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FDA NEWS RELEASE

For Immediate Release: June 28, 2012
Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Myrbetriq for overactive bladder

The U.S. Food and Drug Administration today approved Myrbetriq (mirabegron) to treat 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).

“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. “Today’s approval provides a new treatment option for patients with this debilitating condition.”

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 25 milligrams, 50 mg, 100 mg, or a placebo once daily for 12 weeks.

Results showed that Myrbetriq 25 mg and 50 mg 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 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 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.

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

For more information:

FDA Approved Drugs: Questions and Answers
 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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