WASHINGTON -- The FDA has approved mirabegron (Myrbetriq) for the treatment of overactive bladder in adults.
The drug is an extended-release tablet that relaxes bladder muscles during filling to improve storage capacity.
Mirabegron's safety and efficacy were established in three clinical trials of 4,116 patients with overactive bladder. Patients were randomized to 25, 50, or 100 mg doses, or placebo, once daily for 12 weeks.
In those in the 25 and 50 mg groups, the drugs effectively reduced the number of times they urinated and had wetting accidents in a day, an FDA statement said. Those in the 50 mg group also expelled more urine "demonstrating the drug's effectiveness in improving the storage capacity of the bladder."
An FDA advisory committee voted 7-4, with one abstention, in April that the drug's benefit outweighed its risks, but claimed it offered only a "marginal" benefit over placebo.
Adverse events seen during the clinical trials included hypertension, nasopharyngitis, urinary tract infection, constipation, fatigue, tachycardia, and abdominal pain.
The drug is not recommended for patients with uncontrolled hypertension, end-stage kidney disease, or severe liver impairment, the statement said.
Mirabegron is marketed by Astellas Pharma.