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.
“As paliperidone palmitate 3-monthly injection offers the opportunity for fewer (only four) injections per year, it has the potential to offer eligible patients greater freedom and the opportunity to focus less on taking their medication and more on getting and staying well.” said Dr Andreas Schreiner, European Therapeutic Area Leader, Neuroscience and Pain, Janssen. “The extended dosing interval compared with current treatments may also reduce the risk of relapse for a patient population in whom adherence to antipsychotic medication can be a major factor in the success of their treatment. We anticipate the EMA’s final decision in the coming months and hope that it will allow Janssen to provide patients with a valuable new treatment option for schizophrenia.”
The European filing of an Extension Marketing Authorisation Application for paliperidone palmitate, a 3-monthly injection, is based on two Phase III studies. The first was a randomised, multi-centre, double-blind, placebo-controlled relapse prevention study in more than 500 patients with schizophrenia.1 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.2
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.1,2
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 US and received approval from the Food and Drug Administration (FDA) under Priority Review in May 2015.
- Berwaerts J et al. Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. JAMA Psych 2015;72(8):830–9.
- Savitz A et al. Efficacy and safety of paliperidone palmitate 3-month formulation for patients with schizophrenia: A randomized, multicenter, double-blind, non-inferiority study. Int J Neuropsychopharmacol 2016. doi: 10.1093 [Epub ahead of print].