The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Targin. By Mundipharma, Targin is a fixed combination of prolonged-release oxycodone/naloxone, and is a second-line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome (RLS), after failure of dopaminergic therapy.
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, a process that typically takes about 2 months. Subsequent to the European Commission decision, the national phase of the approval process will need to be completed in relevant markets before the product receives a marketing authorization.
“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,” says Antony Mattessisch, managing director, Mundipharma International.
Targin is the first opioid that has been granted a positive opinion by the CHMP for the treatment of RLS. Targin is currently licensed for the treatment of RLS in Germany only, in the same second line setting as approved today by the CHMP.
