GEMTESA SIGNIFICANTLY REDUCED
ALL 3 KEY OVERACTIVE BLADDER
SYMPTOMS* AT 12 WEEKS1-3
~60% LS mean reduction from baseline in UUI episodes at 12 weeks vs 40% with placebo (2.0 vs 1.4, respectively)1
*The 3 key symptoms of OAB are urgency, micturition frequency, and UUI/leakage.3
†Statistically significant improvement in UUI in the GEMTESA group vs placebo at Week 12 (P<0.0001).1,2,4
Urge urinary incontinence (UUI)1,2
At 12 weeks, GEMTESA (vibegron) demonstrated significant reductions in average daily UUI episodes1,2†
| 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 |
~60% LS mean reduction from baseline in UUI episodes at 12 weeks vs 40% with placebo (2.0 vs 1.4, respectively)1
*The 3 key symptoms of OAB are urgency, micturition frequency, and UUI/leakage.3
†Statistically significant improvement in UUI in the GEMTESA group vs placebo at Week 12 (P<0.0001).1,2,4
At 12 weeks, GEMTESA demonstrated significant reductions in average daily micturition frequency1,4*
Please see 12-week study design above.
Micturition frequency1,2
Values
| Week | 2 | 4 | 8 | 12 |
|---|---|---|---|---|
| Placebo (n=520) | -0.5 | -0.7 | -1.0 | -1.3 |
| GEMTESA 75mg (n=526) | -0.9 | -1.2 | -1.6 | -1.8 |
Patients taking GEMTESA had a ~16% LS mean change from baseline in micturition frequency vs ~11% with placebo (-1.8 vs -1.3, respectively)1
*Statistically significant improvement in micturition frequency in the GEMTESA group vs placebo at Week 12 (P<0.001).1,4
Please see 12-week study design above.
~43% of all OAB patients taking GEMTESA had a 50% reduction in urgency episodes vs placebo (~38%)2†
*P=0.002 vs placebo.1,2
†Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.2
Please see 12-week study design above.
Urgency episodes1,2
Values
| Week | 2 | 4 | 8 | 12 |
|---|---|---|---|---|
| Placebo (n=520) | -0.9 | -1.1 | -1.6 | -2.0 |
| GEMTESA 75mg (n=526) | -1.5 | -1.9 | -2.4 | -2.7 |
~43% of all OAB patients taking GEMTESA had a 50% reduction in urgency episodes vs placebo (~38%)2†
*P=0.002 vs placebo.1,2
†Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.2
Please see 12-week study design above.
≥75% reduction in daily UUI episodes2
Values
| 12 Weeks | |
|---|---|
| Placebo (n=405) | 36.8% |
| GEMTESA 75mg (n=403) | 52.4% |
*Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.2
*Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.2
Please see 12-week study design above.
GEMTESA is the first and only beta-3
agonist with urgency reduction data in
its label1
- Urgency is the hallmark OAB symptom5,6
- ~60% of individuals with OAB symptoms have urgency episodes without leakage7
