Trevicta (paliperidone palmitate) once every three month injection filed with EMA for schizophrenia- Janssen

Janssen-Cilag International announced the submission of an Extension Marketing Authorisation Application to the European Medicines Agency (EMA) for Trevicta (paliperidone palmitate) once-every-three-months formulation for the treatment of schizophrenia.

The European filing of paliperidone palmitate once-every-three-months is based on two Phase III studies. The first, which was the basis for the FDA submission, is a randomised, multi-centre, double-blind, placebo-controlled relapse prevention study in more than 500 patients with schizophrenia. The second is a randomised, double-blind non-inferiority clinical trial of paliperidone palmitate once-every-three-months and once-monthly formulations. The results will be presented at a scientific congress later this year.

Comment: Paliperidone palmitate once-every-three-months formulation, which obtained FDA priority review and is currently approved and launched in the U.S. (and marketed as Invega Trinza) for patients previously treated with the once-monthly formulation, contains the same active substance as Xeplion but with an extended dosing interval. If approved, it will be marketed as Trevicta in Europe.