EC approves Trevicta for the treatment of schizophrenia

The European Commission (EC) has approved the use of Janssen’s Trevicta (paliperidone palmitate a 3-monthly injection) for the maintenance treatment of schizophrenia in adult patients.

Trevicta will provide the longest dosing interval available for an antipsychotic medication in the EU, allowing patients to maintain an optimal level of treatment in their blood with fewer administrations, compared to currently available antipsychotic treatments. This may improve outcomes for patients, carers and healthcare professionals. Trevicta 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.

Commenting on the approval, Dr Andreas Schreiner, European Therapeutic Area Leader, Neuroscience and Pain, Janssen, said: “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.”

Approval based on two Phase III studies

The marketing authorisation for Trevicta 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 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.

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.