Sumitomo Pharma America Inc (SMPA), part of Japan-based global pharmaceutical company Sumitomo Pharma Co Ltd, announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for GEMTESA (vibegron) for treating overactive bladder (OAB) symptoms.

GEMTESA is a beta-3 adrenergic receptor agonist, dosed once-daily (75 mg), intended for the treatment of men with OAB symptoms, such as urge urinary incontinence, urgency and urinary frequency, who are receiving pharmacological therapy for benign prostatic hyperplasia (BPH).

The product is the first and only such agonist approved to treat subjects living with OAB and being treated for BPH. It is now available for prescription in the United States.

The FDA approval was based on a Phase 3 study of vibegron compared to placebo over 24 weeks in approximately 1,100 men. All co-primary endpoints at Week 12 were met.

Tsutomu Nakagawa, PhD, president and CEO of SMPA, said: "Millions of patients suffer from OAB along with existing BPH. OAB is a urological condition that has limited treatment options to address their symptoms and impact on their social life. The FDA's expanded approval of GEMTESA is an important milestone for the men with unresolved symptoms of OAB while being treated for BPH, which underscores our urgency to deliver for those affected by conditions with unmet need."