GEMTESA SIGNIFICANTLY REDUCED
ALL 3 KEY OVERACTIVE BLADDER
SYMPTOMS* AT 12 WEEKS^1-3

At 12 weeks, GEMTESA (vibegron) demonstrated significant reductions in average daily UUI episodes^1,2†

~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

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. — Values

LEAST SQUARE (LS) MEAN CHANGE FROM BASELINE

Week 2 4 8 12

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 frequency^1,4*

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

Please see 12-week study design above.

Micturition frequency^1,2

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

Week 2 4 8 12

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 episodes^1,4*

~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

Please see 12-week study design above.

Urgency episodes^1,2

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

LS MEAN CHANGE FROM BASELINE

Week 2 4 8 12

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*

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

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-3 agonist with urgency reduction data in its label¹

Urgency is the hallmark OAB symptom^5,6
~60% of individuals with OAB symptoms have urgency episodes without leakage⁷

Want to know what happened after Week 12?

EXTENSION STUDY DATA

Did you know there is a post hoc older adult subpopulation analysis for GEMTESA?

Older adult subgroup analysis

12-week, double-blind treatment period

Studied in more than 1500 patients with overactive bladder^1,2

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

Values

2-week run-in period² 12-week, double-blind treatment period²

RANDOMIZATION

Placebo Placebo (n=540)

GEMTESA 75 mg (n=545)

Active control (n=430)

Week 0 Week 12

Diagram showing the structure of the GEMTESA® study. Over 1500 patients participated in the study. — Values

2-week run-in period² 12-week, double-blind treatment period²

RANDOMIZATION

Placebo Placebo (n=540)

GEMTESA 75 mg (n=545)

Active control (n=430)

Week 0 Week 12

GEMTESA met efficacy endpoints¹

Co-primary endpoints^1,2

CFB in average daily number of micturitions and urge urinary incontinence (UUI) episodes

Key secondary endpoints^1,2

CFB in average daily number of urgency episodes
Percent of OAB-wet patients at week 12 with ≥75% reduction in total number of UUI 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.

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

12-week patient demographics^1,2

YEARS OLD
MEAN AGE

85^%

FEMALE

15^%

MALE

77% OAB WET^†

23% OAB DRY^†

Treatment naïve or had prior ACh or beta-3 agonist use in 12 months before study

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^1‡

^†OAB wet=average of ≥1 UUI episode per day. OAB dry=average of ≥3 urgency episodes and average of <1 UUI episode per day.³

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

ACh=anticholinergic; CFB=change from baseline; FAS=full analysis set; FAS-I=full analysis set for incontinence.

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

2-week run-in period²	12-week, double-blind treatment period²
RANDOMIZATION
Placebo	Placebo (n=540)
	GEMTESA 75 mg (n=545)
	Active control (n=430)
Week 0	Week 12

LEAST SQUARE (LS) MEAN CHANGE FROM BASELINE
Week	2	4	8	12
Placebo (n=405)	-0.8	-1.0	-1.2	-1.4
GEMTESA 75mg (n=403)	-1.4	-1.7	-1.8	-2.0

LS MEAN CHANGE FROM BASELINE
Week	2	4	8	12
Placebo (n=520)	-0.5	-0.7	-1.0	-1.3
GEMTESA 75mg (n=526)	-0.9	-1.2	-1.6	-1.8

LS MEAN CHANGE FROM BASELINE
Week	2	4	8	12
Placebo (n=520)	-0.9	-1.1	-1.6	-2.0
GEMTESA 75mg (n=526)	-1.5	-1.9	-2.4	-2.7

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

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

Values

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

Micturition frequency1,2

Values

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

Urgency episodes1,2

Values

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

≥75% reduction in daily UUI episodes2

Values

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

Want to know what happened after Week 12?

Did you know there is a post hoc older adult subpopulation analysis for GEMTESA?

GEMTESA SIGNIFICANTLY REDUCED
ALL 3 KEY OVERACTIVE BLADDER
SYMPTOMS* AT 12 WEEKS^1-3

At 12 weeks, GEMTESA (vibegron) demonstrated significant reductions in average daily UUI episodes^1,2†

Urge urinary incontinence (UUI)^1,2

At 12 weeks, GEMTESA demonstrated significant reductions in average daily micturition frequency^1,4*

Micturition frequency^1,2

At 12 weeks, GEMTESA demonstrated significant reductions in average daily urgency episodes^1,4*

Urgency episodes^1,2

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

≥75% reduction in daily UUI episodes²

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