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06-18-2008, 07:32 PM | #1 | |||
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GlaxoSmithKline today announced the approval of Requip® XL™(ropinirole extended-release tablets) in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. It is the first and only oral once-daily non-ergot dopamine agonist indicated for Parkinson’s disease. The product should be available in U.S. 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 problematic for these patients, causing simple activities and movement to become difficult. Results from a pivotal efficacy and safety trial showed that adding extended-release ropinirole to patients’ existing levodopa (l-dopa) therapy reduced the amount of “off” time experienced by patients with Parkinson’s disease by 2.1 hours per day on average, compared to baseline. Specifically, comparing the experience of the group treated with extended-release ropinirole versus the placebo group, the adjusted mean difference in the reduction of “off” time was -1.7 hours, which was statistically significant. http://www.gsk.com/media/pressreleas...ease_10064.htm
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