U.S. FDA Approves Requip(R) XL(TM), the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson... ( Requip XL Improved Symptoms in Pat...)

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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

Requip XL Improved Symptoms in Patients Not Optimally Controlled with Levodopa and Reduced Patients' "Off" Time by Nearly Two Hours Per Day

RESEARCH TRIANGLE PARK, N.C., June 13 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today announced the approval of Requip(R) XL(TM) (ropinirole extended-release tablets) in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Requip XL is the first and only oral once-daily non-ergot dopamine agonist indicated for Parkinson's disease. 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 problematic for these patients, causing simple activities and movement to become difficult. Results from a pivotal efficacy and safety trial showed that adding Requip XL 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 Requip XL versus the placebo group, the adjusted mean difference in the reduction of "off" time was -1.7 hours, which was statistically significant.

"Many patients require multiple doses of one or more medications to control their Parkinson's symptoms, which makes taking their medicines correctly and at the right times challenging. In addition, patients with Parkinson's disease may have trouble completing routine activities of daily living and self-care," said clinical investigator Rajesh Pahwa, M.D., professor of Neurology
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