FDA approves Myrbetriq for overactive bladder
Friday, June 29, 2012
The FDA has approved Astellas Pharma’s Myrbetriq (mirabegron) to treat adults with overactive bladder.
An extended-release tablet taken once daily, Myrbetriq improves the storage capacity of the bladder by relaxing the bladder muscle during filling. Symptoms of overactive bladder include the need to urinate too often (urinary frequency), the need to urinate immediately (urinary urgency) and the involuntary leakage of urine as a result of the need to urinate immediately (urge urinary incontinence).
“An estimated 33 million Americans suffer from overactive bladder, which is uncomfortable, disrupting and potentially serious,” said Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.
Myrbetriq’s safety and efficacy were demonstrated in three double-blind, placebo-controlled, multicenter clinical trials. A total of 4,116 patients with overactive bladder were randomly assigned to take Myrbetriq at doses of 25mg, 50 mg, 100 mg or a placebo once daily for 12 weeks.
Results showed that Myrbetriq 25mg and 50mg effectively reduced the number of times a patient urinated and the number of times a patient had wetting accidents during a 24-hour period. Patients taking Myrbetriq 50mg also expelled a greater amount of urine, demonstrating the drug’s effectiveness in improving the storage capacity of the bladder.
The most common adverse events observed in the trials were increased blood pressure, common cold-like symptoms (nasopharyngitis), urinary tract infection, constipation, fatigue, elevated heart rate (tachycardia) and abdominal pain.
Myrbetriq is not recommended for use in those with severe uncontrolled high blood pressure, end stage kidney disease or severe liver impairment.