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Always having to go can put a stop to whatever patients are doing¹

Up to 40% of people aged 40+ years have OAB symptoms²

Prevalence and severity increase
with age³

African Americans and Latinos are ~3-5 times more likely than white patients to be diagnosed with OAB⁴

Are your patients experiencing…

Frequency (8+ times per day) that disrupts their life?^3,5
Urge urinary incontinence or fear they may not make it to the bathroom in time?⁵
A frequent, sudden rush and urgency to go?⁵

Many men are struggling with OAB symptoms in silence^6-8

OAB and BPH prevalence increase with age^1,9

OAB symptoms impact

~3in10

men aged ≥60 years¹⁰

As many as

3in4

men with BPH also have OAB symptoms^11-13

However, there is a significant gap in OAB treatment for male patients¹¹

4in5

men with OAB may remain undiagnosed⁹

Is it BPH or OAB? Many symptoms of OAB are overshadowed by BPH¹¹

Enduring both OAB and BPH can be confusing for patients. They may not be able to attribute which condition is causing their burdensome symptoms.¹¹

This is not an exhaustive list of all OAB symptoms. GEMTESA is only indicated to treat the 3 key symptoms of OAB.¹⁴* Treat OAB and BPH independently.

OAB and BPH can both cause urgency, frequency, and incontinence

OAB and BPH can both cause urgency, frequency, and incontinence

GEMTESA® 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.
overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

WARNINGS AND PRECAUTIONS

Urinary Retention

Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

Angioedema

Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

INDICATIONS AND USAGE

GEMTESA® 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.
overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

WARNINGS AND PRECAUTIONS

Urinary Retention

Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

Angioedema

Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

Please see full Prescribing Information.

References:

Willis-Gray MG, Dieter AA, Geller EJ. Evaluation and management of overactive bladder: strategies for optimizing care. Res Rep Urol. 2016;8:113-122. doi:10.2147/RRU.S93636
Yang CF, Huang CY, Wang SY, Chang SR. Prevalence of and associated factors for overactive bladder subtypes in middle-aged women: a cross-sectional study. Medicina (Kaunas). 2022;58(3):383. doi:10.3390/medicina58030383
Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder. J Urol. Published online April 23, 2024. doi:10.1097/JU.0000000000003985. https://www.auajournals.org/doi/10.1097/JU.0000000000003985
Coyne KS, Sexton CC, Bell JA, et al. The prevalence of lower urinary tract symptoms (LUTS) and overactive bladder (OAB) by racial/ethnic group and age: results from OAB-POLL. Neurourol Urodyn. 2013;32(3):230-237. doi:10.1002/nau.22295
Homma Y, Kakizaki H, Yamaguchi O, et al. Assessment of overactive bladder symptoms: comparison of 3-day bladder diary and the overactive bladder symptoms score. Urology. 2011;77(1):60-64. doi:10.1016/j.urology.2010.06.044
Rosen R, Altwein J, Boyle P, et al. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol. 2003;44(6):637-649. doi:10.1016/j.eururo.2003.08.015
Foster P, Luebke M, Razzak AN, et al. Stigmatization as a barrier to urologic care: a review. Health Psychol Res. 2023;11:84273. doi:10.52965/001c.84273
Egan KB. The epidemiology of benign prostatic hyperplasia associated with lower urinary tract symptoms: prevalence and incident rates. Urol Clin North Am. 2016;43(3):289-297. doi:10.1016/j.ucl.2016.04.001
Anger JT, Goldman HB, Luo X, et al. Patterns of medical management of overactive bladder (OAB) and benign prostatic hyperplasia (BPH) in the United States. Neurourol Urodyn. 2018;37(1):213-222. doi:10.1002/nau.23276
Cheng Y, Chen T, Zheng G, et al. Prevalence and trends in overactive bladder among men in the United States, 2005–2020. Sci Rep. 2024;14(1):16284. doi:10.1038/s41598-024-66758-8
Burnett AL, Walker OR, Feng Q, et al. Undertreatment of overactive bladder among men with lower urinary tract symptoms in the United States: a retrospective observational study. Neurourol Urodyn. 2020;39(5):1378-1386. doi:10.1002/nau.24348
Chapple C. Systematic review of therapy for men with overactive bladder. Can Urol Assoc J. 2011;5(5 suppl 2):S143-S145. doi:10.5489/cuaj.11186
Gomelsky A, Omochowski RR. Overactive bladder in males. Ther Adv Urol. 2009;1(4):209-221. doi:10.1177/1756287209350383
GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2025.
D'Ancona C, Haylen B, Oelke M, et al, and the Standardisation Steering Committee ICS and the ICS Working Group on Terminology for Male Lower Urinary Tract and Pelvic Floor Symptoms and Dysfunction. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019;38(2):433-477. doi:10.1002/nau.23897
Millman AL. Cheung DC, Hackett C, Elterman D. Overactive bladder in men: a practical approach. Br J Gen Pract. 2018;68(671):298-299. doi:10.3399/bjgp18X695693
Edmondson SD, Zhu C, Kar NF, et al. Discovery of vibegron: a potent and selective 3 adrenergic receptor agonist for the treatment of overactive bladder. J Med Chem. 2016;59(2):609-623. doi:10.1021/acs.jmedchem.5b01372.

STUDIED IN MORE THAN 1500 PATIENTS WITH OAB^1,2

12-week double-blind treatment period²

12 week double blind treatment period, Diagram

12 week double blind treatment period, Diagram

50.6% OF PATIENTS ENROLLED HAD HYPERTENSION AT BASELINE³

A 12-week, Phase 3, randomized, double-blind, placebo- and active-controlled multicenter study to evaluate the safety and efficacy of GEMTESA in 1500+ patients with symptoms of OAB.^1,2

12-week patient demographics^1-3

60

Years Old
Mean Age

Female

FEMALE

85%

FEMALE

MALE

15%

male

MALE

Treatment naïve or had prior ACh or β₃-agonist use in 12 months before study

77% OAB WET*

23% OAB DRY*

Symptoms of OAB ≥3 months with average ≥8 micturitions/day and ≥1 UUI/day, or average ≥8 micturitions/day and average ≥3 urgency episodes/day^2†

* OAB wet=average of ≥1 urge urinary incontinence episode per day; OAB dry=average of ≥3 urgency episodes and average of <1 urge urinary incontinence episode per day.²

^† UUI was defined as leakage of urine of any amount because the patient felt an urge or need to urinate immediately.¹

GEMTESA met efficacy endpoints^1,2

12-week study efficacy endpoints

Co-primary endpoints

CFB in average daily number of micturitions and urge urinary incontinence episodes at Week 12

Key secondary endpoints

CFB in average daily number of urgency episodes at Week 12
Percent of OAB-wet patients at Week 12 with ≥75% reduction in total number of urge urinary incontinence episodes in 24 hours*
Percent of all OAB patients at Week 12 with 50% reduction in total number of urgency episodes per 24 hours*

Efficacy analyses were performed using the FAS, except for incontinence episode endpoints, which used the FAS-I.²

* Data were based on unadjusted values for a supportive outcome measure that was a prescribed secondary endpoint in the pivotal EMPOWUR trial.²
ACh=anticholinergic; CFB=change from baseline; FAS=full analysis set; FAS-I=full analysis set for incontinence; OAB=overactive bladder; UUI=urge urinary incontinence.

References:

GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2025.
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
Data on file. Sumitomo Pharma America, Inc.