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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

Saturday, June 14, 2008 General News J E 4
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RESEARCH TRIANGLE PARK, N.C., June 13 GlaxoSmithKline (NYSE: GSK) today announced the approval of Requip(R) XL(TM)(ropinirole extended-release tablets) in the U.S. for the treatment of thesigns and symptoms of idiopathic Parkinson's disease. Requip XL is the firstand only oral once-daily non-ergot dopamine agonist indicated for Parkinson'sdisease. The product should be available in pharmacies in mid-July 2008.

Patients with Parkinson's disease may experience what is commonly known as"off" time when their medication wears off and their symptoms return.Symptoms such as slowness of movement, tremor, and rigidity can be problematicfor these patients, causing simple activities and movement to becomedifficult. Results from a pivotal efficacy and safety trial showed thatadding Requip XL to patients' existing levodopa (l-dopa) therapy reduced theamount of "off" time experienced by patients with Parkinson's disease by 2.1hours per day on average, compared to baseline. Specifically, comparing theexperience of the group treated with Requip XL versus the placebo group, theadjusted mean difference in the reduction of "off" time was -1.7 hours, whichwas statistically significant.

"Many patients require multiple doses of one or more medications tocontrol their Parkinson's symptoms, which makes taking their medicinescorrectly and at the right times challenging. In addition, patients withParkinson's disease may have trouble completing routine activities of dailyliving and self-care," said clinical investigator Rajesh Pahwa, M.D.,professor of Neurology and director of the Parkinson's Disease and MovementDisorder Center at the University of Kansas Medical Center in Kansas City."Requip XL provides continuous delivery of ropinirole over 24 hours to providesmoother blood levels without the peaks and troughs that multiple daily dosestypically deliver. It is an important once-daily treatment option forpatients with Parkinson's disease."

Requip XL is an extended-release, once-daily tablet formulation that usesSkyePharma PLC's (LSE: SKP) patented GEOMATRIX(TM) technology. Thisinnovative tri-layer formulation allows for continuous delivery of ropiniroleover 24 hours to provide smooth blood levels. Requip XL offers physicians andpatients a simple titration regimen; it also offers a convenient, once-dailydosing schedule compared to other oral dopamine agonists, which are dosedmultiple times a day.

Clinical Study

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

Once-daily use of Requip XL was generally well tolerated in the study.The withdrawal rate due to adverse reactions was low and similar betweengroups (6 percent Requip XL vs. 5 percent placebo). The most common adversereactions reported in patients taking Requip XL compared to placebo weredyskinesia (13 percent vs. 3 percent), nausea (11 percent vs. 4 percent),dizziness (8 percent vs. 3 percent), hallucination (7 percent vs. 3 percent),somnolence (7 percent vs. 4 percent), abdominal pain/discomfort (6 percent vs.3 percent) and orthostatic hypotension (5 percent vs. 1 percent).

A Progressively Disabling Disease

Parkinson's disease is a chronic, progressive, and often disab
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