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FDA Approves New Drug to Treat Overactive Bladder Symptoms

Susan Jaffe

Posted: 06/28/2012

June 28, 2012 (Washington, DC) — A new drug approved today by the US Food and Drug Administration (FDA) may bring relief to patients who suffer from an overactive bladder, when other medications fail to treat the problem.

Mirabegron (Myrbetriq, Astellas Pharma) is an extended-release tablet taken daily that relaxes the bladder muscle and improves the bladder’s storage capacity. When tested during 3 double-blind, placebo-controlled clinical trials, 25- and 50-mg doses of mirabegron improved bladder control and reduced urinary incontinence, urgency, and frequency, according to an FDA statement.

“An estimated 33 million Americans suffer from overactive bladder, which is uncomfortable, disrupting and potentially serious,” said Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides a new treatment option for patients with this debilitating condition.”

According to the FDA, common adverse effects that occurred during the clinical trials were increased blood pressure, symptoms of a common cold, and urinary tract infection, constipation, fatigue, elevated heart rate (tachycardia), and abdominal pain. The drug is not recommended for patients with severe uncontrolled high blood pressure, end-stage kidney disease, or severe liver impairment.

The drug was approved in April by a 7-to-4 vote by the FDA’s Advisory Committee for Reproductive Health Drugs, and is manufactured by Astellas Pharma, based in Northbrook, Illinois.

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