GSK/SkyePharma file Requip XL with US FDA

UK drug-delivery specialist SkyePharma says that the US Food and Drug Administration has accepted for filing its partner GlaxoSmithKline's marketing application for Requip (ropinirole HCl) XL, an extended-release tablet formulation of its already-approved Parkinson's disease drug, designed to provide a steady rate of absorption in the body to help cut blood plasma fluctuations over 24 hours.

The immediate-release formulation of the non-ergot dopamine agonist is approved in the USA for the signs and symptoms of idiopathic PD and is administered three times a day. Requip XL 24-Hour uses SkyePharma's proprietary GeoMatrix technology and has been designed to be given once daily and to have a simpler and faster titration schedule. Results from the EASE-PD Adjunct study, published in the April 3 issue of Neurology, found that Requip XL, added to patients's existing levodopa therapy significantly cut off time an average of more than two hours per day compared with baseline prior to treatment.