In this international, double-blind, placebo- and active comparator-controlled trial patients (N=1518) were randomized to 1 of 3 groups for a 12-week treatment period plus a 4-week safety period: vibegron 75mg once daily, placebo once daily, or tolterodine extended-release 4mg once daily.
Results showed that vibegron was associated with a statistically significant reduction in daily urge urinary incontinence episodes (P<.0001) and daily micturitions (P<.001) compared with placebo (co-primary endpoints). Moreover, statistical significance was achieved as early as week 2 (first time point measured) for both outcomes, and statistically, significant efficacy was maintained for all time points through the end of the study. Compared with tolterodine, treatment with vibegron led to numerically superior efficacy at all measured time points.
Regarding safety, vibegron was well tolerated among study patients; headache, nasopharyngitis, diarrhoea, and nausea were the most common adverse reactions reported.
Full data from the EMPOWUR study will be presented at the upcoming American Urological Association Meeting in Chicago.
Vibegron, an oral small molecule beta-3 adrenergic agonist, is under investigation for the treatment of overactive bladder with symptoms of frequent urination, sudden urge to urinate, and urge incontinence or leakage. Urovant plans to file a New Drug Application (NDA) with the Food and Drug Administration (FDA) by early next year.