Janssen receives CHMP Positive Opinion for Trevicta recommending approval in EU for maintenance treatment of schizophrenia

If approved, Trevica will be the first treatment for schizophrenia to be administered four times a year and will provide the longest dosing interval available for an antipsychotic medication in the EU.

“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. The second study was a randomised, double-blind clinical trial comparing the efficacy and safety of paliperidone palmitate 3-monthly and 1-monthly formulations. 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.

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 US and received approval from FDA under Priority Review in May 2015.