The GEMTESA pivotal study had more than 1500 patients with OAB and the extension study had over 500 patients¹

GEMTESA (vibegron) was studied in a phase 3, randomized, double-blind, placebo- and active-controlled multicenter study^2,3

At Week 12, safety and efficacy were evaluated in over 1500 patients with symptoms of overactive bladder (OAB)^2,3
- GEMTESA demonstrated a statistically significant reduction of all 3 key OAB symptoms* vs placebo at 12 weeks—including urgency^2,4†
- ~43% of all OAB patients taking GEMTESA had a 50% reduction in urgency episodes at Week 12 vs 38% with placebo^3‡
505 patients continued on to a 40-week, phase 3, randomized, double-blind, active-controlled, multicenter extension study that evaluated the safety and efficacy of GEMTESA^1§

*The 3 key symptoms of OAB are urgency, micturition frequency, and urge urinary incontinence (UUI).⁴

^†The efficacy of GEMTESA was evaluated in a 12-week, double-blind, randomized, placebo- and active-controlled trial in patients with OAB (UUI, urgency, and urinary frequency). For study entry, patients had to have symptoms of OAB for at least 3 months with an average of 8 or more micturitions per day and at least 1 UUI per day, or an average of 8 or more micturitions per day and an average of at least 3 urgency episodes per day. A total of 1515 patients received at least 1 daily dose of placebo (n=540), GEMTESA 75 mg (n=545), or an active-control treatment (n=430). The majority of patients were Caucasian (78%) and female (85%), with a mean age of 60 (range 18 to 93) years.^2,3

^‡Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.³

^§A limitation of this study is the potential for selection bias for patients who elected to enter the EMPOWUR extension.¹

Safety and efficacy of GEMTESA were evaluated at 52 weeks¹

Reductions in UUI per 24 hours at 52 weeks vs active control^1,3*

*Baseline: 3.18 for GEMTESA; 3.0 for active control.³

Urge urinary incontinence (UUI)^1,3*

Graph showing reductions in urge urinary incontinence (UUI) episodes. Reductions in UUI per 24 hours at 52 weeks with GEMTESA®. — Values

LS MEAN CHANGE FROM BASELINE

Week 12 16 24 44 52

Active control (n=106) -1.8 -1.8 -2.0 -1.7 -1.7

GEMTESA 75 mg (n=143) -1.9 -2.0 -2.1 -2.1 -2.2

*Baseline: 3.18 for GEMTESA; 3.0 for active control.³

Reductions in micturition frequency per 24 hours at 52 weeks vs active control¹*

*Baseline: 11.32 for GEMTESA; 11.33 for active control.³

Please see extension study design above.

Micturition frequency^1,3*

Graph showing reductions in micturition frequency. Micturition frequency at week 52 with GEMTESA®. — Values

LS MEAN CHANGE FROM BASELINE

Week 12 16 24 44 52

Active control (n=136) -1.5 -1.9 -1.9 -1.8 -2.0

GEMTESA 75 mg (n=176) -2.0 -2.2 -2.3 -2.5 -2.4

*Baseline: 11.32 for GEMTESA; 11.33 for active control.³

Reductions in urgency episodes
per 24 hours at 52 weeks vs
active control¹*

*Baseline: 8.0 for GEMTESA; 8.03 for active control.³

Please see extension study design above.

Urgency episodes^1,3*

Graph showing reductions in urgency episodes. Reductions in urgency episodes per 24 hours at 52 weeks with GEMTESA®. — Values

LS MEAN CHANGE FROM BASELINE

Week 12 16 24 44 52

Active control (n=136) -2.2 -3.0 -3.0 -3.2 -3.2

GEMTESA 75 mg (n=176) -3.0 -3.1 -3.3 -3.9 -3.4

*Baseline: 8.0 for GEMTESA; 8.03 for active control.³

Reductions in UUI episodes of 100% at 12 weeks and at 52 weeks vs placebo and active control, respectively^1,3*^†

*Data were based on a key secondary endpoint analysis of OAB-wet patients with 100% reduction in UUI from baseline at Week 12 (n=403).³

^†Data were based on an exploratory endpoint analysis of OAB-wet patients with 100% reduction in UUI from baseline at Week 52 (n=143).³

Please see extension study design above.

100% reduction in UUI episodes^1,3

Percentage of patients with 100% reduction in urge urinary incontinence (UUI) episodes with GEMTESA® vs placebo and active control. — Values

% OF PATIENTS WITH 100% REDUCTION IN UUI

12 Weeks 52 Weeks

Active control (n=403) 23%* (n=106) 34%†

GEMTESA 75 mg (n=405) 29%* (n=143) 41%†

*Data were based on a key secondary endpoint analysis of OAB-wet patients with 100% reduction in UUI from baseline at Week 12 (n=403).³

^†Data were based on an exploratory endpoint analysis of OAB-wet patients with 100% reduction in UUI from baseline at Week 52 (n=143).³

Want more details about the pivotal 12-week study?

PIVOTAL STUDY EFFICACY

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

Older adult subgroup ANALYSIS

More than 500 patients were studied
in the 40-week extension period¹

Study design description

A 12-week, phase 3, randomized, double-blind, placebo- and active-controlled, multicenter study evaluated the safety and efficacy of GEMTESA in 1500+ patients with symptoms of overactive bladder (OAB).^2,3

A 40-week, phase 3, randomized, double-blind, active-controlled, multicenter extension study evaluated the safety and efficacy of GEMTESA in 505 patients with symptoms of OAB.^1*

Values

40-WEEK, DOUBLE-BLIND EXTENSION PERIOD

2-week run-in period^2,3 12-week, double-blind treatment period^2,3 40-week, double-blind extension study¹

Randomization Placebo group rolled into an active teartment arm¹

Placebo Placebo (n=540)

Gemtesa 75 mg (n=545) Gemtesa 75 mg (n=273)

Active Control (n=430) Active Control (n=232)

Week 0 Week 12 Week 52

Diagram showing the structure of the GEMTESA® extension study. Over 500 patients participated in the extension study. — Values

40-WEEK, DOUBLE-BLIND EXTENSION PERIOD

2-week run-in period^2,3 12-week, double-blind treatment period^2,3 40-week, double-blind extension study¹

Randomization Placebo group rolled into an active teartment arm¹

Placebo Placebo (n=540)

Gemtesa 75 mg (n=545) Gemtesa 75 mg (n=273)

Active Control (n=430) Active Control (n=232)

Week 0 Week 12 Week 52

*A limitation of this study is the potential for selection bias for patients who elected to enter the EMPOWUR extension.¹

Study endpoints^1-3

	Efficacy at 12 weeks	Safety at 52 weeks
PRIMARY ENDPOINT
PRIMARY ENDPOINT	Change from baseline in average daily number of micturitions and urge urinary incontinence (UUI) episodes (wet OAB)	Incidence of treatment-emergent adverse events

	At 12 weeks (key secondary endpoint)	At 52 weeks
SECONDARY ENDPOINT
SECONDARY ENDPOINT	Change from baseline in average daily number of urgency episodes	Change from baseline at Week 52 in average daily number of: Micturitions UUI episodes (wet OAB) Urgency episodes

	At 12 weeks	At 52 weeks
100% REDUCTION IN UUI EPISODES
100% REDUCTION IN UUI EPISODES	Secondary endpoint	Exploratory endpoint

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

52-week patient demographics^1-3

YEARS OLD
MEAN AGE

78^%

FEMALE

22^%

MALE

78% OAB WET^†

22% OAB DRY^†

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

Inclusion criteria: 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 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.²

ACh=anticholinergic; FAS-EXT=full analysis set extension; FAS-EXT-I=full analysis set extension 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. 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 2. GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2023. 3. Data on file. Sumitomo Pharma America, Inc. 4. 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

2-week run-in period^2,3	12-week, double-blind treatment period^2,3	40-week, double-blind extension study¹
Randomization		Placebo group rolled into an active teartment arm¹
Placebo	Placebo (n=540)
	Gemtesa 75 mg (n=545)	Gemtesa 75 mg (n=273)
	Active Control (n=430)	Active Control (n=232)
Week 0	Week 12	Week 52

LS MEAN CHANGE FROM BASELINE
Week	12	16	24	44	52
Active control (n=106)	-1.8	-1.8	-2.0	-1.7	-1.7
GEMTESA 75 mg (n=143)	-1.9	-2.0	-2.1	-2.1	-2.2

LS MEAN CHANGE FROM BASELINE
Week	12	16	24	44	52
Active control (n=136)	-1.5	-1.9	-1.9	-1.8	-2.0
GEMTESA 75 mg (n=176)	-2.0	-2.2	-2.3	-2.5	-2.4

LS MEAN CHANGE FROM BASELINE
Week	12	16	24	44	52
Active control (n=136)	-2.2	-3.0	-3.0	-3.2	-3.2
GEMTESA 75 mg (n=176)	-3.0	-3.1	-3.3	-3.9	-3.4

% OF PATIENTS WITH 100% REDUCTION IN UUI
	12 Weeks	52 Weeks
Active control	(n=403) 23%*	(n=106) 34%†
GEMTESA 75 mg	(n=405) 29%*	(n=143) 41%†

The GEMTESA pivotal study had more than 1500 patients with OAB and the extension study had over 500 patients1

GEMTESA (vibegron) was studied in a phase 3, randomized, double-blind, placebo- and active-controlled multicenter study2,3

Safety and efficacy of GEMTESA were evaluated at 52 weeks1

Reductions in UUI per 24 hours at 52 weeks vs active control1,3*

Urge urinary incontinence (UUI)1,3*

Values

Reductions in micturition frequency per 24 hours at 52 weeks vs active control1*

Micturition frequency1,3*

Values

Reductions in urgency episodes per 24 hours at 52 weeks vs active control1*

Urgency episodes1,3*

Values

Reductions in UUI episodes of 100% at 12 weeks and at 52 weeks vs placebo and active control, respectively1,3*†

100% reduction in UUI episodes1,3

Values

Want more details about the pivotal 12-week study?

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

The GEMTESA pivotal study had more than 1500 patients with OAB and the extension study had over 500 patients¹

GEMTESA (vibegron) was studied in a phase 3, randomized, double-blind, placebo- and active-controlled multicenter study^2,3

Safety and efficacy of GEMTESA were evaluated at 52 weeks¹

Reductions in UUI per 24 hours at 52 weeks vs active control^1,3*

Urge urinary incontinence (UUI)^1,3*

Reductions in micturition frequency per 24 hours at 52 weeks vs active control¹*

Micturition frequency^1,3*

Reductions in urgency episodes
per 24 hours at 52 weeks vs
active control¹*

Urgency episodes^1,3*

Reductions in UUI episodes of 100% at 12 weeks and at 52 weeks vs placebo and active control, respectively^1,3*^†

100% reduction in UUI episodes^1,3