Janssen-Cilag International NV announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a Positive Opinion recommending marketing authorisation in the European Union for the medicinal product TREVICTA® (paliperidone palmitate a 3 monthly injection) for the maintenance treatment of schizophrenia. If approved, this 3 monthly injection will allow patients to maintain an optimal level of treatment in their blood with fewer administrations, compared to currently available antipsychotic treatments, and therefore may improve outcomes for patients, carers and HCPs.1 A 1 monthly formulation of paliperidone palmitate (XEPLION®) is approved for the maintenance treatment of schizophrenia in Europe.
The European filing of an Extension Marketing Authorisation Application for paliperidone palmitate, a 3-monthly injection, is based on two Phase 3 studies. The first was a randomised, multi-centre, double-blind, placebo-controlled relapse prevention study in more than 500 patients with schizophrenia. The second study was a randomised, double blind clinical trial comparing the efficacy and safety of paliperidone palmitate 3 monthly and 1-monthly formulations.2 Paliperidone palmitate 3-monthly injection was found to be at least as effective in preventing relapse as the paliperidone palmitate 1 monthly formulation and was not associated with any new or unexpected safety signals.
As with all medications, some patients may experience side effects. The most frequently observed adverse drug reactions reported in ≥ 5% of patients in the two double-blind controlled clinical trials of paliperidone palmitate 3-monthly injection were: increased weight, upper respiratory tract infection, anxiety, headache, insomnia and injection site reaction.
Based on the CHMP's Positive Opinion, a final authorisation from the European Commission is expected in the coming months. Paliperidone palmitate 3-monthly injection is marketed as INVEGA TRINZA® in the U.S. and received approval from the Food and Drug Administration (FDA) under Priority Review in May 2015.
