Thread: Requip XR...GLK filed for approval with the FDA
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Old 04-14-2007, 06:32 PM
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SkyePharma Submits New Version of Requip for Approval

Posted on: Friday, 13 April 2007, 12:00 CDT
http://www.redorbit.com/news/health/...ource=r_health

The FDA has accepted SkyePharma's application for a new extended release version of Requip for the treatment of Parkinson's disease.

SkyePharma said Requip extended release has been designed to provide a steady rate of absorption in the body to help reduce blood plasma fluctuations over 24 hours. The drug uses SkyePharma's GeoMatrix technology and has been designed to be given once daily and to have a simpler and faster titration schedule. The drug is manufactured by GlaxoSmithKline.

GlaxoSmithKline previously reported positive results from a safety and efficacy evaluation of Requip. In that study, Requip XL 24-hour once daily was added to Parkinson's patients' existing levodopa therapy which significantly reduced "off" time by an average of more than 2 hours per day when compared with baseline prior to treatment.

If approved for Parkinson's disease, future sales of Requip will generate low mid-single digit royalties for SkyePharma.

Commenting on the announcement, Frank Condella, CEO of SkyePharma, said: "Dopamine agonists are increasingly recommended by doctors as a first-line therapy for patients suffering from Parkinson's disease and this new, once-daily version of Requip could deliver significant benefits for these patients and may improve compliance."

Source: Datamonitor
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