GSK FILES EUROPEAN SUBMISSION FOR TREATMENT OF RESTLESS LEGS SYNDROME
Ropinirole (Requip) Shown to Help Patients with Distressing Neurological Condition
HELSINKI, Finland, 31 August 2003. GlaxoSmithKline (GSK) announced today it has submitted an application in Europe for an indication for ropinirole/requip, its dopamine agonist, in the management of RLS (restless legs syndrome). This submission is supported by the largest programme of research in RLS conducted to date.
Approximately three percent of the general population has RLS, also known as Ekbom’s syndrome, such that medical intervention may be warranted. The syndrome has both sensory and motor components, which can combine to have a profound impact on sleep.
RLS is characterised by an uncontrollable urge to move the legs, and painful or distressing sensations in the lower limbs that are sometimes described as creeping, crawling, burning or pulling. These sensations occur during rest and are relieved through movement. Symptoms often appear during the evening or at night, and as a result, RLS can lead to significant sleep disturbances, which can impact both the sufferer and their partners. Recent research has shown that the burden of RLS symptoms on health-related quality of life is considerable and comparable with that of other chronic medical conditions, such as Type 2 diabetes, hypertension and depression. 1.)
Dr Pierre Pellier, Vice President of Clinical Development and Medical Affairs for GlaxoSmithKline, comments, "Up to now, most of the medications have been targeted at the symptoms of sleeplessness. By contrast, ropinirole/requip effectively treats RLS by targeting an underlying dompaminergic defect that contributes to RLS development.”
The application for approval of ropinirole/requip in the management of RLS is supported by four double-blind studies; three of these studies were carried out for a 12-week treatment period, and one almost nine months treatment. 2.) 3.) 4.)
Results of the double-blind studies have shown that ropinirole/requip at doses of up to 4.0 mg were superior to placebo, and effectively treated both the sensory and motor symptoms of RLS.
The most commonly reported adverse events in the studies were headache and nausea.
(Ansøgningen er indsendt i Finland. Ifølge GlaxoSmithKline Danmark er proceduren den, at indikationen først godkendes i Finland og derefter i de andre EU lande (gensidig anerkendelsesprocedure). GlaxoSmithKline forventer Requip godkendt til behandling af Restless Legs i Danmark i begyndelsen af 2005).
1. Kirsch J, Abetz L, Allen R, Follet A, Washburn T. The impact of restless legs syndrome on quality of life. October 2002, European Federation of Neurological Societies, Austria.
2. Ferini-Strambi L, Garcia-Borreguero D, Lainey E, Trenkwalder C. Ropinirole in the treatment of restless legs syndrome (RLS): A randomised, double-blind, placebo-controlled, multinational study. Abstract for EFNS 2003
3. Dreykluft T, Walters A, Ondo W, Sethi K, Grunstein R, Hyman N. Ropinirole versus placebo in restless legs syndrome: Efficacy, safety and qulity of life results from a 12-week double-blind international study. Abstract for EFNS 2003
4. Allen R, Becker P, Bogan R, Fry J, Poceta J. Restless Legs Syndrome (RLS): The efficacy of ropinirole for the treatment of periodic leg movements of sleep (PLMS). Abstract for EFNS 2003
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About GlaxoSmithKline
GlaxoSmithKline is one of the worlds leading research-based pharmaceutical companies. The companys mission is to help people live longer and feel better.
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About European Federation of Neurological Societies (EFNS)
EFNS in Vienna, Austria is an organisation that unites and supports neurologists across the whole of Europe.
Currently 40 European national neurological societies are registered members of the EFNS, which represents more than 12,000 European neurologists.
The role of the EFNS is:
• To advance the development of neurology as an independent speciality caring for all patients with a disease of the nervous system
• To support that these services become available to all Europeans
• To support research and dissemination of research results throughout Europe
• To organise and support neurological teaching at the pregraduate as well as the postgraduate level throughout Europe
• To handle the current political issues in European neurology on behalf of its members
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