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 urgency1,2†
  • 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 placebo4‡

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 population1,4,6,7

  CHANGE FROM BASELINE AT
EFFICACY ANALYSIS
Adjusted least squares mean decrease in frequency of:
12 WEEKS1,4
(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 episodes4,6§
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 weeks1-3

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 weeks3†

*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 weeks1,3*

  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
 

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