dm+d
15024911000001100
New Medicines
Targinact, Targin (EU)Restless legs syndrome, severe - second-line after failure of dopaminergic therapy
Information
Targinact, Targin (EU)
Licence extension / variation
Napp
Not Known
Development and Regulatory status
Launched
Launched
None
April 2015
Apr 15Approved in UK [7].
Jan 15Licensed in Germany [6].
Oct 14The EU positive opinion for Targin is for second-line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome, after failure of dopaminergic therapy. The process of converting the positive opinion into a legally binding decision by the European Commission takes about 2 months. Subsequent to the EC decision, the national phase of the approval process will need to be completed in relevant markets before the product receives a marketing authorisation [5].
Oct 14 Recommended for approval [4].
Apr 14A licence application has been filed in the EU [3].
Apr 14Will be filed via the EU mutual recognition procedure [3].
Category
A fixed-combination prolonged release tablet
Prevalence of RLS in adults in the USA and northern Europe is 2–15%. It increases with age and is more common in women than in men About two-thirds of RLS patients have moderate to severe RLS [2]
Restless legs syndrome, severe - second-line after failure of dopaminergic therapy
Oral
Trial or other data
Jan 14NCT01112644 is a PIII randomised, double-blind, placebo-controlled, multicentre study in 205 subjects with moderate to severe idiopathic RLS with daytime symptoms. The primary outcome is changes in the IRLS score at 12 weeks and at 6 months in the extension study. The study completed 2011 [1].
Jan 14Lancet Neurology 2013: 12 (12); 1141-50. This multicentre European study consisted of a 12-week randomised, double-blind, placebo-controlled trial and 40-week open-label extension phase. Patients had symptoms for ≥6 months and an IRLS Study Group severity rating scale sum score of ≥15. Study drug was oxycodone 5mg, naloxone 2.5mg, twice per day, up-titrated as necessary to a maximum of 40/20mg twice daily. The primary outcome was mean change in severity of symptoms based on the IRLS Study Group severity rating scale sum score (SRSSS) at 12 weeks. 306 subjects were randomly assigned and 276 included in the primary analysis. 197 patients participated in the open-label extension. Mean SRSSS at randomisation was 31.6; mean change after 12 weeks was −16.5 in the oxycodone—naloxone group vs −9•4 in the placebo group (mean difference 8•15, 95% CI 5•46—10•85; p