Urovant Sciences Announces Publication of Phase 3 EMPOWUR Trial Results in the Journal of Urology
The double-blind, placebo-controlled 12-week trial, in patients with OAB, studied vibegron 75 mg once-daily compared to placebo and included an active control. In the trial, vibegron achieved rapid onset of action at two weeks in both co-primary endpoints and daily urgency episodes and statistically significant efficacy was maintained at all timepoints measured through the end of the study. Vibegron also achieved statistical significance over placebo on all 7 key secondary endpoints, including the most important secondary endpoint of reduction in urgency episodes. Vibegron demonstrated consistent efficacy, a favorable safety profile, and was well tolerated. The frequency of serious adverse events was similar across treatment arms and the incidence of the reported adverse event of hypertension for vibegron was equal to placebo. The New Drug Application (NDA) seeking approval of once-daily 75 mg vibegron for the treatment of patients with overactive bladder (OAB) was submitted to the
“Over 30 million people in the
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.
The full publication can be accessed online here.
Vibegron is a once-daily, beta-3 adrenergic agonist under investigation for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Sumitovant is a global biopharmaceutical company with offices in
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief or expectations and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding Urovant’s plans to advance the clinical development of vibegron in patients with OAB. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Urovant’s development activities, including the timing of the initiation and completion of clinical trials and the timing of expected regulatory filings; the clinical utility and potential attributes and benefits of vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; our intellectual property position, including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs; and other risks and uncertainties listed in the Company’s filings with the