Vibegron, an oral small molecule beta-3 agonist currently under FDA review for overactive bladder (OAB) treatment, provides favorable efficacy and safety over 52 weeks, researchers announced during the American Urological Association 2020 Virtual Experience.

In a 40-week extension of the 12-week phase 3 EMPOWUR trial, 273 patients with OAB (78.2% wet OAB; 46.5% older than 65 years; 78.2% women) received vibegron (75 mg once daily) and 232 patients received tolterodine (extended-release 4 mg once daily). By 52 weeks, vibegron recipients had experienced more improvement in micturitions (-2.2 vs -1.7 per 24 hours, respectively), urgency (-3.4 vs -3.2 per 24 hours, respectively), and total urinary incontinence episodes (-2.5 vs -1.9 per 24 hours, respectively) than tolterodine recipients. In addition, 61% of vibegron recipients had a 75% or greater reduction in urge urinary incontinence, and 41% were completely dry, David Staskin, MD, of Tufts University School of Medicine in Boston, and colleagues reported.

Over the study period, 62.6% of vibegron and 54.3% of tolterodine recipients experienced adverse events. More than 5% of patients in each group had hypertension (8.8% vs 8.6%, respectively), urinary tract infection (6.6% vs 7.3%, respectively), and headache (5.5% vs 3.9%, respectively). A total of 1.5% of vibegron and 3.4% of tolterodine users discontinued the study drug due to AEs. One vibegron recipient died from arteriosclerotic disease, and the death was not deemed to be related to the medication.

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“Based upon the EMPOWUR studies, treatment with vibegron 75 mg once daily for 12 weeks was generally safe and efficacious in patients with urinary urgency with or without incontinence,” Dr Staskin told Renal & Urology News. “Vibegron does not inhibit the CYP2D6 pathway, thereby avoiding drug-drug interactions. Its sustained efficacy, absence of anticholinergic side-effects, and favorable safety profile—especially in elderly patients—were observed in both studies. If approved by the FDA, vibegron may be an important pharmacological agent in the treatment of OAB.”

“The double-blind extension of the EMPOWUR study provides further compelling data that vibegron has the potential to provide long-term benefits for people suffering with overactive bladder,” Cornelia Haag-Molkenteller, Chief Medical Officer at Urovant Sciences, which is developing vibegron, commented in a related news release. “These data increase our confidence in the vibegron OAB development program and we believe vibegron has the potential, if approved by the FDA, to become an exciting next-generation treatment option for patients suffering from OAB.”

Disclosure: This clinical trial was supported by Urovant Sciences, the developers of vibegron. Please see the original reference for a full list of authors’ disclosures.

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Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd P. 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). Presented at the American Urological Association 2020 Virtual Experience, May 15-19, 2020. Abstract PD21-01.

Urovant Sciences reports positive long-term data from the double-blind extension of the phase 3 EMPOWUR Study of vibegron in patients with overactive bladder [news release]. Urovant Sciences; September 24, 2019.