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Proven efficacy and an established safety profile for older adults1

GEMTESA was evaluated at 12 weeks and 52 weeks in the overall study population2-4

Change from baseline at 12 weeks and 52 weeks, Table

Efficacy analyses were performed using the FAS, except for incontinence episode endpoints, which used the FAS-EXT.3,5

*P<0.0001 vs placebo.2-4

†P<0.001 vs placebo.2-4

‡P=0.002 vs placebo.2-4

§ Data were based on an exploratory endpoint analysis of patients with 100% reduction in UUI from baseline at week 52 (n=143).4

In the older adult subpopulation, reductions in all 3 key OAB symptoms* were

Consistent with the overall study population at 12 weeks1

No overall differences in safety or effectiveness of GEMTESA have been observed between patients aged 65+ years and younger adult patients

This post hoc subpopulation analysis was not powered to detect differences within subgroups and is therefore limited by the small sample sizes, particularly in the subgroup of patients aged ≥75 years.

UUI
Frequency
Urgency

Mean daily reduction in UUI at 12 weeks in older adults1

Reduction in UUI at 12 weeks in older adults, Graph

Reduction in average daily UUI/leakage episodes at 12 weeks (co-primary endpoint) vs placebo.

* OAB symptoms include urgency, frequency, and UUI.6

† Patients 65+ baseline: 3.28 for GEMTESA; 3.33 for placebo.4

‡ Patients 75+ baseline: 3.54 for GEMTESA; 2.85 for placebo.4

§P<0.001 vs placebo as Week 12.1

GEMTESA IS THE FIRST AND ONLY β3-AGONIST WITH URGENCY REDUCTION DATA IN ITS LABEL2,6,7
Explore efficacy in the overall population

FAS=full analysis set; FAS-EXT=full analysis set extension; OAB=overactive bladder; UUI=urge urinary 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:

  1. Varano S, Staskin D, Frankel J, Shortino D, Jankowich R, Mudd PN Jr. Efficacy and safety of once-daily vibegron for treatment of overactive bladder in patients aged ≥65 and ≥75 years: subpopulation analysis from the EMPOWUR randomized, international, phase III study. Drugs Aging. 2021;38(2):137-146. doi:10.1007/s40266-020-00829-z
  2. GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2025.
  3. 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
  4. Data on file. Sumitomo Pharma America, Inc.
  5. 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
  6. 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
  7. Myrbetriq. Prescribing information. Astellas Pharma Inc; 2012. Revised 04/2021.

You are encouraged to report side effects and product complaints associated with GEMTESA by calling 1-833-876-8268.

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