Sumitomo Pharma America Shares Promising Vibegron Data at AUA 2025 Annual Meeting

Introduction

At the recent 2025 American Urological Association (AUA) Annual Meeting, Sumitomo Pharma America, Inc. (SMPA) presented noteworthy findings from its ongoing clinical research on vibegron, branded as GEMTESA®. This data underscores the effectiveness and safety profile of vibegron, particularly for men struggling with overactive bladder (OAB) who are also undergoing treatment for benign prostatic hyperplasia (BPH).

Study Overview and Results

The presentation featured results from the COURAGE Phase 3 extension study, which was an open-label trial including 276 men suffering from OAB symptoms while receiving pharmacological therapy for BPH. The primary goal was to assess the long-term safety of administering 75 mg of vibegron daily, a regimen noted for its tolerability over a span of 52 weeks.

The results were quite promising: not only were the efficacy results stable throughout the 52-week period, but notable improvements were also observed after a mere 28 weeks for those who had initially been on a placebo during the first 12 weeks of the study. This study evaluated multiple endpoints, including factors like mean daily micturitions and urgency episodes, highlighting sustained efficacy across the board.

Sustained Efficacy and Safety

Furthermore, secondary outcomes indicated that vibegron positively impacted daily urinary functions, such as nighttime urination incidents and urgency levels. This trial helped to reinforce vibegron's long-term safety and efficacy, showing no new safety signals compared to previous studies on OAB.

The AUA conference also spotlighted findings from the Phase 4 COMPOSUR real-world study involving vibegron in OAB patients. This research reiterated the medication's safety and general tolerance, with a high level of patient satisfaction; most participants opted to continue on vibegron after a full year of treatment. The commonly reported adverse reactions included urinary tract infections, headaches, dizziness, and diarrhea, all of which occurred at rates below 5%.

Commitment to Innovation

Tsutomu Nakagawa, Ph.D., and President of SMPA expressed a steadfast commitment to scientific innovation aimed at enhancing the lives of millions affected by OAB and BPH. "These findings strengthen the case for vibegron as a viable treatment option for men grappling with these dual challenges," he stated.

Vibegron Overview and Indications

Vibegron, a beta-3 adrenergic agonist, has been pivotal in managing OAB symptoms characterized by urgency, incontinence, and frequency in adults since its endorsement in April 2021. As of December 2024, it became the only beta-3 agonist permitted to treat adult males with OAB symptoms while under pharmacological therapy for BPH.

Understanding OAB and BPH

Overactive bladder is a significant health issue affecting nearly 33 million adults in the U.S., showcasing symptoms like the sudden urge to urinate and frequent urination, which can be disruptive to daily life. On the other hand, BPH often leads to urinary tract issues when the prostate enlarges. Research indicates that about 60% of men diagnosed with BPH will undergo treatment for lower urinary tract symptoms, and many of them may concurrently exhibit symptoms of OAB.

About Sumitomo Pharma

Sumitomo Pharma Co., Ltd., headquartered in Japan, is devoted to addressing various patient needs across several domains like oncology and urology. Sumitomo Pharma America represents the company in the U.S., with a strong commitment to research and development aimed at bringing innovative therapies quickly to those in need. With a diverse pipeline of products and partnerships, SMPA aims to continue making significant strides in pharmaceutical care. For further information, visit Sumitomo Pharma America.

Conclusion

This new data on vibegron marks an encouraging advancement in the treatment landscape for OAB among men receiving concurrent BPH treatment. As research continues, the prospect of improving the quality of life for millions remains a priority for Sumitomo Pharma America.