Safety and Efficacy of Vibegron in Men With Overactive Bladder Symptoms on Pharmacotherapy for Benign Prostatic Hyperplasia: Results From the 28-Week Open-Label COURAGE Extension Trial Completing the 52-Week Phase 3 Evaluation

Purpose: In the 24-week, phase 3 COURAGE trial, vibegron was associated with significant improvements vs placebo in all primary and key secondary efficacy end points and was well tolerated in men with overactive bladder (OAB) on pharmacotherapy for benign prostatic hyperplasia (BPH). Safety and efficacy of vibegron were evaluated in a 28-week open-label extension study. Materials and Methods: Participants who completed COURAGE received once-daily vibegron 75 mg for 28 additional weeks in the extension study. The primary outcome was safety (adverse events [AEs], clinical laboratory assessments, vital signs, postvoid residual urine volume [PVR], and International Prostate Symptom Score [IPSS]-total score). Secondary outcomes were change from baseline to week 52 in mean daily micturitions, urgency episodes, nocturia episodes, urge urinary incontinence episodes, IPSS-storage score, and volume voided per micturition. Exploratory outcomes included change from baseline to week 52 in the OAB-questionnaire and Patient Global Impression scales. Results: Overall, 276 participants enrolled (vibegron, n = 142 [52-week cohort]; placebo, n = 134 [28-week cohort]); 90.6% completed the extension, with 9 participants discontinuing vibegron because of AEs. In the 52-week cohort, AE incidences were similar to double-blind treatment; there were no clinically relevant changes in laboratory parameters, vital signs or PVR, and median IPSS-total score decreased from baseline to week 52. Improvements in all secondary and exploratory outcomes were observed in the 52-week cohort. In the 28-week cohort, vibegron was well tolerated; secondary efficacy and exploratory outcomes generally improved with vibegron treatment. Conclusions: Vibegron demonstrated safety and efficacy over 52 weeks in men with OAB symptoms receiving pharmacotherapy for BPH.