For your patients with overactive bladder (OAB)
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GEMTESA® (vibegron) is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
There's more to know about GEMTESA, a beta-3 agonist
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Prescribe GEMTESA 1st* for OAB symptom relief
PROVEN
EFFICACY DATA
- Statistically significant reduction of all 3 key OAB symptoms† vs placebo at
12 weeks—including urgency1,2‡ - First and only beta-3 agonist with proven urgency reduction data in its label1,2
First and only
BETA-3 agonist with
one dose, no titration
- Once-daily 75-mg dose with no titration, to be taken with or without food and swallowed whole with a glass of water1
- Crushability. In adults, GEMTESA tablets may be crushed, mixed with a tablespoon (~15 mL) of applesauce and taken immediately with a glass of water1
First and only
BETA-3 agonist with
NO BLOOD PRESSURE
WARNING IN ITS LABEL1
- No association with clinically significant changes to hypertension or increased blood pressure vs placebo3§||
Additional efficacy data
- ~43% of all OAB patients taking GEMTESA had a 50% reduction in urgency episodes at Week 12 vs 38% with placebo4¶
- 52.4% of patients taking GEMTESA had a ≥75% reduction in urge urinary incontinence (UUI) episodes at Week 12 vs 36.8% with placebo4¶
- 100% reduction in UUI episodes was reported at 12 weeks (28.8% of patients taking GEMTESA vs 22.5% with placebo) and 52 weeks (40.8% of patients taking GEMTESA vs 34.2% with active control)4,5#
¶Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.4
#Data were based on a prespecified secondary efficacy endpoint analysis of patients with 100% reduction in UUI from baseline at Week 12 (n=403) and an exploratory endpoint analysis of patients with 100% reduction in UUI from baseline at Week 52 (n=143).4
*First pharmacologic medication after behavioral therapy.6
†The 3 key symptoms of OAB are urgency, micturition frequency, and UUI/leakage.2
‡The efficacy of GEMTESA was evaluated in a pivotal 12-week, double-blind, randomized, placebo- and active-controlled trial in patients with OAB (UUI, urgency, and urinary frequency). For study entry, patients had to have symptoms of OAB for at least 3 months with an average of 8 or more micturitions per day and at least 1 UUI per day, or an average of 8 or more micturitions per day and an average of at least 3 urgency episodes per day. A total of 1515 patients received at least 1 daily dose of placebo (n=540), GEMTESA 75 mg (n=545), or an active-control treatment (n=430). The majority of patients were Caucasian (78%) and female (85%) with a mean age of 60 (range 18 to 93) years.1,4
§In a 12-week pivotal study, hypertension rates for OAB patients taking GEMTESA (n=545) were 1.7% vs 1.7% with placebo (n=540). Increased blood pressure (BP) rates were 0.7% with GEMTESA vs 0.9% with placebo.7
||In a 4-week, randomized, placebo-controlled, ambulatory BP study in OAB patients (n=200), GEMTESA 75 mg was not associated with clinically significant changes in BP. Mean age 59 years; 75% female. At baseline: 35% of subjects had preexisting hypertension; 29% were taking at least 1 concomitant antihypertensive medication.1
Clinically significant reductions in all 3 key OAB symptoms* vs placebo at 12 weeks1,2†:
*The 3 key symptoms of OAB are urgency, micturition frequency, and UUI/leakage.2
†The efficacy of GEMTESA was evaluated in a pivotal 12-week, double-blind, randomized, placebo- and active-controlled trial in patients with OAB (UUI, urgency, and urinary frequency). For study entry, patients had to have symptoms of OAB for at least 3 months with an average of 8 or more micturitions per day and at least 1 UUI per day, or an average of 8 or more micturitions per day and an average of at least 3 urgency episodes per day. A total of 1515 patients received at least 1 daily dose of placebo (n=540), GEMTESA 75 mg (n=545), or an active-control treatment (n=430). The majority of patients were Caucasian (78%) and female (85%) with a mean age of 60 (range 18 to 93) years.1
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References: 1. GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2023. 2. Edmondson SD, Zhu C, Kar NF, et al. Discovery of vibegron: a potent and selective β3 adrenergic receptor agonist for the treatment of overactive bladder. J Med Chem. 2016;59(2):609-623. doi:10.1021/acs.jmedchem.5b01372 3. Weber MA, Haag-Molkenteller C, King J, Walker A, Mudd PN, White WB. Effects of vibegron on ambulatory blood pressure in patients with overactive bladder: results from a double-blind, placebo-controlled trial. Blood Press Monit. 2022;27:128-134. 4. Data on file. Sumitomo Pharma America, Inc. 5. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. Once-daily vibegron 75 mg for overactive bladder: long-term safety and efficacy from a double-blind extension study of the international phase 3 trial (EMPOWUR). J Urol. 2021;205(5):1421-1429. doi:10.1097/JU.0000000000001574 6. Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. American Urological Association/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction; 2019. Accessed July 20, 2021. https://www.auanet.org//guidelines-and-quality/guidelines/overactive-bladder-(oab)-guideline 7. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. International phase III, randomized, double-blind, placebo and active controlled study to evaluate the safety and efficacy of vibegron in patients with symptoms of overactive bladder: EMPOWUR. J Urol. 2020;204(2):316-324. doi:10.1097/JU.0000000000000807