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

12-week Study Design

Extension Study Design

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†

Older Adults Data Analysis

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

^†P<0.001 vs placebo.2

Urge urinary incontinence (UUI)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

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

In patients aged 75+ years²

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

^*P<0.001 vs placebo.

Please see older adults data analysis above.

(UUI)²

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

In patients aged 65+ years²

GEMTESA demonstrated significant reductions in average daily micturition frequency at 12 weeks (co-primary endpoint) vs placebo^2*

^*P<0.001 vs placebo.

Please see older adults data analysis above.

Micturition frequency²

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

In patients aged 75+ years²

GEMTESA demonstrated significant reductions in average daily micturition frequency at 12 weeks (co-primary endpoint) vs placebo^2*

^*P<0.05 vs placebo.

Please see older adults data analysis above.

Micturition frequency²

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

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 placebo^2*

^*P<0.001 vs placebo.

Please see older adults data analysis above.

Urgency episodes²

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

In patients aged 75+ years²

GEMTESA demonstrated significant reductions in average daily urgency episodes—need to urinate immediately—at 12 weeks vs placebo^2*

^*P<0.01 vs placebo.

Please see older adults data analysis above.

Urgency episodes²

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

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%

1.7%

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%

1.2%

0.4%

2.7%

1.7%

DYSPNEA

0.7%

0.2%

1.6%

4.0%

1.7%

URINARY RETENTION

0.6%

0.4%

1.2%

0.4%

2.7%

FLATULENCE

0.4%

0.6%

0.8%

0.9%

2.7%

SOMNOLENCE

0.4%

0.8%

0.4%

2.7%

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)

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

EXTENSION STUDY DESIGN

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
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

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

*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

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

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

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 in 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.

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 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

Urge urinary incontinence (UUI)²

(UUI)²

Micturition frequency²

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

Urgency episodes²

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

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

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

12-week, double-blind treatment period

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

GEMTESA met efficacy endpoints¹

12-week patient demographics^1,2

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‡

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

Study design description

Study endpoints^1-3

52-week patient demographics^1-3

Treatment naïve or had prior ACh or beta-3 agonist use in 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†

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

More than 600 older adults evaluated
at 12 weeks²

GEMTESA met efficacy endpoints²

GEMTESA PATIENT DEMOGRAPHICS^1,2

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§

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

Urge urinary incontinence (UUI)2

Values

(UUI)2

Values

Micturition frequency2

Values

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

Urgency episodes2

Values

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?

12-week, double-blind treatment period

Studied in more than 1500 patients with overactive bladder1,2

Values

GEMTESA met efficacy endpoints1

12-week patient demographics1,2

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/day1‡

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

Study design description

Values

Study endpoints1-3

52-week patient demographics1-3

Treatment naïve or had prior ACh or beta-3 agonist use in 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/day2†

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

More than 600 older adults evaluated at 12 weeks2

GEMTESA met efficacy endpoints2

GEMTESA PATIENT DEMOGRAPHICS1,2

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/day2§

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

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

Urge urinary incontinence (UUI)²

(UUI)²

Micturition frequency²

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

Urgency episodes²

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

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

GEMTESA met efficacy endpoints¹

12-week patient demographics^1,2

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‡

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

Study endpoints^1-3

52-week patient demographics^1-3

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†

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

More than 600 older adults evaluated
at 12 weeks²

GEMTESA met efficacy endpoints²

GEMTESA PATIENT DEMOGRAPHICS^1,2

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§