Urovant Sciences announced the publication of a new, post-hoc analysis of data from the Phase 3 EMPOWUR trial of GEMTESA (vibegron) 75 mg in the International Journal of Clinical Practice. The peer-reviewed paper is entitled, ”Vibegron for the Treatment of Patients with Dry and Wet Overactive Bladder: A Subgroup Analysis from the EMPOWUR Trial.“ The article is available online and will be published in an upcoming print issue of the journal. OAB is characterized by urgency and frequency with (OAB wet) or without (OAB dry) urge urinary incontinence (UUI).

Although OAB dry affects a larger proportion of the OAB population, studies of pharmacologic treatment typically report results in the overall OAB population or in patients with OAB wet. They also commonly focus on UUI as the most bothersome symptom of OAB. As a result, treatment guidelines do not differentiate between these patients and often neglect to address the need to manage the disruptive and core symptom of urgency associated with OAB.

The post-hoc analysis was developed to compare efficacy of vibegron vs. placebo in OAB wet and dry populations. These findings are consistent with overall EMPOWUR data showing favorable long-term safety, tolerability and efficacy in patients with overactive bladder; these were published in the Journal of Urology in May 2021.

In the EMPOWUR study, patients were randomly assigned 5:5:4 to receive once-daily vibegron 75 mg, placebo, or tolterodine 4 mg extended release, respectively, for 12 weeks. Serious adverse events associated with vibegron occurred at rates comparable with placebo (1.5 vs 1.1% for vibegron vs. placebo, respectively) in EMPOWUR; the most frequently occurring treatment-emergent adverse events (TEAEs) with incidence greater for vibegron than placebo were headache and nasopharyngitis.

Hypertension incidence was similar between vibegron and placebo treatment groups. About the EMPOWUR Trial: The EMPOWUR trial was an international, randomized, double-blind, placebo and active comparator-controlled Phase 3 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.