FDA Approves Myrbetriq Combo Treatment for Overactive Bladder

The Food and Drug Administration (FDA) has approved Myrbetriq (mirabegron extended-release tablets; Astellas) in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

In clinical trials, the combination of Myrbetriq + solifenacin succinate was associated with greater improvements in the number of incontinence episodes per 24 hours (primary endpoint), the number of micturitions per 24 hours (primary endpoint), and the volume voided per micturition (secondary endpoint) compared to placebo or to individual active components. Long-term data also demonstrated that the effects of combination treatment were maintained throughout a 1-year treatment period.

The most commonly reported adverse reactions in patients treated with the combination therapy were dry mouth, urinary tract infection, constipation, and tachycardia. The prescribing information also includes a warning about urinary retention which has been reported to occur in patients with bladder outlet obstruction and in those taking muscarinic antagonist medications such as solifenacin succinate.

Myrbetriq, a beta-3 adrengeric agonist, is also approved as monotherapy for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency. The extended-release tablets are available in 25mg and 50mg dosage strengths in 30- and 90-count bottles.

For more information visit Myrbetriqhcp.com.