Studied in more than 1500 patients with overactive bladder1,2
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
GEMTESA met efficacy endpoints1
Co-primary endpoints1,2
CFB in average daily number of micturitions and urge urinary incontinence (UUI) episodes
Key secondary endpoints1,2
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 demographics1,2
60
YEARS OLD
MEAN AGE
85%
FEMALE
15%
MALE
77% OAB WET†
23% OAB DRY†
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‡
†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.1
ACh=anticholinergic; CFB=change from baseline; FAS=full analysis set; FAS-I=full analysis set for incontinence.
Urge urinary incontinence (UUI)1,2
†Statistically significant improvement in UUI in the GEMTESA group vs placebo at Week 12 (P<0.0001).1,2
Micturition frequency1,2
*Statistically significant improvement in micturition frequency in the GEMTESA group vs placebo at Week 12 (P<0.001).1,2
≥75% reduction in daily UUI episodes2
*Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.2
Urgency episodes1,2
*P=0.002 vs placebo.1,2
References: 1. GEMTESA [prescribing information]. Irvine, CA: Urovant Sciences; 2020. 2. Data on file. Urovant Sciences. 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. 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 5. Zhou F, Newman DK, Palmer MH. Urinary urgency in working women: what factors are associated with urinary urgency progression? J Womens Health. 2018;27(5):575-583. doi:10.1089/jwh.2017.6555 6. 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 7. Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003;20(6):327-336. doi:10.1007/s00345-002-0301-4
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