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Adartrel (Ropinirole) Becomes First RLS Treatment to Receive Positive Decision From the European Commission LONDON, UK -- April 7, 2006 -- GlaxoSmithKline announced today that the European Commission has adopted a positive decision on the marketing authorisation application for Adartrel® (ropinirole) for the treatment of moderate to severe idiopathic RLS (restless legs syndrome). GSK now expects national marketing authorisations for Adartrel to be issued in all member states of the European Union from May 2006 onwards. RLS is a neurological movement disorder characterised by an uncontrollable urge to move the legs and painful or distressing sensations in these limbs. These sensations are sometimes described by patients as creeping, crawling, burning or pulling. The symptoms are worse in the evening and at night, become worse with rest, and improve with movement. "RLS can have a significant negative impact on quality of life for patients due to the chronic inability to fall or stay asleep, which can lead to daytime exhaustion, difficulty concentrating and reduced interest in normal activities," said Andrew Witty, President of Pharmaceuticals Europe, GSK. "Data show that Adartrel is effective in improving RLS symptoms thereby reducing sleep disturbance and improving quality of life. This decision will provide patients and their doctors with a new option to treat this common, debilitating condition.1" Clinical trials have assessed the benefit of ropinirole in improving RLS symptoms. Pooled data for moderate to severe RLS patients across trials indicate:1,2 · Ropinirole significantly improved sleep parameters (as measured by the Medical Outcomes Study Sleep scale) - sleep disturbance, sleep quantity, sleep adequacy and daytime somnolence at week 12 compared to placebo (P <.0001). · Ropinirole significantly improved RLS symptoms (as measured by the International Restless Leg scale) compared to placebo (treatment difference for mean change from baseline at week 12 -4.0, P <.0001). · Ropinirole was also shown to significantly reduce periodic limb movements of sleep (PLMS).1,7 In clinical trials, the most commonly observed adverse events for Adartrel versus placebo were nausea (38% versus 8%), somnolence (12% versus 7%), vomiting (13% versus 2%) and dizziness (12% versus 5%).1 Occurrences of nausea were transient and generally mild to moderate in intensity. Fainting or low blood pressure may occur during initial treatment or with increases in dose. Safety and efficacy have not been demonstrated in paediatric patients with RLS.1 Adartrel is a dopamine agonist that acts by 'mimicking' dopamine in the brain, thereby increasing the activity of neurotransmission. While the primary cause of RLS is unclear, there is evidence that it may be related to abnormalities in the central dopamine system in the brain. Dopamine is a monoamine neurotransmitter essential to the normal functioning of the central nervous system. Adartrel was developed by GlaxoSmithKline, one of the world's leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Background on RLS RLS sensations occur during rest, often in the evening or at night. These sensations are exacerbated by rest while movement can provide temporary relief. An important cause of insomnia, RLS affects an estimated 5-10% of the general adult population.3,4 Three percent of the population experiences moderately to severely distressing RLS symptoms (at least 2 to 3 times per week) and may benefit from treatment.4 Individuals with RLS often experience severe sleep impairment resulting in daytime fatigue. Approximately 80% of people with RLS have involuntary repetitive movements called periodic limb movements during sleep that typically occur every 20 to 30 seconds on and off throughout the night contributing to sleep disturbance.3 Findings from the RLS Epidemiology, Symptoms and Treatment (REST) study, the largest and most comprehensive study of the prevalence, burden and diagnosis of RLS across Europe and the U.S., show that most patients who seek medical advice for RLS symptoms are misdiagnosed and continue to suffer from the distressing condition. In the survey of patients with RLS symptoms, 65% reported consulting a physician about their symptoms during the past 12 months; of those, 58 per cent reported receiving a diagnosis, but only 12.9% reported being diagnosed with RLS. Those who were misdiagnosed had their symptoms wrongly attributed to such conditions as varicose veins or lower back problems.4 Researchers have concluded that RLS often runs in families which would imply a genetic element. However this is not always the case and the condition can occur sporadically. Physicians diagnose RLS based on a discussion with the patient about their symptoms. Currently, no laboratory tests can confirm the diagnosis of RLS. REFERENCES: 1. Data on file (pooled data from studies 190, 191, 194 and 249 for moderate to severe patients with baseline IRLS score > 24), GlaxoSmithKline. 2. Adartrel (ropinirole) Product Characteristics. 3. Allen R, Becker PM, Bogan R, Schmidt M, Kushida CA, Fry JM, Poceta S, Winslow D. Ropinirole Decreases Periodic Leg Movements and Improves Sleep Parameters in Patients with Restless Legs Syndrome. Sleep 2004; 27(5): 907–914. 4. Roehrs T, Zorick F Sicksteel J et al. Age-related sleep-wake disorders at a sleep disorder centre. J Am Geriatr Soc 1983; 31:36, 4-70. 5. Hening W, Walters AS, Allen RP et al. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med 2004; 5: 237-246. 6. Trenkwalder C, Garcia-Borreguero D, Montagna P, Lainey E, de Weerd A W, Tidswell P, Saletu-Zyhlarz G, Telstad W, Ferini-Strambi L, on behalf of the TREAT RLS 1 Study Group. Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries. J Neurol Neurosurg Psychiatry 2004; 75: 92–97. 7. Walters AS, Ondo WG, Dreykluft T, Grunstein R, Lee D, Sethi K. Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: A 12-week, double-blind, randomized, parallel-group, placebo-controlled study. Mov Disord. 2004 Dec;19(12):1414-23. 8. Haan J, Volc D, Montplaisir J. The long-term management of RLS with ropinirole: maintained efficacy over 36 weeks. International Congress of Parkinson's Disease and Movement Disorders, Rome, Italy, Jun 13–17 2004. Mov Disord 2004; 19(suppl 9): S420: P1232. SOURCE: GlaxoSmithKline E-mail this page to a friend or colleague! To print, use this version