FDA Approves Mirabegron, Solifenacin Combo for OAB

Troy Brown, RN


May 09, 2018

The US Food and Drug Administration (FDA) has approved mirabegron (Myrbetriq, Astellas Pharma) in combination with solifenacin succinate (Vesicare, Astellas Pharma) for the treatment of overactive bladder (OAB) accompanied by symptoms of urge urinary incontinence, urgency, and urinary frequency.

The FDA approved mirabegron, a beta-3 adrenergic agonist, for OAB in June 2012. The FDA approved solifenacin succinate, a muscarinic antagonist, as a monotherapy for the disorder in November 2004.

"OAB patients may have symptoms that are not fully managed with their current treatment," Carol Schermer, MD, MPH, senior medical director, urology, Astellas, said in a news release. "With the FDA approval of Myrbetriq in combination with solifenacin succinate, Astellas is able to offer an additional treatment option to individuals living with symptoms of OAB."

The approval follows consideration of data from three large, global phase 3 trials that compared combination therapy with monotherapy: SYNERGY I, SYNERGY II, and BESIDE.

SYNERGY I (n = 6991) and SYNERGY II (n = 2084) compared mirabegron/solifenacin combination therapy to solifenacin monotherapies. Patients were followed for 12 in SYNERGY I and for 52 weeks in SYNERGY II.

In BESIDE (n = 2174), mirabegron 50 mg in combination with solifenacin 5 mg was superior to solifenacin 5 mg alone for relieving symptoms of incontinence and frequent urination.

Most treatment-emergent adverse events were mild or moderately severe.

The most common adverse effects of mirabegron are increased blood pressure, nasopharyngitis, urinary tract infection, constipation, diarrhea, dizziness, and headache. Common adverse effects of solifenacin are dry mouth, constipation, and indigestion.

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