FDA Approves Requip for Restless Leg Syndrome

The Food and Drug Administration has approved Requip (ropinirole) to treat moderate to severe Restless Legs Syndrome (RLS). The drug was first approved for Parkinson's disease in 1997.

Restless Legs Syndrome is a condition that affects about ten percent of the population. The disorder is characterized by an urge to move the legs, usually accompanied by or caused by uncomfortable leg sensations. For most people with the condition, symptoms begin or worsen during periods of rest or inactivity and are partially or totally relieved by movement. Symptoms typically worsen or occur only in the evening or at night, and can disturb sleep.

Requip 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.

Health Solutions From Our Sponsors