FDA Approves Gemtesa (Vibegron) for Overactive Bladder in Men with BPH
Key Insights
The FDA has approved Gemtesa (vibegron) for men with overactive bladder (search) (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (search) (BPH).
Gemtesa is the first and only beta-3 adrenergic receptor agonist approved for OAB in men being treated for BPH, addressing a significant unmet need.
Approval was based on a Phase 3 trial demonstrating significant reductions in micturition and urgency episodes compared to placebo.
Sumitomo Pharma America (search) announced that the U.S. Food and Drug Administration (FDA) has approved Gemtesa (vibegron) for the treatment of overactive bladder (search) (OAB) symptoms, such as urge urinary incontinence, urgency, and urinary frequency, in men receiving pharmacological therapy for benign prostatic hyperplasia (search) (BPH). This approval marks Gemtesa as the first and only beta-3 adrenergic receptor agonist approved for this specific patient population.
The approval is based on the results of the URO-901-3005 Phase 3 study, a 24-week trial involving approximately 1,100 men with OAB symptoms who were also receiving pharmacological treatment for BPH. The study compared vibegron to placebo and met all co-primary endpoints at Week 12. These endpoints included statistically significant reductions from baseline in the average number of micturition (urination) episodes per day and the average number of daily urgency episodes compared to placebo.
An additional endpoint showed a reduction in instances of urge urinary incontinence episodes per day at 12 weeks. Adverse reactions, exceeding the placebo rate, reported in ≥2% of patients treated with Gemtesa were hypertension and urinary tract infection.
Clinical Significance
According to Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA, millions of patients suffer from OAB along with existing BPH, and 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.
Dosage and Administration
The recommended dose of Gemtesa is 75 mg taken orally once daily.
Contraindications and Warnings
Gemtesa is contraindicated in patients with known hypersensitivity to vibegron or any of its components. Angioedema has been reported as a hypersensitivity reaction. Urinary retention has been reported in patients taking Gemtesa, particularly in those with bladder outlet obstruction or those taking muscarinic antagonist medications for OAB. Patients should be monitored for signs and symptoms of urinary retention, and Gemtesa should be discontinued if urinary retention develops.
Current Treatment Landscape
Overactive bladder (search) (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). Approximately 33 million U.S. adults experience the bothersome symptoms of OAB.
Benign prostatic hyperplasia (search) (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. 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).