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Requip (Ropinirole HCl) Tablets Significantly Improve Symptoms of Restless Legs Syndrome

Largest U.S. Study in Moderate-to-Severe Primary RLS Published in Mayo Clinic Proceedings

RESEARCH TRIANGLE PARK, NC -- January 3, 2006 -- Data published in the January issue of Mayo Clinic Proceedings show that Requip(R) (ropinirole HCl) Tablets significantly improve Restless Legs Syndrome (RLS) symptoms.

The study, entitled TREAT RLS US (Therapy with Ropinirole, Efficacy and Tolerability in Restless Legs Syndrome), is the largest U.S. study to date of the treatment of RLS. The TREAT RLS US results support previous studies with Requip, the first and only FDA-approved treatment for moderate-to-severe primary RLS.

RLS is a chronic and disruptive neurological condition that encompasses a range of severity that includes mild, moderate and severe symptoms, and affects approximately one in ten adults in the U.S.

"The consistency of positive data across several key clinical trials, including these latest results from the largest study of the treatment of RLS, further supports Requip as an effective treatment for relieving the uncomfortable symptoms of RLS," said Richard K. Bogan, MD, Assistant Clinical Professor of Medicine, USC School of Medicine, Columbia, SC, and lead author of the TREAT RLS US study in Mayo Clinic Proceedings. "RLS patients should be encouraged by the results of this latest study with Requip, which demonstrate relief with Requip and the onset of symptom improvement after two nights."

About the TREAT RLS US Study
The 12-week study included 47 centers across the U.S., and was a double- blind, randomized, placebo-controlled study of 380 adult patients (ages 18-79) with primary RLS symptoms 15 or more times in the last month.

In the study, researchers observed statistically significant improvements in RLS symptoms in favor of Requip versus placebo according to two validated, subjective questionnaires called the International Restless Legs Syndrome (IRLS) Rating Scale and the Clinical Global Impression - Improvement (CGI-I) Scale.

The study met the primary endpoint, showing that Requip decreased RLS symptom severity according to the IRLS total score when measured at Week 12 compared to placebo. Using the same scale, patients taking Requip reported significant improvement in symptoms after two nights of treatment versus placebo.

The study met secondary endpoints, with researchers observing similar improvements in RLS symptoms after two nights and at Weeks 1 and 12 using the CGI-I scale. Patients in the study were given once-daily flexible doses of either Requip (0.25-4.0 mg/day; mean dose 2.1 mg/day) or placebo, one to three hours before bedtime. The initial dose of ropinirole or matched placebo could be titrated as needed and as tolerated.

In TREAT RLS US, the most common adverse events reported in the ropinirole group (n=187) versus placebo (n=193) were nausea (43% versus 8%), headache (17% versus 19%), somnolence (13% versus 7%), and nasopharyngitis (11% versus 12%). The withdrawal rate due to adverse events was low and similar between the two groups (ropinirole 3% versus placebo 4%).

About Requip(R)
When approved in May 2005 for the treatment of moderate-to-severe primary RLS, Requip became the first and only FDA-approved treatment for RLS of any type or severity. Requip is a second-generation dopamine agonist that is available in a variety of strengths for flexible dosing (up to 4 mg/day for RLS patients) to meet individual patients' needs. Requip has the largest published program of clinical trials in RLS to date.

Requip directly activates dopamine receptors in the brain. Although its exact cause is unknown, researchers believe that the underlying cause of RLS may be related to dopamine, a chemical that carries the signals between nerve cells that control body movement. When the dopamine system does not function properly, it may upset the normal communication of these signals.

Prescription Requip Tablets are not for everyone. Requip may cause you to fall asleep or feel very sleepy while doing normal activities such as driving; or to faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down. If you experience these problems, talk with your doctor. Tell your doctor if you drink alcohol or are taking other medicines that make you drowsy. Side effects include nausea, drowsiness, vomiting, and dizziness. Most patients were not bothered enough to stop taking Requip.

About RLS
Identified in the early 1940's by neurologist Dr. Karl Ekbom, RLS is characterized by a compelling urge to move the legs and by uncomfortable or sometimes painful sensations in the legs often described as creeping-crawling, tingling, pulling or tightening. 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 asleep and can feel tired during the day.


SOURCE: GlaxoSmithKline

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