Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Mundipharma's Targin as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome (RLS).
Subscribe to our email newsletter
Targin is a fixed combination of opioid agonist oxycodone and opioid antagonist naloxone in prolonged-release oral tablets.
The drug, which is currently licensed for the treatment of RLS in Germany only, is the first opioid which has been granted a positive opinion by the CHMP for the treatment of RLS.
The company said that the positive opinion adopted by the CHMP will now go through the standing committee procedure to be converted into a legally binding decision by the European Commission (EC) and this process would typically take about two months.
However, the national phase of the approval process will have to be completed in relevant markets before the product receives a marketing authorization.
Mundipharma International managing director Antony Mattessisch said: "This CHMP positive opinion provides new hope for patients who cannot tolerate the existing available treatments or who are not able to gain the level of symptom relief required.
"We look forward to continuing to work with the regulatory authorities to bring this new option to patients."
The drug has been approved in 37 countries worldwide, and in the EU it is indicated to treat severe pain which can be adequately managed only with opioid analgesics.