed improvement in adjusted mean change from baseline at week 52 in micturitions (-2.4, vibegron/-2.0, tolterodine), UUI (-2.2/-1.7), urgency (-3.4/3.2), and total incontinence (-2.5/-1.9); 61.0% of 143 vibegron patients had ≥75% UUI reduction, and 40.8% became dry (100% reduction) at week 52.

Conclusions/implications: Vibegron demonstrated favorable long-term safety in extension patients and showed durable improvements in micturitions, and UUI, urgency, and total incontinence episodes; 40.8% of OAB-wet patients became dry at week 52.

Funding: Urovant Sciences