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FDA Approves Drug for Restless Legs Syndrome

May 6, 2005

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The Food and Drug Administration (FDA) has approved Requip (ropinirole) to treat moderate to severe Restless Legs Syndrome (RLS), a condition that affects about ten percent of the population. The drug has been used to treat Parkinson' s disease since 1997.

Restless Legs Syndrome is characterized by an urge to move the legs, usually accompanied by uncomfortable sensations. For most people with the condition, symptoms begin or worsen during periods of rest or inactivity and are relieved by movement. Symptoms typically worsen or occur only in the evening or at night, and can disturb sleep.

Requip, manufactured by GlaxoSmithKline, was found to be effective for RLS in three randomized, double-blind placebo controlled studies in adults diagnosed with moderate to severe RLS.

The studies measured effectiveness of the drug using the International Restless Leg Syndrome Scale, a patient rated scale that measures different aspects of RLS including severity of muscle movement and discomfort, sleep disturbance, mood and overall effect on quality of life.

The Clinical Global Impression-Global Improvement scale was also used. This is an investigator rated scoring of improvement following treatment. All three studies demonstrated a statistically significant difference between the treatment group receiving Requip and the group receiving placebo.

Common side effects of Requip reported in clinical trials include nausea, headache, and vomiting. The label for the drug will also include a caution that Requip has been associated with sedating effects, including somnolence (sleepiness), 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 also occur, particularly during initial treatment or dosing.

Woman are twice as likely as men to be affected by the condition, which can worsen with age. After age 50, many people with restless legs syndrome have daily symptoms and significant sleep problems.

The drug is manufactured by GlaxoSmithKline.

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