Urovant Sciences® Presents New Data from EMPOWUR Study, Advancing Knowledge of the Treatment of Overactive Bladder at the 2022 American Urological Association Meeting

  • New analyses of data from the Phase 3 EMPOWUR Extension Study of GEMTESA® (vibegron) 75 mg provided additional insight into the long-term effects of the product. These data were featured in podium presentations PD38-11 and PD38-12:
    • In a subgroup analysis of adults, 65 years old or above with overactive bladder, treatment with GEMTESA was safe and well tolerated. Treatment with GEMTESA was associated with sustained reductions from baseline in average daily micturition, urge urinary incontinence (UUI) episodes and urgency episodes. These results were consistent with the overall EMPOWUR study population (PD38-11).
    • GEMTESA at 52 weeks was associated with sustained and patient-perceived meaningful improvements in both the OAB questionnaire (OAB-q) and Patient Global Impression (PGI) scores in the EMPOWUR extension trial (PD38-12).
Reno, Nevada (UroToday.com) -- Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., announced new analyses from the Phase 3 EMPOWUR Extension Study of GEMTESA, presented Sunday at the 2022 annual meeting of the American Urological Association (AUA2022). The meeting is being held in New Orleans from May 13-16, 2022.

“The additional analyses of data on our overactive bladder therapy, GEMTESA, further confirm this drug’s potential utility and durability in this patient population”
“The additional analyses of data on our overactive bladder therapy, GEMTESA, further confirm this drug’s potential utility and durability in this patient population,” said Sef Kurstjens, MD, PhD, Executive Vice President and Chief Medical Officer of Urovant Sciences. “This is an additional demonstration of Urovant’s commitment to providing effective therapies for patients with urologic conditions.”

Two podium presentations at AUA2022 on May 15 featured new analyses of data from the EMPOWUR 40-week extension trial of GEMTESA (vibegron) 75 mg. This was a Phase 3, randomized, double-blind, active-comparator controlled, parallel-group multicenter study to evaluate long-term safety and efficacy in patients with symptoms of OAB. GEMTESA is approved by the U.S. Food and Drug Administration for the treatment of OAB symptoms of UUI, urgency, and urinary frequency in adults.

The first podium presentation, PD38-11, presented at 8:40-8:50 a.m. by Jeffrey Frankel, MD, Medical Director, Seattle Urology Research Center, Seattle, Washington, is titled, “Long-Term Efficacy and Safety of Vibegron for Overactive Bladder in Patients ≥65 Years Old: Analysis from the EMPOWUR Extension Trial.” In a subgroup analysis of adults, 65 years old or above with overactive bladder, treatment with GEMTESA was safe and well tolerated. Treatment with GEMTESA was associated with sustained reductions from baseline in average daily micturition, UUI episodes, and urgency episodes. These results were consistent with the overall EMPOWUR Extension Study population.

The second podium presentation, PD38-12, presented at 8:50-9:00 a.m. by David Staskin, MD, Associate Professor of Urology, Tufts University School of Medicine, is titled, “Long-Term Patient-Reported Outcomes of Vibegron for Overactive Bladder: Analyses from the EMPOWUR Extension Trial.” This analysis of data from the EMPOWUR Extension Trial supports that patient-perceived meaningful improvements in OAB questionnaire (OAB-q) and Patient Global Impression (PGI) scores were consistent with GEMTESA’s improvements in OAB symptoms and a favorable safety and tolerability profile during the 52-week treatment period.

Source: WIRE, BUSINESS. 2022. "Urovant Sciences® Presents New Data From EMPOWUR Study, Advancing Knowledge Of The Treatment Of Overactive Bladder At The 2022 American Urological Association Meeting". Businesswire.Com.
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