New drug gets approval for overactive bladder

US Food and Drug Administration (FDA) has approved a new drug which may bring relief to patients who suffer from an overactive bladder, when other medications fail to treat the problem. Mirabegron is an extended-release tablet taken daily that improves the storage capacity of the bladder by relaxing the bladder muscle during filling. The approval is based on three trials involving 4116 patients. Results showed that Myrbetriq 25mg and 50mg effectively reduced the number of times a patient urinated and the number of times a patient had wetting accidents during a 24-hour period.

Myrbetriq is a once daily oral beta-3 adrenergic agonist developed by Astellas. It has been extensively studied in more than 10,000 individuals over 10 years. Myrbetriq uses a distinct mechanism of action and 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. The recommended starting dose for Myrbetriq is 25 mg once daily with or without food. Myrbetriq 25 mg is effective within eight weeks; based on individual efficacy and tolerability, the dose may be increased to 50 mg once daily.

Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research said, “An estimated 33 million Americans suffer from overactive bladder, which is uncomfortable, disrupting and potentially serious. Today’s approval provides a new treatment option for patients with this debilitating condition.”

The most common side effects observed in the trials were increased blood pressure, common cold-like symptoms (nasopharyngitis), urinary tract infection, constipation, fatigue, elevated heart rate (tachycardia), and abdominal pain. According to FDA, Myrbetriq is not recommended for use in those with severe uncontrolled high blood pressure, end-stage kidney disease or severe liver impairment.

We will keep our readers posted as and when this product becomes available in the UK. If you are suffering from bladder weakness or worried because of urination problems, Medical Specialists offers Tena for men, a protector which you can wear discreetly and get on with your day to day life. We also have Flomax, which can be taken if you are suffering from annoying bladder (pee) problems. Visit our embarrassing conditions page for further information.