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U.S. FDA Approves Requip(R) XL(TM), the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson's Disease
Date:6/13/2008

and director of the Parkinson's Disease and Movement Disorder Center at the University of Kansas Medical Center in Kansas City. "Requip XL provides continuous delivery of ropinirole over 24 hours to provide smoother blood levels without the peaks and troughs that multiple daily doses typically deliver. It is an important once-daily treatment option for patients with Parkinson's disease."

Requip XL is an extended-release, once-daily tablet formulation that uses SkyePharma PLC's (LSE: SKP) patented GEOMATRIX(TM) technology. This innovative tri-layer formulation allows for continuous delivery of ropinirole over 24 hours to provide smooth blood levels. Requip XL offers physicians and patients a simple titration regimen; it also offers a convenient, once-daily dosing schedule compared to other oral dopamine agonists, which are dosed multiple times a day.

Clinical Study

FDA approval was based primarily on results from the EASE-PD (Efficacy And Safety Evaluation in Parkinson Disease) Adjunct Study, a multi-center, double-blind, placebo-controlled study conducted in patients with idiopathic Parkinson's disease not adequately controlled with l-dopa. A total of 393 patients in the study were randomized to receive either Requip XL (n=202) or placebo (n=191) once daily for 24 weeks in addition to l-dopa. The study's primary endpoint was the mean change from baseline at week 24 in awake time spent "off," which was measured via patient diaries. Results from the study showed that Requip XL significantly reduced "off" time by an average of 2.1 hours per day from baseline, compared to a reduction of 0.4 hours per day for placebo.

Once-daily use of Requip XL was generally well tolerated in the study. The withdrawal rate due to adverse reactions was low and similar between groups (6 percent Requip XL vs. 5 percent placebo). The most common adverse reactions reported in patients taking Requip XL compared to placebo were dyskinesia (13 percent vs. 3 percent),
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SOURCE GlaxoSmithKline
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