Sumitomo Pharma America Presents New Data on Vibegron at the 2025 American Urological Association Annual Meeting

– Data include results from COURAGE Phase 3 and COMPOSUR Phase 4 studies of vibegron (GEMTESA®) –

MARLBOROUGH, Mass., April 29, 2025 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA) presented new, positive data from the COURAGE Phase 3 open-label extension study of vibegron (GEMTESA®) in men living with overactive bladder (OAB) and receiving pharmacological therapy for benign prostatic hyperplasia (BPH).

Data presented from the Phase 3 COURAGE trial (URO-901-3006) included a total of 276 men with OAB symptoms receiving pharmacological therapy for BPH who participated in the open-label extension study. The primary outcome was to evaluate the long-term safety of vibegron 75 mg, which was well tolerated for up to 52 weeks in men with symptoms of OAB who were receiving pharmacological treatment for BPH. The data reveal that the efficacy results of treatment with vibegron 75 mg a day were sustained among those receiving vibegron for 52 weeks and improved after 28 weeks of vibegron treatment for those who received placebo during the first 12 weeks of a double-blind placebo-controlled study (URO-901-3005).

Sustained efficacy results in all secondary outcomes were observed, including mean daily micturitions, urgency episodes, nocturia episodes, urge urinary incontinence episodes, IPSS-Storage and volume voided per micturition. Vibegron demonstrated favorable long-term safety and efficacy, with no new safety signals compared to prior OAB studies.

At the conference SMPA also shared findings from the Phase 4 COMPOSUR, real-world study of vibegron in patients with OAB, which continue to support that it was generally safe and well-tolerated, with the majority of patients satisfied with treatment and remaining on vibegron after 12 months. Most common adverse events were urinary tract infection (4.0%), headache (2.7%), dizziness (2.2%) and diarrhea (2.0%).

"SMPA remains committed to advancing scientific innovation that helps the lives of the millions of patients suffering from OAB and receiving pharmacological therapy for BPH," said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. "These data continue to reaffirm vibegron's safety and tolerability."

Vibegron is approved for OAB with symptoms of urge urinary incontinence, urgency and urinary frequency in adults, and in December 2024, became the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

WARNINGS AND PRECAUTIONS
Urinary Retention
Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

Angioedema
Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

ADVERSE REACTIONS
Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

INDICATIONS AND USAGE
GEMTESA® is a beta-3 adrenergic agonist indicated for the treatment of:

• overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
• overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).

Please click here for full Prescribing Information.

About GEMTESA® (vibegron)
In the U.S., GEMTESA (vibegron) has been indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults since April 2021. GEMTESA was approved on December 18, 2024, for overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). GEMTESA works by selectively targeting β3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity.

About Overactive Bladder
Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), and frequent urination (usually eight or more times in 24 hours).⁷ Approximately 33 million U.S. adults experience the bothersome symptoms of OAB.¹

About Benign Prostatic Hyperplasia
Benign prostatic hyperplasia (BPH) is a condition in men in which the prostate gland is enlarged. Many men who are treated for symptoms are assumed to have an obstruction in the bladder caused by an enlarged prostate.^{4, 5} Even when the obstruction is alleviated by BPH treatment, unresolved symptoms of OAB may persist. About 60% of men with BPH are treated for lower urinary tract symptoms (LUTS).^{4, 5} LUTS can be divided into storage, voiding, and postmicturition symptoms.⁸ More than half of men with LUTS report storage symptoms, and about a quarter report voiding symptoms.5 This suggests that many men with a diagnosis of BPH may have overactive bladder.5

About Sumitomo Pharma
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.), and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

The Sumitomo corporate symbol mark is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd.

GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries.

©2025 Sumitomo Pharma America, Inc. All rights reserved.

References

1. Gomelsky A, Dmochowski RR. Update on the management of overactive bladder: patient considerations and adherence. Open Access J Urol. 2011;3:7-17. doi:10.2147/OAJU.S7233 
2. Deters LA. Benign Prostatic Hyperplasia (BPH).
   https://emedicine.medscape.com/article/437359-print. Updated March 22, 2023. Accessed December 18, 2024
3. Gomelsky A, Dmochowski RR. Overactive bladder in males. Ther Adv Urol. 2009;1(4):209-221. doi:10.1177/1756287209350383
4. Burnett AL, Walker DR, Feng Q, et al. Undertreatment of overactive bladder among men with lower urinary tract symptoms in the United States: a retrospective observational study. Neurourol Urodyn. 2020;39(5):1378-1386. doi:10.1002/nau.24348
5. Anger JT, Goldman HB, Luo X, et al. Patterns of medical management of overactive bladder (OAB) and benign prostatic hyperplasia (BPH) in the United States. Neurourol Urodyn. 2018;37(1):213-222. doi:10.1002/nau.23276
6. GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2024
7. Overactive bladder – symptoms and causes. Mayo Clinic. March 2 2024. Accessed December 18, 2024. https://www.mayoclinic.org/diseases-conditions/overactive-bladder/symptoms-causes/syc-20355715
8. Lepor H. Pathophysiology of lower urinary tract symptoms in the aging male population. Rev Urol. 2005;7 suppl 7(suppl 7):S3-S11. PMID: 16986059; PMCID: PMC1477625.

SOURCE Sumitomo Pharma America