The European Commission (EC) has approved the use of paliperidone palmitate (TREVICTA) – a 3-monthly injection – for the maintenance treatment of schizophrenia in adult patients.
The approval of paliperidone palmitate means patients will now be able to maintain an optimal level of treatment in their blood with fewer administrations compared to currently available antipsychotic treatments.
It is hoped such a development will improve outcomes for patients, carers and healthcare professionals. Paliperidone palmitate is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on XEPLION, a 1-monthly paliperidone palmitate product that was approved in 2011 for the maintenance treatment of schizophrenia in the European Union (EU).
The marketing authorisation for TREVICTA 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 was a randomised, multi-centre, double blind study comparing the efficacy and safety of paliperidone palmitate 3-monthly and 1-monthly formulations. TREVICTA 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.
Dr Andreas Schreiner, European therapeutic area leader, neuroscience and pain at pharmaceutical company Janssen, said: “This approval is a big step forward for people living with schizophrenia.
“With fewer administrations per year compared to other approved treatments, TREVICTA can give people with schizophrenia greater freedom to focus on other important aspects of their life and less on their treatment. This new option has the potential to reduce the likelihood of relapse and progression of the disease. It also helps healthcare professionals ensure the person with schizophrenia can benefit from continuous delivery of medication between administrations.”
The most frequently-observed side effects, reported in less than 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.
The decision from the EC follows a Positive Opinion recommending the approval of TREVICTA from the Committee for Medicinal Products for Human Use of the European Medicines Agency in April.
This approval allows for the marketing of TREVICTA in all 28 member states of the EU as well as the European Economic Area countries (Norway, Iceland and Liechtenstein).