Urovant Sciences® Presents New Data from the EMPOWUR Study, Advancing Knowledge in the Treatment of Overactive Bladder at the 2022 American Urological Association Meeting
IRVINE, Calif. and BASEL, Switzerland–(BUSINESS WIRE)–Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., announced new analyzes from GEMTESA’s EMPOWUR Phase 3 extension study, presented Sunday at the 2022 American Urological Annual Meeting Association (AUA2022). The meeting will be held in New Orleans from May 13-16, 2022.
“Additional analyzes of data on our treatment for overactive bladder, GEMTESA, further confirm the potential utility and durability of this drug in this patient population,” said Sef Kurstjens, MD, PhD, executive vice president and director Medical from Urovant Sciences. “This is further demonstration of Urovant’s commitment to providing effective therapies for patients with urological disorders.
Two podium presentations at AUA2022 on May 15 featured new analyzes of data from the EMPOWUR 40-week extension trial of GEMTESA (vibegron) 75 mg. This was a Phase 3, multicenter, randomized, double-blind, active comparator-controlled, parallel-group study to assess the long-term safety and efficacy in patients with symptoms of overactive bladder . GEMTESA is approved by the United States 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 from 8:40 a.m. to 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 Bladder hyperactive in patients aged ≥ 65 years: analysis of the EMPOWUR extension trial. In a subgroup analysis of adults 65 years of age or older with overactive bladder, treatment with GEMTESA was safe and well tolerated. GEMTESA treatment was associated with sustained reductions from baseline in mean daily urination, UUI episodes, and urgency episodes. These results were consistent with the overall population of the EMPOWUR extension study.
The second podium presentation, PD38-12, presented from 8:50 a.m. to 9:00 a.m. by David Staskin, MD, associate professor of urology, Tufts University School of Medicine, is titled “Patient-Reported Long-Term Outcomes of Vibegron for Overactive Bladder: Analyzes from the EMPOWUR Expansion Trial. This analysis of data from the EMPOWUR extension trial confirms that significant patient-perceived improvements in OAB Questionnaire (OAB-q) and Patient Global Impression (PGI) scores were consistent with improvements in GEMTESA of OAB symptoms and a favorable safety and tolerability profile over the 52-week treatment period.
Summaries are available in the Journal of Urology at the following links:
Elderly people EMPOWUR-EXT: https://www.auajournals.org/doi/10.1097/JU.0000000000002596.11
EMPOWUR-EXT PRO: https://www.auajournals.org/doi/10.1097/JU.0000000000002596.12
About the EMPOWUR Trial
The EMPOWUR trial was an international, Phase 3, randomized, double-blind, placebo-controlled, active-comparator clinical trial evaluating the safety and efficacy of investigational vibegron in men and women with symptoms of overactive bladder, including frequent urination, urgency and UUI. . A total of 1,518 patients were randomized across 215 study sites to one of three groups for a 12-week treatment period with a four-week safety follow-up period: vibegron 75 mg administered orally once per day ; placebo administered orally once daily; or tolterodine ER 4 mg taken orally once daily.
About the EMPOWUR 40 week extension
The EMPOWUR 40-week extension trial was a Phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the long-term safety and efficacy of vibegron in patients with symptoms of overactive bladder. The extension study recruited approximately 500 EMPOWUR graduates. The primary endpoint was safety, measured by the incidence of adverse events. Secondary endpoints were changes from EMPOWUR baseline at week 52 in mean daily voiding, UUI, urgency, and total urinary incontinence.
About Overactive Bladder
Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urge incontinence (involuntary loss of urine immediately after an urgent need to urinate), frequent urination (usually eight times or more in 24 hours) and nocturia (waking up more than twice in the night to urinate).1
Approximately 30 million Americans suffer from bothersome symptoms of an overactive bladder, which can significantly impair a patient’s daily activities.1, 2
GEMTESA is a prescription medicine for adults used to treat the following symptoms of a condition called overactive bladder:
urge urinary incontinence: a strong need to urinate with leaks or pee accidents
urgency: the need to urinate right away
frequency: urinating often
It is not known if GEMTESA is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.
Before taking GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have difficulty emptying your bladder or your urine stream is weak; taking medications containing digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; tell your doctor if you are pregnant or plan to become pregnant); you are breast-feeding or planning to breast-feed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you are taking GEMTESA).
Tell your doctor about all the medicines you are taking, including prescription and over-the-counter medications, vitamins, and herbal supplements. Know the medications you take. Keep a list to show your doctor and pharmacist when you get a new medicine.
What are the possible side effects of GEMTESA?
GEMTESA can cause serious side effects, including the inability to empty your bladder (urinary retention). GEMTESA may increase your risk of not being able to empty your bladder, particularly if you have a bladder outlet obstruction or are taking other medicines for the treatment of overactive bladder. Tell your doctor immediately if you are unable to empty your bladder.
The most common side effects of GEMTESA include headache, urinary tract infections, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infections. These are not all the possible side effects of GEMTESA. For more information, consult your doctor or pharmacist.
Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.
Please Click here for complete product information for GEMTESA.
About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies for areas of unmet need, with a particular focus on urology. The company’s flagship product, GEMTESA®(vibegron), is a small molecule beta-3 agonist taken orally once daily (75 mg) for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, d urgency and urinary frequency. GEMTESA was approved by the US FDA in December 2020 and launched in the US in April 2021. GEMTESA is also being evaluated for the treatment of overactive bladder in men with benign prostatic hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy in development for patients with overactive bladder who have failed oral pharmacological therapy. Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., intends to bring innovation to patients in need in urology and other areas of unmet need. Learn more about us at www.urovant.com or follow us on Twitter or LinkedIn.
About Sumitovent Biopharma
Sumitovant is a global biopharmaceutical company that leverages data-driven insights to rapidly accelerate the development of potential new therapies for unmet patient conditions. Through our unique portfolio of wholly-owned “Vant” subsidiaries – Urovant, Enzyvant, Spirovant, Altavant – and the use of embedded computing technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline. from early to late stage investigational assets for other serious conditions. Sumitovant, a wholly owned subsidiary of Sumitomo Pharma, is also the majority shareholder of Myovant (NYSE: MYOV). For more information, please visit our website at www.sumitovan.com.
Reynolds, WS, Fowke, J. & Dmochowski, R. (2016). The Burden of Overactive Bladder on American Public Health. Current reports of bladder dysfunction, 11(1), 8–13. https://doi.org/10.1007/s11884-016-0344-9
Coyne, KS, Sexton, CC, Vats, V., Thompson, C., Kopp, ZS and Milsom, I. (2011). National community prevalence of overactive bladder in the United States stratified by sex and age. Urology, 77(5), 1081–1087.
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