Requip XL approved by FDA
FDA approves extended-release formulation of ropinirole for Parkinson's disease.
GlaxoSmithKline (GSK) has announced the Food & Drug Administration approval of ropinirole extended-release tablets (Requip XL) for the once-daily treatment of Parkinson’s disease. Efficacy of the new tablet, which utilizes SkyePharma’s Geomatrix technology (a tri-layer continuous-release delivery mechanism), was proven in the EASE-PD Adjunct study of 393 patients who received treatment with l-dopa plus either the new product or placebo. Results showed Requip XL significantly reduced “off” time by an average of 2.1 hours per day compared with 0.4 hours for placebo. The immediate-release version of ropinirole (Requip, GSK) is indicated for the treatment of moderate to severe primary restless legs syndrome. According to GSK, Requip XL should be available in pharmacies by mid-July 2008.
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