Safety, efficacy of vibegron sustained in men with OAB treated for BPH

Findings from an open-label extension trial from the phase 3 COURAGE study (NCT03902080) of vibegron (Gemtesa) revealed that treatment of men with overactive bladder (OAB) symptoms who were receiving pharmalogic treatment for benign prostatic hyperplasia (BPH) was associated with positive long-term safety and efficacy for up to 52 weeks.^1,2

David R. Staskin, MD

The data were presented at the 2025 American Urological Association (AUA) Annual meeting in Las Vegas, Nevada, by David R. Staskin, MD, director of the Center for Male and Female Pelvic Health and associate professor of urology at Tufts University, Boston.

Previously reported data from COURAGE indicated that vibegron yielded significant, clinically meaningful improvements in OAB symptoms and was generally safe and well tolerated with adverse event (AE) rates similar to placebo,” the investigators wrote.³

The data presented at AUA 2025 were derived from an open-label extension trial of the COURAGE trial. It consisted of a 28-week treatment period in which the safety and efficacy of vibegron 75 mg was evaluated in men with OAB symptoms who were being treated with pharmacologic therapy for BPH. Patients in the US and Poland who completed the 24-week, randomized, placebo-controlled COURAGE trial were deemed eligible for enrollment in the extension trial. Patients had to continue receiving “a stable dose of BPH treatment with α-blocker with or without a 5-α-reductase inhibitor. Patients receiving vibegron in the original COURAGE study continued to receive once-daily vibegron 75 mg for the 28-week duration of the extension trial, and patients who received placebo in the original COURAGE study went on to receive the once-daily vibegron 75-mg regiment for 28 weeks.

The primary outcome of the extension study was long-term safety. This was assessed by evaluating AEs, clinical laboratory assessments, vital sign assessments, postvoid residual urine volume, and International Prostate Symptom Score (IPSS) total score. The secondary outcome was long-term efficacy. This was evaluated by examining change from baseline to week 52 for mean number of micturitions per day, urgency episodes per day, nocturia episodes per night, urge urinary incontinence episodes, IPSS storage score, and volume voided per micturition.

A total of 276 participants who completed the original COURAGE study were enrolled in the extension trial. 90.6% of this cohort completed the extension study; the most common reasons to discontinue the study included withdrawal on consent, occurring in 8 (2.9%) patients; and AEs, occurring in 6 (2.2%) patients. The baseline patient characteristics for the extension trial were reported to be similar to those seen in the original COURAGE trial.

Regarding safety, the investigators reported an overall incidence of AEs of 29.6%; the overall incidence of AEs in the double-blind treatment period of the COURAGE trial was 35.9%. A total of 7 (4.9%) patients experienced at least 1 treatment-related AE during the extension study. AEs that occurred in at least 2% of participants in the extension study included hypertension (6.3%), COVID-19 (5.6%), and increased hepatic enzyme (2.1%). The remaining AEs occurred in less than 2% of participants. There were 7 AEs that led to treatment discontinuation in 6 (4.2%) patients. Two of the discontinuations were related to AEs of urinary retention; neither of these was considered to be related to vibegron.

“Changes in vital signs (systolic and diastolic blood pressure and heart rate) were minimal, transient, and not considered clinically relevant… No new safety signals were identified in participants who received 24 weeks of placebo in the COURAGE trial followed by 28 weeks of vibegron treatment in the open-label COURAGE extension trial,” the investigators wrote.

In terms of efficacy, the investigators reported that the improvements in efficacy outcomes that had been previously reported in the original COURAGE trial “were generally sustained though the duration of the extension trial for each of the efficacy end points.”

“Improvements in efficacy outcomes were also observed following 28 weeks of vibegron treatment for participants who received placebo in the COURAGE trial and vibegron in the extension trial,” the investigators wrote.

REFERENCES

1. Staskin D, Owens-Grillo J, Thomas E, Peters KM, Rovner ES, Mujais S. The phase 3 open-label COURAGE extension study to evaluate the long-term safety and efficacy of vibegron in men with overactive bladder symptoms on pharmacotherapy for benign prostatic hyperplasia. J Urol. 2025;213(5S):e360. doi:10.1097/01.JU.0001109832.07222.c5.15

2. Sumitomo Pharma America to present new urology data at the 2025 American Urological Association Annual Meeting. News release. Sumitomo Pharma. April 15, 2025. Accessed April 30, 2025. https://news.us.sumitomo-pharma.com/2025-04-15-Sumitomo-Pharma-America-to-Present-New-Urology-Data-at-the-2025-American-Urological-Association-Annual-Meeting

3. Staskin D, Owens-Grillo J, Thomas E, Rovner E, Cline K, Mujais S. Efficacy and safety of vibegron for persistent symptoms of overactive bladder in men being pharmacologically treated for benign prostatic hyperplasia: Results from the phase 3 randomized controlled COURAGE trial. 2024;212(2):256-266. doi:10.1097/JU.0000000000003999