Overactive Bladder Combination Therapy Gets FDA Supplemental Indication

The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for mirabegron (Mybetriq) as a combination therapy with muscarinic antagonist solifenacin succinate (VESIcare) for the treatment of overactive bladder (OAB) in patients with particular symptoms.

The treatment, from Astellas Pharma, will join this combination regimen to offer an alternative to patients with OAB who suffer from urinary incontinence, urgency, and frequency. Mirabegron is a beta-3 adrenergic agonist that was previously indicated as a monotherapy for the treatment of OAB — as was the accompanying solifenacin succinate.

The sNDA submission and approval was based on combination therapy evaluation from a trio of phase 3 trials. In the SYNERGY I and II studies, more than 9000 patients were administered either mirabegron and solifenacin succinate, monotherapy of either drug, or placebo, to test for safety profile. In the SYNERGY II trial, patients were observed for 52 weeks with adminstrations of 50 mg mirabregon and 5 mg solifenacin succinate 5 mg.

The phase 3b BESIDE study enrolled 2174 patients across 31 countries to test the combination for efficacy, safety, and tolerability of the set-dose regimen versus sole doses of 5 mg and 10 mg solifenacin succinate in patients with OAB who had previous inadequate response to monotherapy.

The need for improved OAB therapies is evidenced by its commonality. According to Astellas, approximately 546 million people will be affected by the condition this year. The condition is characterized by inappropriate signals being sent to the muscles of the bladder that causes contraction prior to the bladder being full, result in strong, sudden, and frequent urges to urinate.

Carol Schermer, MD, MPH, senior medical director of urology at Astellas, acknowledged current therapies’ susceptibility to fail in treating such symptoms.

“OAB patients may have symptoms that are not fully managed with their current treatment," Schermer said in a statment. "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."