Restless Legs Syndrome treatment approved in EU

New combination opioid drug will soon be available to prescribe in the UK

The prolonged-release version of oxycodone/naloxone (Targin) has been cleared for approval by the European Commission this week as a second-line symptomatic treatment for patients with severe to very severe idiopathic restless legs syndrome, after failure of dopaminergic therapy.

Restless Legs syndrome (RLS), also known as Willis-Ekbom disease, is estimated to effect between 5 per cent to 10 per cent of adults in some Western countries.

Oxycodone/naloxone is the first opioid which has been granted a licence in the EU for the treatment of RLS. It also has a licence to treat pain in certain patients.

The typical course of treatment for symptomatic treatment of idiopathic RLS includes dopamine agonists or dopaminergic substances such as L-dopa.

The new drug combination therapy will now need to be accepted by the EU’s Members States within the next 30 days, meaning it should be available in the UK by the Spring.

Data published in the December 2013 issue of The Lancet Neurology was used to support the basis of this new indication approval.

Findings from the 12-week double-blind, randomised placebo-controlled trial with a 40 week open-label extension, showed a significant improvement in the Mean International RLS Study Group rating scale (IRLS) in the prolonged release oxycodone/naloxone group when compared to placebo (-16.5 versus -9.4)

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