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GSK's Adartrel RLS treatment receives positive decision from EC

LondonTuesday, April 11, 2006, 08:00 Hrs  [IST]

The European Commission has adopted a positive decision on the marketing authorisation application for Adartrel (ropinirole) of GlaxoSmithKline (GSK) 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, according to a company release. "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," Andrew Witty, President of Pharmaceuticals Europe, GSK said adding, "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." 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. 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.

 
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