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OAB DOESN’T LOOK THE
SAME IN EVERY PATIENT

OAB symptoms* have more impact on patients' lives than you may think. These are examples of patients with different clinical histories and OAB presentation who might benefit from taking GEMTESA.^1,2

Choose a characteristic of OAB that you see in your practice:

Is BPH Treatment Enough?

He has been taking his BPH medication for a while, but persistent urinary symptoms like urgency are disrupting his life.

Meet Carl^†

Embarrassing Urgency

He tried other treatments, but he still feels like he's always running to the bathroom. He just wants to spend more time with his grandchildren.

Meet Robert^†

Frequency on the Job

She wants to focus on teaching — not bathroom breaks — but she's concerned about OAB treatment interfering with her other medications.

Meet Ann^†

Urgency Limiting Daily Life

She has hypertension and is concerned about drug interactions. She wants to go out without worrying about finding the closest bathroom.

Meet Laura^†

Escalating Urge Urinary Incontinence

She is experiencing frequent UTIs and struggles coping with OAB.

Meet Allison^†

Disruptive Frequency

As a 47-year-old working mom, her life is significantly disrupted by OAB symptoms.

Meet Carolina^†

*OAB symptoms include urgency, frequency, and UUI.⁹

^†Not an actual patient.

BPH=benign prostatic hyperplasia; OAB=overactive bladder; UTI=urinary tract infection.

See if your patients could benefit from GEMTESA

See patients 75+

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:

GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2025.
Data on file. Sumitomo Pharma America, Inc.
Hansten PD, Horn JR. The Top 100 Drug Interactions; A Guide to Patient Management. 2019 ed. Freeland, WA: H&H Publications, LLP; 2019.
Kobriger A. Drug Use in Long-Term Care (Effects on Nutrition & Health Status). OnCourse Learning; 2011:i-170.
Crestor. Prescribing information. AstraZeneca; 2024.
Oxybutynin (Oral Route): side effects. Mayo Foundation for Medical Education and Research. Updated March 1, 2023. Accessed March 15, 2024. https://www.mayoclinic.org/drugs-supplements/oxybutynin-oral-route/side-effects/drg-20065229?p=1
Meeks TW, Culberson JW, Horton MS. Medications in long-term care: when less is more. Clin Geriatr Med. 2011;27(2):171-191. doi:10.1016/j.cger.2011.01.003
Myrbetriq. Prescribing information. Astellas Pharma Inc; 2012. Revised 04/2021.
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

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.