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news.Mundipharma has received positive decision from the European Commission for a new indication of Targin (Targinact, Targiniq) as a second line symptomatic treatment for patients with severe to very severe idiopathic restless legs syndrome (RLS), after failure of dopaminergic therapy.
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Targin is a fixed combination of prolonged-release oxycodone/naloxone, which is the first opioid which has been granted a licence in the EU to treat RLS.
According to the company, the new licence indication provides a viable treatment option for patients who cannot tolerate the existing available treatments or who are not able to gain the level of symptom relief required.
So far, symptomatic treatment of idiopathic RLS included mainly dopamine agonists or dopaminergic substances such as L-dopa, but long-term use can lead to worsening of the symptoms in many individuals.
Mundipharma Research managing director Dr Karen Reimer said: "RLS can have a devastating impact on a patient’s life.
"The manifestation of physical symptoms at night time can disturb sleep which can lead to profoundly disruptive daytime fatigue, impaired concentration and even feelings of depression.
"This new indication for Targin provides a much needed new treatment option for people with RLS who are not gaining sufficient relief from their symptoms."
Currently, oxycodone/naloxone is licensed to treat RLS in Germany only, in the same second line setting as in the recent EC positive decision, which is legally binding and needs to be implemented into the national marketing authorisations within 30 days.
Data from the double-blind, randomized placebo-controlled trial showed a significant improvement in the Mean International RLS Study Group rating scale (IRLS) in the prolonged release oxycodone/naloxone group vs. placebo at 12 weeks.