Myrbetriq (mirabegron) Approved for Overactive Bladder

New Drugs , News / September 30, 2016

The FDA today approved Myrbetriq (mirabegron) for the treatment of adults with overactive bladder, a condition in which the bladder muscle cannot be controlled, squeezes too often, or squeezes without warning.

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).

The safety and efficacy of Myrbetriq 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 25, 50 and 100 mg, or a placebo once daily for 12 weeks.

Results showed that a 25-50 mg dose of Myrbetriq effectively reduced the number of times a patient urinated and the number of times a patient suffered wetting accidents during a 24-hour period. Patients taking Myrbetriq 50 mg also expelled a greater amount of urine, demonstrating the drug’s effectiveness in improving the storage capacity of the bladder.

The most common side effects observed in trials with Myrbetriq were increased blood pressure, common cold-like smyptoms (nasopharyngitis), urinary tract infection, constipation, fatigue, 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.

Myrbetriq is marketed by Astellas Pharma US, Inc. of Northbrook, Ill.

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