LONG-TERM CARE (LTC) RESIDENTS WITH OVERACTIVE BLADDER (OAB) MAY BENEFIT FROM GEMTESA

GEMTESA 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 65 years of age and older and younger adult patients

URGENCY IMPROVEMENT

Proven urgency reduction data in label¹
Statistically significant reduction of all 3 key OAB symptoms* vs placebo at 12 weeks—including urgency^1,2†
Reductions in 3 key OAB symptoms* at 12 weeks in patients aged 65+ and 75+³
~43% of all OAB patients taking GEMTESA had a 50% reduction in urgency episodes at week 12 vs 38% with placebo^4‡

ONE
CRUSHABLE DOSE

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

SAFETY & TOLERABILITY

No blood pressure warning in its label¹
No drug interaction with CYP2D6 substrate¹
No known association with cognitive decline for the beta-3 agonist class⁵
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

*The 3 key symptoms of OAB are urgency, micturition frequency, and urge urinary incontinence (UUI)/leakage.²

^†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.^1,4

^‡Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the EMPOWUR trial. Unadjusted placebo percentage was 38.3%.⁴

GEMTESA was evaluated at 12 weeks and 52 weeks in the overall study population^1,4,6,7

	CHANGE FROM BASELINE AT
EFFICACY ANALYSIS Adjusted least squares mean decrease in frequency of:	12 WEEKS^1,4 (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.⁴

*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).⁴

In the elderly 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 65 years of age and older and younger adult patients

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 years³

GEMTESA demonstrated significant reductions in average daily UUI episodes at 12 weeks^3†

*The 3 key symptoms of OAB are urgency, micturition frequency, and urge urinary incontinence (UUI)/leakage.²

^†P<0.001 vs placebo.³

Urge urinary incontinence (UUI)³

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.²

^†P<0.001 vs placebo.³

In patients ≥75 years³

GEMTESA demonstrated significant reductions in average daily UUI episodes at 12 weeks³*

*P<0.001 vs placebo.

Please see elderly data analysis above.

Urge urinary incontinence (UUI)³

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 years³

GEMTESA demonstrated significant reductions in average daily micturition frequency at 12 weeks³*

*P<0.001 vs placebo.

Please see elderly data analysis above.

Micturition frequency³

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 years³

GEMTESA demonstrated significant reductions in average micturition frequency at 12 weeks³*

*P<0.05 vs placebo.

Please see elderly data analysis above.

Micturition frequency³

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.

In patients aged ≥65 years³

GEMTESA demonstrated significant reductions in average daily urgency episodes—need to urinate immediately—at 12 weeks³*

*P<0.01 vs placebo.

Please see elderly data analysis above.

Urgency episodes³

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 years³

GEMTESA demonstrated significant reductions in average daily urgency episodes—need to urinate immediately—at 12 weeks³*

*P<0.01 vs placebo.

Please see elderly data analysis above.

Urgency episodes³

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 and tolerability of GEMTESA for elderly patients³

Adverse events (AEs) with an incidence of ≥2% compared with and exceeding placebo up to 12 weeks^1,3*

	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)
HEADACHE	4.0%	2.4%	4.5%	2.2%	2.7%	3.3%
DRY MOUTH	1.7%	0.9%	3.3%	0.9%	1.3%	1.7%
UPPER RESPIRATORY TRACT INFECTION	2.0%	0.7%	3.3%	0.9%	4.0%	1.7%
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%
URINARY TRACT INFECTION	5.0%	6.1%	5.7%	7.9%	8.0%	6.7%
DYSPNEA	0.7%	0.2%	1.6%	0%	4.0%	0%
URINARY RETENTION	0.6%	0.4%	1.2%	0.4%	2.7%	0%
RASH	0.7%	0.7%	1.2%	0.4%	2.7%	1.7%
SOMNOLENCE	0.4%	0.4%	0.8%	0.4%	2.7%	0%
FLATULENCE	0.4%	0.6%	0.8%	0.9%	2.7%	0%

Safety results to consider for elderly patients assessed at 12 weeks³

No overall differences in safety or effectiveness of GEMTESA have been observed between patients 65 years of age and older and younger adult patients
Less than 2% of elderly patients aged 65+ and 75+ taking GEMTESA experienced hypertension (1.2% and 1.3%, respectively) vs placebo (3.1% and 3.3%, respectively)
Incidence of cardiovascular-associated adverse events (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 elderly patients aged 65+ and 75+ (1.6% and 4%, respectively)

*Includes all AEs occurring in ≥2% of the GEMTESA group and more frequently than placebo.

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

ELDERLY SUBPOPULATION:
12-WEEK, DOUBLE-BLIND TREATMENT PERIOD³

More than 600 elderly patients evaluated at 12 weeks³

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 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

ELDERLY SUBPOPULATION: 12-WEEK, DOUBLE-BLIND TREATMENT PERIOD³

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

Randomization

Placebo Placebo 65+ (n=330) 75+ (m=57)*

Gemtesa 75 mg 65+ (n=242) 75+ (n=75)*

Active Control 65+ (n=166) 75+ (n=47)*

Week 0 Week 12

Diagram showing the structure of the GEMTESA® elderly subpopulation study. Over 600 elderly patients participated in the extension study. — Values

ELDERLY SUBPOPULATION: 12-WEEK, DOUBLE-BLIND TREATMENT PERIOD³

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

Randomization

Placebo Placebo 65+ (n=330) 75+ (m=57)*

Gemtesa 75 mg 65+ (n=242) 75+ (n=75)*

Active Control 65+ (n=166) 75+ (n=47)*

Week 0 Week 12

GEMTESA met efficacy endpoints³

Co-primary endpoints

Change from baseline in average daily number of UUI episodes
Change from baseline in average daily number of micturitions

Key secondary endpoints

Change from baseline in average daily number of urgency episodes

GEMTESA PATIENT DEMOGRAPHICS^1,3

OVERALL POPULATION

(n=526)

85.4^%

FEMALE

≥65^†

YEARS OLD _(n=242)

84.3^%

FEMALE

≥75^‡

YEARS OLD _(n=75)

78.7^%

FEMALE

Prior therapy and treatment naïve

76.6^% OAB WET

79.3^% OAB WET

78.7^% OAB WET

Symptoms of OAB ≥3 months with an average ≥8 micturitions/day and ≥1 UUI/day, or average ≥8 micturitions/day and mean ≥3 urgency episodes/day³

*The 75+ population is a subset of the 65+ patient population.³

^†Percentage calculated from the subset of patients aged ≥65 years in each treatment group.³

^‡Percentage calculated from the subset of patients aged ≥75 years in each treatment group.³

OAB=overactive bladder; UUI=urge urinary incontinence.

More than 500 patients were studied
in the 40-week extension¹

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 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

Primary and secondary 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 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 in average daily number of: Micturitions UUI episodes (wet OAB) Urgency episodes

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

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

78% OAB WET

22% OAB DRY

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†

^†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; OAB=overactive bladder; UUI=urge urinary 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
Percentage of OAB-wet patients at week 12 with ≥75% reduction in total number of UUI episodes in 24 hours*
Percentage 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 mean ≥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

^‡Urge urinary incontinence 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; UUI=urge urinary 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]. Irvine, CA: Urovant Sciences; 2020. 2. 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 3. 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 4. Data on file. Urovant Sciences. 5. 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 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. 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

2-week run-in period	12-Week, double-blind treatment period
Randomization
Placebo	Placebo 65+ (n=330) 75+ (m=57)*
	Gemtesa 75 mg 65+ (n=242) 75+ (n=75)*
	Active Control 65+ (n=166) 75+ (n=47)*
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*

LONG-TERM CARE (LTC) RESIDENTS WITH OVERACTIVE BLADDER (OAB) MAY BENEFIT FROM GEMTESA

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

URGENCY IMPROVEMENT

ONE CRUSHABLE DOSE

SAFETY & TOLERABILITY

GEMTESA was evaluated at 12 weeks and 52 weeks in the overall study population1,4,6,7

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

Urge urinary incontinence (UUI)3

Values

Urge urinary incontinence (UUI)3

Values

Micturition frequency3

Values

Micturition frequency3

Values

Urgency episodes3

Values

Urgency episodes3

Values

Established safety and tolerability of GEMTESA for elderly patients3

Safety results to consider for elderly patients assessed at 12 weeks3

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

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

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

ONE
CRUSHABLE DOSE

GEMTESA was evaluated at 12 weeks and 52 weeks in the overall study population^1,4,6,7

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

Urge urinary incontinence (UUI)³

Urge urinary incontinence (UUI)³

Micturition frequency³

Micturition frequency³

Urgency episodes³

Urgency episodes³

Established safety and tolerability of GEMTESA for elderly patients³

Safety results to consider for elderly patients assessed at 12 weeks³

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

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