Mundipharma’s Targin has been granted a licence in the EU for the treatment of restless leg syndrome (RLS).
It is the first opioid to be granted a licence in the EU for RLS, a neurological disorder characterised by an overwhelming urge to move, usually affecting the legs.
The approval covers the of the fixed combination of prolonged-release oxycodone/naloxone as a second line treatment for patients with severe to very severe idiopathic RLS, offered after the failure of dopaminergic therapy.
Dr Karen Reimer, managing director of Mundipharma, commented: “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 options for people with RLS who are not gaining sufficient relief from their symptoms.”
The 12-week double blind, randomised placebo-controlled trial, which has a 40-week open-label extension, found that 42% of patients who took the combination were considered RLS remitters after 12 weeks compared to 19% in the placebo group.
At the end of the 40-week extension, 43% were considered remitters and 22% of those were considered asymptomatic by the International RLS Study Group severity rating scale.
Adverse effects noted in the study, occurring in less than one in ten of patients, included gastrointestinal disorders, headaches, drowsiness, fatigue, itching and excessive sweating.