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CHICAGO (Reuters) May 05 - GlaxoSmithKline Plc said Thursday regulators approved ropinirole (Requip) as the first U.S. treatment for moderate to severe cases of restless legs syndrome. The condition affects 1 in 10 of US adults and is the leading cause of insomnia. Although the cause is unknown, researchers believe it may be related to dopamine. Glaxo said Requip works by stimulating dopamine receptors in the brain. Requip is already an established treatment for Parkinson's disease. In clinical trials for restless legs syndrome, the most common side effects of Requip were nausea, extreme drowsiness, vomiting, dizziness and fatigue. In December, a European Union panel of experts initiated a probe of the drug after concerns surfaced about the product's effectiveness and long-term safety. Called Adartrel in Europe, the drug is sold in a few countries but has not yet received full European approval. GlaxoSmithKline spokeswoman Holly Russell said the drug is still under review, but the company is confident it can address the issues that have been raised. Source: Reuters Health Information Read more here: http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01356.html Requip (Ropinirole HCl) Tablets First and Only Medication Approved by the FDA for the Treatment of Moderate-to-Severe Primary Restless Legs Syndrome (RLS) in Adults RESEARCH TRIANGLE PARK, N.C., May 05, 2005 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) has approved Requip(R) (ropinirole HCl) Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults, GlaxoSmithKline announced today. Requip is the first and only FDA-approved treatment for those patients with moderate-to-severe primary RLS, a chronic and disruptive neurological condition. RLS, which encompasses a range of severity that includes mild, moderate and severe symptoms, affects approximately one in ten adults in the U.S. 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 and staying asleep and can feel less alert during the day. Requip is a second-generation dopamine agonist that directly stimulates 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. "Throughout our clinical research program for Restless Legs Syndrome, we've had the opportunity to speak with many people who suffer from this condition, and we've heard first-hand about how difficult life can be for them," said Chris Viehbacher, President, U.S. Pharmaceuticals, and GlaxoSmithKline. "With the approval of Requip for moderate-to-severe primary RLS, we're proud to be able to offer effective relief to millions of people who live with this condition, many of whom have suffered for years without treatment." "For me, the most difficult aspect of living with RLS has been the urge to move my legs during times when I just want to relax or when I am trying to fall asleep," said Mary Ellen Onufrow. "Several times a week I feel very unpleasant sensations in my legs that are difficult to describe, and the only way to get rid of them is to get up and move around. These symptoms had a significant impact on many aspects of my life including my sleep and my daily activities. Thanks to Requip, my symptoms are under control, and I am able to turn my attention back to my family, friends and work, instead of on my RLS." Requip(R) Proven Effective in Treating Moderate-to-Severe Primary RLS The approval of Requip for moderate-to-severe primary Restless Legs Syndrome is supported by data from four double-blind, randomized, placebo- controlled clinical trials in adults diagnosed with RLS. Patients with RLS secondary to other conditions (e.g. iron deficiency, pregnancy and renal failure) were excluded from the study groups. "One of the principal benefits of treatment with Requip is relief of the urge to move the legs," said Dr. William Ondo, Associate Professor of Neurology at Baylor College of Medicine, Houston, Texas. "Requip targets what doctors believe may be an underlying cause of the disorder, which is dysfunction of a system involving the brain chemical dopamine. Now there is an approved treatment specifically for moderate-to-severe primary RLS which should help to validate this under-recognized and misunderstood condition." In the most recently completed U.S. trial, Requip significantly improved symptoms of moderate-to-severe primary RLS in patients from baseline to week 12, according to two validated measurement tools: the International RLS Rating Scale (IRLS Scale) and Clinical Global Impression-Global Improvement (CGI-I) scale. Patients taking Requip achieved a significantly greater mean improvement in IRLS Rating Scale total score compared to the placebo group (-13.5 points versus -9.8 points, respectively; p<0.0001) and significantly more patients taking Requip showed a "much improved" or "very much improved" score on the CGI-I scale compared with the placebo group (73.3 percent versus 56.5 percent, respectively; p=0.0006). In two other similarly designed trials that took place in centres largely outside of the U.S., Requip also significantly improved IRLS Rating Scale and CGI-I scale scores from baseline to week 12. Long-term maintenance of efficacy in the treatment of RLS was demonstrated in a 36-week relapse prevention study. In this trial, patients taking Requip demonstrated a significantly lower relapse rate compared with patients randomized to placebo (32.6 percent vs. 57.8 percent, p=0.0156). In clinical trials in the treatment of moderate-to-severe primary RLS, the most commonly observed adverse events for Requip (n=496) versus placebo (n=500) were nausea (40 percent versus 8 percent), somnolence (12 percent versus 6 percent), vomiting (11 percent versus 2 percent), dizziness (11 percent versus 5 percent) and fatigue (8 percent versus 4 percent). Occurrences of nausea in clinical trials were generally mild to moderate in intensity.
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 Restless Legs-Patientforeningen
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