Astellas Pharma has gained FDA approval for Myrbetriq (mirabegron) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
Myrbetriq is a once daily oral beta-3 adrenergic agonist discovered and developed by Astellas.
Astellas Pharma Global Development president Steven Ryder said, "Myrbetriq is the first oral OAB treatment with a distinct mechanism of action since the launch of anticholinergic agents 30 years ago."
Myrbetriq 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.
Myrbetriq is expected to be available in pharmacies, in 25mg and 50mg tablets, in the fourth quarter of 2012.
The product was approved in July 2011, in Japan and regulatory applications are under review in many other countries.
