Janssen announces CHMP positive opinion for use of paliperidone palmitate 3-monthly injection for schizophrenia treatment

Apr 4 2016

If approved, paliperidone palmitate 3-monthly injection will be the first once-every-three-months treatment for schizophrenia in the UK

Janssen UK announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the use of paliperidone palmitate 3-monthly injection for the maintenance treatment of schizophrenia in the European Union. This means the paliperidone palmitate 3-monthly injection is on track to become the first once-every-three-months treatment for schizophrenia in the UK, providing the longest dosing interval available for an atypical antipsychotic medication.

A once-monthly formulation of paliperidone palmitate (XEPLION^®) has previously been approved for the treatment of schizophrenia in Europe. The reduced administration required for paliperidone palmitate 3-monthly injection could improve outcomes and give freedom to patients and caregivers who are struggling with daily or monthly treatments, and may therefore be at increased risk of relapse.

"The positive opinion for paliperidone palmitate 3-monthly injection is significant news for people with a diagnosis of schizophrenia in the UK because, if approved, it would enable them to focus on getting back to normal life with a much lower burden of medication. Poor adherence to treatment is a major trigger for relapse in schizophrenia, therefore the extended duration of treatment possible with the paliperidone palmitate 3-monthly injection may provide helpful support to patients and reduce the need for intervention by their healthcare professional," said Leonie Stein, Head of Medical Affairs, Janssen UK. "We look forward to the European Commission’s final decision and hope it brings us the opportunity to provide a new treatment option for people with schizophrenia in the UK."

The European filing of an Extension Marketing Authorisation Application for paliperidone palmitate 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 once-monthly formulations. Paliperidone palmitate 3-monthly injection was found to be at least as effective in preventing relapse as paliperidone palmitate once-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 decision from the European Commission is expected later in 2016. 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.