Astellas announced that the FDA has approved Myrbetriq (mirabegron) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

The approval of Myrbetriq was based on safety and efficacy data from three placebo-controlled Phase 3 studies, in which treatment with Myrbetriq 25mg and 50mg resulted in statistically significant improvement in efficacy parameters of incontinence episodes and number of urinations per 24 hours. The population included both naive patients who had not received prior antimuscarinic pharmacotherapy for OAB (48%) and those who had received prior antimuscarinic pharmacotherapy for OAB (52%).

Mirabegron is a potent and selective beta-3 adrenoceptor agonist. It activates beta-3 adrenoceptor on the detrusor muscle of the bladder to facilitate filling of the bladder and storage of urine.

Myrbetriq extended-release tablets will be available from Astellas in 25mg and 50mg dosage strengths in the fourth quarter of 2012.

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