|
|
FDA Approves Ropinirole for Restless Legs Syndrome
May 6, 2005, 12:36, Reviewed by: Dr.
|
|
All three studies demonstrated a statistically significant difference between the treatment group receiving Requip and the group receiving placebo.
|
By Akanksha, Pharmacology Correspondent,
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.
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.
Syncope (fainting) or symptomatic hypotension (low blood pressure) may occur, particularly during initial treatment or dosing. 
- U.S. Food and Drug Administration (FDA)
FDA
For any corrections of factual information, to contact the editors or to send
any medical news or health news press releases, use
feedback form
Top of Page
|
|
|
|
