FDA Approves Drug Combo for Overactive Bladder

The US Food and Drug Administration (FDA) has approved a supplemental new drug application for the use of Myrbetriq (mirabegron) in combination with VESIcare (solifenacin succinate) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.

The approval was granted following the success of the SYNERGY I (n = 6991), SYNERGY II (n = 2084) and BESIDE (n = 2174) studies, which demonstrated the safety and efficacy of combination therapy with mirabegron and solifenacin succinate compared with each drug as monotherapy or placebo.

Both miragebron and solifenacin succinate are already FDA-approved as monotherapies for OAB.

"OAB patients may have symptoms that are not fully managed with their current treatment," said Carol Schermer, MD, MPH, senior medical director of urology at Astellas Pharma Inc, in a press 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."

—Christina Vogt

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