EMA approves Trevicta (paliperidone palmitate a three monthly injection) for the maintenance treatment of schizophrenia.- Janssen Cilag
Janssen-Cilag International NV announced that the European Commission (EC) has approved the use of Trevicta (paliperidone palmitate a three 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 European Union, 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 one-monthly paliperidone palmitate product that was approved in 2011 for the maintenance treatment of schizophrenia in the European Union.
Comment: 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 three monthly and one-monthly formulations. Trevicta was found to be at least as effective in preventing relapse as the paliperidone palmitate one monthly formulation and was not associated with any new or unexpected safety signals.
Comment: Trevicta was FDA approved in May 2015.