GlaxoSmithKline RLS drug gets EC backing

GlaxoSmithKline (GSK) has announced that the European Commission has come to a positive decision regarding the European marketing application for the Restless Legs Syndrome (RLS) treatment Adartrel.

GSK has said that it now expects that authorisations from all EU member states will begin to be issued from May 2006 onwards.

“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 shows 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, a dopamine agonist, works by mimicking dopamine in the brain, according to GSK, which increases the activity of neurotransmission. It is abnormalities concerned with dopamine in the brain that some believe is the cause of RLS.

In trials, ropinirole, the active ingredient of Adartel, was found to significantly improve symptoms of RLS, improve sleep parameters and reduce periodic limb movements of sleep.

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