Urovant Sciences, a biopharmaceutical company under Sumitomo Dainippon Pharma, has announced the U.S. commercial launch of GEMTESA® (vibegron) 75 mg tablets. This beta-3 (β3) adrenergic receptor agonist is indicated for the treatment of overactive bladder (OAB) in adults, addressing symptoms such as urge urinary incontinence (UUI), urgency, and urinary frequency.
A New Option for OAB Management
GEMTESA's launch marks a significant advancement in OAB treatment, being the first new oral branded medication for OAB to reach the market in nearly ten years. Jim Robinson, president and CEO of Urovant, emphasized the importance of this milestone for both the company and the urology community. The drug aims to relax the detrusor bladder muscle, increasing bladder capacity and reducing OAB symptoms.
Clinical Efficacy and Safety Profile
Approved by the FDA in December 2020, GEMTESA distinguishes itself as the first and only β3 agonist with urgency data and without a blood pressure warning on its label. Clinical trials demonstrated significant reductions in all three key OAB symptoms compared to placebo at Week 12. Furthermore, studies suggest no association between the beta-3 agonist class and cognitive decline, a notable advantage for patients concerned about long-term cognitive health.
Addressing a Significant Unmet Need
Overactive bladder affects approximately 30 million Americans, significantly impacting their daily lives. Symptoms include urinary urgency, urgency incontinence, frequent urination (eight or more times in 24 hours), and nocturia (waking up more than two times per night to urinate). GEMTESA offers a new approach to managing these symptoms by targeting the bladder muscle directly.
Dosing and Administration
GEMTESA is administered orally once daily at a dose of 75 mg. It is crucial for healthcare providers to evaluate patients for other potential causes of frequent urination before initiating treatment. Patients with significant bladder outlet obstruction should be monitored closely due to an increased risk of urinary retention.
Safety Considerations
Common side effects associated with GEMTESA include headache, urinary tract infection, nasal congestion, sore throat, diarrhea, nausea, and upper respiratory tract infection. Patients should be advised to seek immediate medical attention if they experience an inability to empty their bladder.
Urovant's Commitment
Urovant Sciences is dedicated to developing and commercializing innovative therapies for urologic conditions. GEMTESA is also under evaluation for OAB treatment in men with benign prostatic hyperplasia (OAB+BPH). The company's pipeline includes URO-902, a gene therapy for OAB patients who have not responded to oral medications.
