Discover the benefits of GEMTESA for long-term care (LTC) residents with overactive bladder (OAB)

GEMTESA (vibegron) offers symptom improvement, simple dosing, and a demonstrated safety and tolerability profile for patients with OAB¹

No overall differences in safety or effectiveness of GEMTESA have been observed between patients aged 65+ and younger adult patients²

PROVEN EFFICACY
IN OLDER ADULTS

First and only beta-3 agonist with proven urgency reduction data in its label¹
Statistically significant reduction in all 3 key OAB symptoms* vs placebo at 12 weeks—including urgency^1,3†
Reductions in 3 key OAB symptoms* at 12 weeks in patients aged 65+ and 75+²

ONE
CRUSHABLE DOSE

First and only beta-3 agonist with a once-daily 75-mg dose with no titration, to be taken with or without food, and swallowed whole with a glass of water¹
Crushability. In adults, GEMTESA tablets may be crushed, mixed with a tablespoon (~15 mL) of applesauce and taken immediately with a glass of water¹

ESTABLISHED SAFETY
FOR OLDER ADULTS

First and only beta-3 agonist with no blood pressure warning in its label¹
First and only beta-3 agonist with no drug interaction with CYP2D6 substrates (medications commonly taken by LTC residents)¹
- Digoxin drug interaction was identified with GEMTESA. Measure serum digoxin concentrations before initiating GEMTESA. Monitor serum digoxin concentrations to titrate digoxin dose to desired clinical effect. Continue monitoring digoxin concentration upon discontinuation of GEMTESA and adjust digoxin dose as needed¹
No known association with cognitive decline, including dementia, for the beta-3 agonist class^4,5

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

^†The efficacy of GEMTESA was evaluated in a pivotal 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.^1,5

GEMTESA was evaluated at 12 weeks and 52 weeks in the overall study population^1,6,7

	CHANGE FROM BASELINE AT
EFFICACY ANALYSIS Adjusted least squares mean decrease in frequency of:	12 WEEKS^1,7 (pivotal study)	52 WEEKS⁶ (extension study)
URGE URINARY INCONTINENCE EPISODES (UUI)	GEMTESA 75 mg (n=403) -2.0* Placebo (n=405) -1.4	GEMTESA 75 mg (n=143) -2.2 Active Control (n=106) -1.7
MICTURITION EPISODES	GEMTESA 75 mg (n=526) -1.8^† Placebo (n=520) -1.3	GEMTESA 75 mg (n=176) -2.4 Active Control (n=136) -2.0
URGENCY EPISODES	GEMTESA 75 mg (n=526) -2.7^‡ Placebo (n=520) -2.0	GEMTESA 75 mg (n=176) -3.4 Active Control (n=136) -3.2
EXPLORATORY RESPONDER ANALYSIS % of patients achieving 100% reduction in UUI episodes^4,6§	GEMTESA 75 mg (n=403) 28.8% Placebo (n=405) 22.5%	GEMTESA 75 mg (n=143) 40.8% Active Control (n=106) 34.2%

Efficacy analyses were performed using the FAS-EXT, except for incontinence episode endpoints, which used the FAS-EXT-I.⁷

*P<0.0001 vs placebo.¹

^†P<0.001 vs placebo.¹

^‡P=0.002 vs placebo.¹

^§Data were based on an exploratory endpoint analysis of patients with 100% reduction in UUI from baseline at week 52 (n=143).⁷

In the older adult subpopulation, reductions in all 3 key OAB symptoms* were consistent with the overall study population at 12 weeks^1-3

No overall differences in safety or effectiveness of GEMTESA have been observed between patients aged 65+ and younger adult patients²

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

In patients aged 65+ years²

GEMTESA demonstrated significant reductions in average daily UUI episodes at 12 weeks (co-primary endpoint) vs placebo^2†

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

^†P<0.001 vs placebo.²

Urge urinary incontinence (UUI)²

Graph showing reductions in urge urinary incontinence (UUI) episodes at 12 weeks for patients aged 65 years and older. — Values

LEAST SQUARES (LS) MEAN CHANGE FROM BASELINE

Week 2 4 8 12

Placebo (n=168) -0.9 -1.1 -1.2 -1.2

GEMTESA 75 mg (n=192) -1.5 -1.8 -1.8 -2.0

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

^†P<0.001 vs placebo.²

In patients aged 75+ years²

GEMTESA demonstrated significant reductions in average daily UUI episodes at 12 weeks (co-primary endpoint) vs placebo²*

*P<0.001 vs placebo.

Please see older adults data analysis above.

UUI²

Graph showing reductions in urge urinary incontinence (UUI) episodes at 12 weeks for patients aged 75 years and older. — Values

LS MEAN CHANGE FROM BASELINE

Week 2 4 8 12

Placebo (n=44) -0.5 -0.6 -0.3 -0.4

GEMTESA 75 mg (n=59) -1.6 -1.7 -1.8 -2.0*

*P<0.001 vs placebo.

In patients aged 65+ years²

GEMTESA demonstrated significant reductions in average daily micturition frequency at 12 weeks (co-primary endpoint) vs placebo²*

*P<0.001 vs placebo.

Please see older adults data analysis above.

Micturition frequency²

Graph showing reductions in average daily micturition frequency at 12 weeks for patients aged 65 years and older. — Values

LS MEAN CHANGE FROM BASELINE

Week 2 4 8 12

Placebo (n=220) -0.3 -0.5 -0.7 -1.0

GEMTESA 75 mg (n=242) -1.1 -1.4 -1.8 -1.9*

*P<0.001 vs placebo.

In patients aged 75+ years²

GEMTESA demonstrated significant reductions in average daily micturition frequency at 12 weeks (co-primary endpoint) vs placebo²*

*P<0.05 vs placebo.

Please see older adults data analysis above.

Micturition frequency²

Graph showing reductions in average daily micturition frequency at 12 weeks for patients aged 75 years and older. — Values

LS MEAN CHANGE FROM BASELINE

Week 2 4 8 12

Placebo (n=57) -0.7 -0.7 -1.0 -1.2

GEMTESA 75 mg (n=75) -1.3 -1.8 -2.1 -2.1*

*P<0.05 vs placebo.

Urgency is the hallmark OAB symptom^8,9

While urgency is a critical factor in the diagnosis of OAB, the symptom often remains unreported and undiagnosed^8,9

In a recently published study:

Urgency progressed in severity in older patients
Identifying and treating urgency in female individuals with lower urinary tract symptoms could help delay or possibly prevent progression as they age⁸

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

In patients aged 65+ years²

GEMTESA demonstrated significant reductions in average daily urgency episodes—need to urinate immediately—at 12 weeks vs placebo²*

*P<0.01 vs placebo.

Please see older adults data analysis above.

Urgency episodes²

Graph showing reductions in average daily urgency episodes at 12 weeks for patients aged 65 years and older. — Values

LS MEAN CHANGE FROM BASELINE

Week 2 4 8 12

Placebo (n=220) -0.9 -1.2 -1.3 -1.7

GEMTESA 75 mg (n=242) -1.6 -2.1 -2.5 -2.7*

*P<0.01 vs placebo.

In patients aged 75+ years²

GEMTESA demonstrated significant reductions in average daily urgency episodes—need to urinate immediately—at 12 weeks vs placebo²*

*P<0.01 vs placebo.

Please see older adults data analysis above.

Urgency episodes²

Graph showing reductions in average daily urgency episodes at 12 weeks for patients aged 75 years and older. — Values

LS MEAN CHANGE FROM BASELINE

Week 2 4 8 12

Placebo (n=57) -0.7 -0.8 -0.7 -0.9

GEMTESA 75 mg (n=75) -1.3 -1.7 -2.2 -2.6*

*P<0.01 vs placebo.

Established safety of GEMTESA for older adults at 12 weeks^1,2

Adverse events (AEs) with an incidence of ≥2% compared with and exceeding placebo up to 12 weeks^1,2

	OVERALL STUDY POPULATION		PATIENTS 65+		PATIENTS 75+
	GEMTESA (n=545)	Placebo (n=540)	GEMTESA (n=246)	Placebo (n=228)	GEMTESA (n=75)	Placebo (n=60)
URINARY TRACT INFECTION	5.0%	6.1%	5.7%	7.9%	8.0%	6.7%
HEADACHE	4.0%	2.4%	4.5%	2.2%	2.7%	3.3%
NASOPHARYNGITIS	2.8%	1.7%	2.4%	2.2%	2.7%	3.3%
DIARRHEA	2.2%	1.1%	2.4%	0.9%	4.0%	3.3%
NAUSEA	2.2%	1.1%	2.0%	1.3%	2.7%	3.3%
UPPER RESPIRATORY TRACT INFECTION	2.0%	0.7%	3.3%	0.9%	4.0%	1.7%
DRY MOUTH	1.7%	0.9%	3.3%	0.9%	1.3%	1.7%
RASH	0.7%	0.7%	1.2%	0.4%	2.7%	1.7%
DYSPNEA	0.7%	0.2%	1.6%	0%	4.0%	1.7%
URINARY RETENTION	0.6%	0.4%	1.2%	0.4%	2.7%	0%
FLATULENCE	0.4%	0.6%	0.8%	0.9%	2.7%	0%
SOMNOLENCE	0.4%	0.4%	0.8%	0.4%	2.7%	0%

Safety results to consider for older adults assessed at 12 weeks²

No overall differences in safety or effectiveness of GEMTESA have been observed between patients aged 65+ or 75+ and younger adult patients
Incidence of cardiovascular-associated AEs, including hypertension (1.3%) and increased blood pressure (0%), was low for elderly patients aged 75+ taking GEMTESA vs placebo (3.3% and 1.7%, respectively)
Rates of discontinuation due to AEs were low for patients aged 65+ and 75+ (1.6% and 4%, respectively)

Less than 2% of patients aged 65+ and 75+ taking GEMTESA experienced hypertension (1.2% and 1.3%, respectively) vs placebo (3.1% and 3.3%, respectively)²

Want to know more about efficacy in the overall study population?

Pivotal efficacy data

Did you know there are extension study data available for GEMTESA?

Extension study data

OLDER ADULT SUBPOPULATION:
12-WEEK, DOUBLE-BLIND TREATMENT PERIOD²

More than 600 older adults evaluated at 12 weeks²

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).

In a post hoc subpopulation analysis, efficacy and safety with GEMTESA was assessed in 647 patients aged 65+ and 75+ years (a subset of the population aged 65+ years). This 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.

Values

OLDER ADULT SUBPOPULATION: 12-WEEK, DOUBLE-BLIND TREATMENT PERIOD³

2-week run-in period 12-Week, double-blind treatment period

Randomization

Placebo Placebo 65+ (n=228) 75+ (n=60)*

Gemtesa 75 mg 65+ (n=247) 75+ (n=75)*

Active Control 65+ (n=172) 75+ (n=48)*

Week 0 Week 12

Diagram showing the structure of the GEMTESA® older adult subpopulation study. Over 600 older adults participated in the extension study. — Values

OLDER ADULT SUBPOPULATION: 12-WEEK, DOUBLE-BLIND TREATMENT PERIOD³

2-week run-in period 12-Week, double-blind treatment period

Randomization

Placebo Placebo 65+ (n=228) 75+ (n=60)*

Gemtesa 75 mg 65+ (n=247) 75+ (n=75)*

Active Control 65+ (n=172) 75+ (n=48)*

Week 0 Week 12

GEMTESA met efficacy endpoints²

Co-primary endpoints

Change from baseline in average daily number of urge urinary incontinence (UUI) episodes
Change from baseline in average daily number of micturitions

Key secondary endpoint

Change from baseline in average daily number of urgency episodes

GEMTESA PATIENT DEMOGRAPHICS^1,2

OVERALL POPULATION

(n=526)

85.4^%

FEMALE

76.6^% OAB WET^§

≥65^†

YEARS OLD

(n=242)

84.3^%

FEMALE

79.3^% OAB WET^§

≥75^‡

YEARS OLD

(n=75)

78.7^%

FEMALE

78.7^% OAB WET^§

Prior therapy and treatment naïve

Symptoms of OAB ≥3 months with an average ≥8 micturitions/day and ≥1 UUI/day, or an average ≥8 micturitions/day, ≥3 urgency episodes/day^2§

*The 75+ population is a subset of the 65+ patient population.²

^†Percentage calculated from the subset of patients aged ≥65 years in each treatment group.²

^‡Percentage calculated from the subset of patients aged ≥75 years in each treatment group.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.⁷

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.

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 1,500 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 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

Treatment naïve or had prior ACh or beta-3 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^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.²

^‡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. 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 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. Welk B, McArthur E. Increased risk of dementia among patients with overactive bladder treated with an anticholinergic medication compared to a beta-3 agonist: a population-based cohort study. BJU Int. 2020;126(1):183-190. doi:10.1111/bju.15040 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. 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 7. Data on file. Sumitomo Pharma America, Inc. 8. Zhou F, Newman DK, Palmer MH. Urinary urgency in working women: what factors are associated with urinary urgency progression? J Womens Health (Larchmt). 2018;27(5):575-583. doi:10.1089/jwh.2017.6555 9. 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

2-week run-in period	12-Week, double-blind treatment period
Randomization
Placebo	Placebo 65+ (n=228) 75+ (n=60)*
	Gemtesa 75 mg 65+ (n=247) 75+ (n=75)*
	Active Control 65+ (n=172) 75+ (n=48)*
Week 0	Week 12

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

LEAST SQUARES (LS) MEAN CHANGE FROM BASELINE
Week	2	4	8	12
Placebo (n=168)	-0.9	-1.1	-1.2	-1.2
GEMTESA 75 mg (n=192)	-1.5	-1.8	-1.8	-2.0

LS MEAN CHANGE FROM BASELINE
Week	2	4	8	12
Placebo (n=44)	-0.5	-0.6	-0.3	-0.4
GEMTESA 75 mg (n=59)	-1.6	-1.7	-1.8	-2.0*

LS MEAN CHANGE FROM BASELINE
Week	2	4	8	12
Placebo (n=220)	-0.3	-0.5	-0.7	-1.0
GEMTESA 75 mg (n=242)	-1.1	-1.4	-1.8	-1.9*

LS MEAN CHANGE FROM BASELINE
Week	2	4	8	12
Placebo (n=57)	-0.7	-0.7	-1.0	-1.2
GEMTESA 75 mg (n=75)	-1.3	-1.8	-2.1	-2.1*

Discover the benefits of GEMTESA for long-term care (LTC) residents with overactive bladder (OAB)

GEMTESA (vibegron) offers symptom improvement, simple dosing, and a demonstrated safety and tolerability profile for patients with OAB1

PROVEN EFFICACY IN OLDER ADULTS

ONE CRUSHABLE DOSE

ESTABLISHED SAFETY FOR OLDER ADULTS

GEMTESA was evaluated at 12 weeks and 52 weeks in the overall study population1,6,7

In the older adult subpopulation, reductions in all 3 key OAB symptoms* were consistent with the overall study population at 12 weeks1-3

In patients aged 65+ years2

GEMTESA demonstrated significant reductions in average daily UUI episodes at 12 weeks (co-primary endpoint) vs placebo2†

Urge urinary incontinence (UUI)2

Values

In patients aged 75+ years2

GEMTESA demonstrated significant reductions in average daily UUI episodes at 12 weeks (co-primary endpoint) vs placebo2*

UUI2

Values

In patients aged 65+ years2

GEMTESA demonstrated significant reductions in average daily micturition frequency at 12 weeks (co-primary endpoint) vs placebo2*

Micturition frequency2

Values

In patients aged 75+ years2

GEMTESA demonstrated significant reductions in average daily micturition frequency at 12 weeks (co-primary endpoint) vs placebo2*

Micturition frequency2

Values

Urgency is the hallmark OAB symptom8,9

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

In patients aged 65+ years2

GEMTESA demonstrated significant reductions in average daily urgency episodes—need to urinate immediately—at 12 weeks vs placebo2*

Urgency episodes2

Values

In patients aged 75+ years2

GEMTESA demonstrated significant reductions in average daily urgency episodes—need to urinate immediately—at 12 weeks vs placebo2*

Urgency episodes2

Values

Established safety of GEMTESA for older adults at 12 weeks1,2

Safety results to consider for older adults assessed at 12 weeks2

Want to know more about efficacy in the overall study population?

Did you know there are extension study data available for GEMTESA?

GEMTESA (vibegron) offers symptom improvement, simple dosing, and a demonstrated safety and tolerability profile for patients with OAB¹

PROVEN EFFICACY
IN OLDER ADULTS

ONE
CRUSHABLE DOSE

ESTABLISHED SAFETY
FOR OLDER ADULTS

GEMTESA was evaluated at 12 weeks and 52 weeks in the overall study population^1,6,7

In the older adult subpopulation, reductions in all 3 key OAB symptoms* were consistent with the overall study population at 12 weeks^1-3

In patients aged 65+ years²

GEMTESA demonstrated significant reductions in average daily UUI episodes at 12 weeks (co-primary endpoint) vs placebo^2†

Urge urinary incontinence (UUI)²

In patients aged 75+ years²

GEMTESA demonstrated significant reductions in average daily UUI episodes at 12 weeks (co-primary endpoint) vs placebo²*

UUI²

In patients aged 65+ years²

GEMTESA demonstrated significant reductions in average daily micturition frequency at 12 weeks (co-primary endpoint) vs placebo²*

Micturition frequency²

In patients aged 75+ years²

GEMTESA demonstrated significant reductions in average daily micturition frequency at 12 weeks (co-primary endpoint) vs placebo²*

Micturition frequency²

Urgency is the hallmark OAB symptom^8,9

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

In patients aged 65+ years²

GEMTESA demonstrated significant reductions in average daily urgency episodes—need to urinate immediately—at 12 weeks vs placebo²*

Urgency episodes²

In patients aged 75+ years²

GEMTESA demonstrated significant reductions in average daily urgency episodes—need to urinate immediately—at 12 weeks vs placebo²*

Urgency episodes²

Established safety of GEMTESA for older adults at 12 weeks^1,2

Safety results to consider for older adults assessed at 12 weeks²