Requip tablets treat symptoms of primary RLS

December 15, 2004

Research Triangle Park, NC (December 15, 2004) - Study results published today in the journal Movement Disorders show that Requipâ(ropinirole HCl) Tablets effectively treats the symptoms of primary Restless Legs Syndrome (RLS) as assessed by improvements in symptoms, over 12 weeks. Improvements were seen as early as one week. The study of 267 patients, one of the largest placebo-controlled trials of a treatment for RLS conducted to-date, also showed significant improvements in sleep and quality of life in RLS patients taking Requip versus placebo. Requip is under review by the U.S. Food and Drug Administration (FDA) for the treatment of the signs and symptoms of primary RLS. There is no FDA-approved treatment for RLS in the United States.

"Patients with Restless Legs Syndrome often suffer from chronic sleep problems as a result of an urge to move their legs, often accompanied by discomfort or unpleasant feelings in their legs. This sleep disruption is one of the most distressing aspects of the condition and can greatly impact quality of life," said Arthur S. Walters, M.D., Director of the Center for Sleep Disorders Treatment, Research and Education at the New Jersey Neuroscience Institute at John F. Kennedy Medical Center. "These study results are encouraging because they provide evidence that Requip significantly improved symptoms of RLS at one week. Patients experienced improvements in sleep and quality of life."

Restless Legs Syndrome is a common and disruptive neurological condition characterized by an irresistible urge to move the legs and by uncomfortable or sometimes painful sensations in the legs often described as creeping-crawling, burning or twitching. Symptoms of RLS generally occur at rest, such as when sitting, lying or sleeping, and are temporarily relieved by movement. These symptoms can significantly disrupt a patient's sleep and daily activities. People with RLS often have difficulty falling and staying asleep and can feel less alert during the day. RLS sufferers may also have difficulty with activities that require prolonged sitting such as movies, long car rides or airline flights. When evaluating patients' symptoms of RLS, it is important for healthcare providers to rule out other underlying conditions that are associated with secondary RLS symptoms, such as iron deficiency, pregnancy and renal failure.

Significant and Sustained Relief from RLS Symptoms
Patients in this trial experienced significant improvement in their symptoms at one week of treatment with Requip, continuing through week 12. In total, 267 patients ages 18-79, with moderate-to-severe primary RLS, were randomized to Requip (0.25-4.0 mg/day) or placebo, 1-3 hours before bedtime. The primary endpoint was the change in International RLS Rating Scale (IRLS Scale) score at week 12. Improvements were significantly better for Requip than placebo on the IRLS Scale (-11.2 vs. -8.7; p = 0.0197).

Key secondary endpoints were the percentage of patients showing significant improvement on the Clinical Global Impression-Improvement (CGI-I) scale at week 12, and changes in their IRLS Scale and CGI-I scale scores at week one. At week 12, significantly more patients treated with Requip (78/131, 59.5 percent) responded "much improved" or "very much improved" on the CGI-I scale compared with those treated with placebo (53/134, 39.6 percent; p = 0.001).

In addition, patients taking Requip showed significant improvement from baseline in the IRLS Scale score at the end of week one (-8.4 vs. -4.8; p< 0.0001). On the CGI-I scale, more patients taking Requip (48/131, 36.6 percent) than those taking placebo (22/134, 16.4 percent) responded "much improved" or "very much improved" after one week (p = 0.0003).

Requip® Improves Sleep and Quality of Life
Patients taking Requip showed significant improvements in sleep as measured in all four domains of the Medical Outcomes Study (MOS) sleep scale at week 12 (somnolence, p = 0.0043; sleep disturbance, p< 0.0001; sleep adequacy, p< 0.0001; sleep quantity, p= 0.0097). According to the study authors, this means patients taking Requip slept more soundly (with less disturbance), for a longer time, perceived their sleep adequacy was improved and were less sleepy during the daytime than those taking placebo.

There were also improvements in patients' quality of life (QoL), assessed using the disease-specific RLS QoL questionnaire. At week 12, the overall life-impact score showed a significant difference in favor of Requip (increased 17.4 points) over placebo (increased 12.9 points; p = 0.0263). Using a general QoL scale (SF-36 Health Survey), there was a significant difference in favor of Requip for mental-health, social functioning and vitality. Values for physical functioning, bodily pain, role-physical, role-emotional and general health were not significantly different between the two treatment groups.

"I suffer from Restless Legs Syndrome and found that getting to sleep was difficult because I needed to move my legs in order to relieve the unpleasant sensations in the legs," stated study participant Kim McLawhon. "Staying asleep was also challenging because my leg movements disturbed my sleep and I never felt rested in the morning. But being in the clinical trial and taking Requip helped to control my symptoms so that I got more sleep at night."

During treatment over a twelve-week period and over the dose range of 0.25 - 4 mg/day, the most commonly reported adverse events of Requip (n=131) versus placebo (n=136) were nausea (39.7 percent vs. 8.1 percent), headache (22.1 percent vs. 25.7 percent), fatigue (15.3 percent vs. 6.6 percent), dizziness (15.3 percent vs. 4.4 percent) and vomiting (12.2 percent vs. 2.2 percent).

About Requip®
Requip is a second-generation non-ergoline dopamine agonist that directly stimulates dopamine receptors in the brain. While the exact cause of primary RLS is unknown, doctors believe it is caused by a lack of dopamine, a chemical that carries the signals between the nerve cells that control movement.

Requip is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease and is generally well-tolerated in this population. In placebo-controlled studies for early treatment in this patient population, the most commonly reported side effects for Requip versus placebo were nausea (60 percent versus 22 percent), dizziness (40 percent versus 22 percent) and somnolence (40 percent versus 6 percent). Patients are advised to talk to their doctor about whether they have the potential to develop the sedating effects associated with Requip, which include somnolence, and the possibility of falling asleep while engaged in activities of daily living, including operation of a motor vehicle. Fainting or low blood pressure may occur during initial treatment or with an increase in dose. Hallucinations may occur at anytime during treatment. Requip may potentiate the side effects of L-dopa and may cause and/or exacerbate pre-existing dyskinesias.

About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. Please consult full prescribing information for Requip, available at www.Requip.com. For more information on GlaxoSmithKline, call 1-888-825-5249 or visit www.gsk.com.
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Cohn & Wolfe

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