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GEMTESA SIGNIFICANTLY REDUCED
ALL 3 KEY OVERACTIVE BLADDER
SYMPTOMS* AT 12 WEEKS1-3

At 12 weeks, GEMTESA (vibegron) demonstrated significant reductions in average daily UUI episodes1,2†

Urge urinary incontinence (UUI)1,2

Graph showing reductions in urge urinary incontinence (UUI). Patients taking GEMTESA® had significant reductions in average daily UUI episodes at 12 weeks.

At 12 weeks, GEMTESA (vibegron) demonstrated significant reductions in average daily UUI episodes1,2†

LEAST SQUARE (LS) MEAN CHANGE FROM BASELINE
Week24812
Placebo (n=405)-0.8-1.0-1.2-1.4
GEMTESA 75mg (n=403)-1.4-1.7-1.8-2.0

~60% LS mean reduction from baseline in UUI episodes at 12 weeks vs 40% with placebo (2.0 vs 1.4, respectively)1

*The 3 key symptoms of OAB are urgency, micturition frequency, and UUI/leakage.3

Statistically significant improvement in UUI in the GEMTESA group vs placebo at Week 12 (P<0.0001).1,2,4

At 12 weeks, GEMTESA demonstrated significant reductions in average daily micturition frequency1,4*

Please see 12-week study design above.

Micturition frequency1,2

Graph showing reductions in average daily micturition frequency at 12 weeks. Patients taking GEMTESA® had significant improvements in micturition frequency.

Values

LS MEAN CHANGE FROM BASELINE
Week24812
Placebo (n=520)-0.5-0.7-1.0-1.3
GEMTESA 75mg (n=526)-0.9-1.2-1.6-1.8

Patients taking GEMTESA had a ~16% LS mean change from baseline in micturition frequency vs ~11% with placebo (-1.8 vs -1.3, respectively)1

*Statistically significant improvement in micturition frequency in the GEMTESA group vs placebo at Week 12 (P<0.001).1,4

At 12 weeks, GEMTESA demonstrated significant reductions in average daily urgency episodes1,4*

Please see 12-week study design above.

Urgency episodes1,2

Graph showing reductions in average daily urgency episodes. GEMTESA® features urgency reduction data in its label.

Values

LS MEAN CHANGE FROM BASELINE
Week24812
Placebo (n=520)-0.9-1.1-1.6-2.0
GEMTESA 75mg (n=526)-1.5-1.9-2.4-2.7

~43% of all OAB patients taking GEMTESA had a 50% reduction in urgency episodes vs placebo (~38%)2†

*P=0.002 vs placebo.1,2

Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.2

At 12 weeks, 52.4% of patients taking GEMTESA experienced a 75% reduction in daily UUI episodes vs 36.8% of patients on placebo2*

Please see 12-week study design above.

≥75% reduction in daily UUI episodes2

Graph showing achievement of ≥75% reduction in daily urge urinary incontinence (UUI) episodes. 52% of GEMTESA® patients vs ~37% of placebo patients.

Values

% OF PATIENTS ACHIEVING ≥75% REDUCTION IN UUI
 12 Weeks
Placebo (n=405)36.8%
GEMTESA 75mg (n=403)52.4%

*Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.2

GEMTESA is the first and only beta-3agonist with urgency reduction data inits label1

  • Urgency is the hallmark OAB symptom5,6
  • ~60% of individuals with OAB symptoms have urgency episodes without leakage7
Want to know what happened after Week 12?
Did you know there is a post hoc older adult subpopulation analysis for GEMTESA?
 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product.

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.

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product.

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.

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. GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2023. 2. Data on file. Sumitomo Pharma America, Inc. 3. 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 4. 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 5. Zhou F, Newman DK, Palmer MH. Urinary urgency in working women: what factors are associated with urinary urgency progression? J Womens Health. 2018;27(5):575-583. doi:10.1089/jwh.2017.6555 6. Salvatore S, Espuña-Pons M, Tubaro A. Urinary urgency: a symptom in need of a cure. Res Rep Urol. 2019;11:327-331. doi:10.2147/RRU.S216757 7. Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003;20(6):327-336. doi:10.1007/s00345-002-0301-4

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

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