Sumitomo Pharma Co., Ltd. companies, Sumitomo Pharma America Inc. (SMPA) and Sumitomo Pharma Switzerland (SMPS), announced that the Phase 3 UO-901-3005 clinical study of vibegron (GEMTESA®?), a beta-3 adrenergic receptor (b3) agonist, dosed once-daily (75 mg), which is being investigated in men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH), met its co-primary endpoints at Week 12 compared to placebo. The co-primary endpoints include both change from baseline in the average number of micturition (urination) episodes per day and change from baseline in The average number of urgency episodes (the sudden urge to urinate that is difficult to control) per day. 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 works by selectively targeting b3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity. In China, vibegron is currently under investigation in a Phase 3 clinical study for the treatment of OAB. Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts invol voluntarily.

Symptoms may include urinary urgency (the sudden urge to urinating that is difficult to control), urgency incontinence (un intentional loss of urine immediately after an urgent need to urinate), and frequent urination (usually eight or more times in 24 hours). Benign Prostatic Hyperplasia (BPH) is a condition in men in which the prostate gland is enlarged. About 60% of men with BPH are treated for lower urinary tract symptoms (LUTS).

LUTS can be divided into storage, voiding, and postmicturition symptoms. Over half of men with BPH report storage symptoms and about a quarter report voiding symptoms. This suggests that many men with a diagnosis of BPH may have overactive bladder. Many men who are treated for symptoms are assumed to have an obstruction in the bladder caused by an enlarged prostate.3,4 About half of all men between ages 51 and 60 have BPH and up to 90% of men over age 80 are living with the condition.