Johnson & Johnson subsidiary Janssen-Cilag International has been granted approval by the European Commission (EC) for the use of Trevicta (paliperidone palmitate three-monthly injection) for the maintenance treatment of schizophrenia in adult patients.
Available in the European Union (EU) as the longest dosing interval for an antipsychotic medication, Trevicta enables adult schizophrenia patients to maintain an optimal level of treatment in their blood with fewer administrations of the drug, compared to existing antipsychotic treatments.
Trevicta can be used for the maintenance treatment of schizophrenia in adult patients who are clinically stable on Xeplion.
Xeplion is a one-monthly paliperidone palmitate product that was approved in 2011 for the maintenance treatment of schizophrenia in the EU.
Janssen-Cilag Neuroscience and Pain European therapeutic area leader Dr Andreas Schreiner 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 marketing authorisation for Trevicta has been granted based on two Phase III studies, the first being a randomised, multi-centre, double-blind, placebo-controlled, relapse prevention study in schizophrenia patients.
The second randomised, multi-centre, double-blind study compared the efficacy and safety of paliperidone palmitate three-monthly and one-monthly formulations.
The medication comes with a few commonly observed drug reactions such as anxiety, headache, insomnia, increased weight, upper respiratory tract infection and injection site reaction.
With the approval, Janssen-Cilag will be able to market Trevicta across all 28 EU states, as well as the European Economic Area countries including Iceland, Norway and Liechtenstein.