Approval sought for new overactive bladder treatment
Posted Sep 08 2011 6:15pm
Issue Codes Incontinence Accessories and Hygiene
Pharmaceutical company Astellas Pharma has moved a step closer to marketing its new therapy for overactive bladder – a condition characterised by urgency, urinary frequency and urge urinary incontinence .
Astellas has submitted a new drug application and market authorisation application to both the US Food and Drug Administration and the European Medicines Agency for mirabegron.
If approved, the drug could soon be available to patients in the US and Europe, potentially reducing their need for disposable incontinence pads, such as Cottons Comforts Pantyliners .
The first-in-class medicine is a once-daily oral therapy known as a selective B3-adrenoceptor agonist.
It is designed to activate receptors on the smooth muscle of the bladder, thereby relaxing the bladder and reducing urgency and urinary frequency.
Results from phase-III clinical trials in both the US and Europe indicate that mirabegron may help to relieve symptoms of overactive bladder, including adult incontinence .
Mirabegron is already approved in Japan, where it is marketed as Betanis.