A supplemental New Drug Application (sNDA) has been submitted by Astellas Pharma to the Food and Drug Administration (FDA) for the combination of mirabegron and solifenacin succinate 5mg in the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Both mirabegron (Myrbetriq) and solifenacin succinate (Vesicare) are approved as monotherapy for the treatment of OAB.
The sNDA submission is based on data from the Phase 3 SYNERGY I, SYNERGY II and BESIDE studies. These studies, which included more than 5,000 patients with OAB, evaluated combination therapy with mirabegron and solifenacin succinate compared with each drug as monotherapy and placebo.
Mirabegron is an agonist of the human beta-3 adrenergic receptor. It relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 adrenergic receptors which increases bladder capacity.
Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle.
“We look forward to FDA’s review of our application for a potential new treatment option for the millions of people living with OAB,” said Bernhardt Zeiher, MD, president of Development at Astellas.
For more information visit Astellas.com.