EC Approves Janssen’s Extended-Release Injectable Schizophrenia Drug Xeplion

The EC has approved Janssen-Cilag’s Xeplion® (paliperidone palmitate) once-monthly injectable antipsychotic for the treatment of schizophrenia. The formulation is indicated for the maintenance treatment of schizophrenia in adult patients stabilized with paliperidone or risperidone. Patients with mild-to-moderate symptoms who have shown previous responsiveness to oral paliperidone or risperidone may be treated using Xeplion without having undergone prior stabilization.

Xeplion will be available in Europe in five different dosages. Once-monthly injectable paliperidone is already available in the U.S., trademarked Invega® Sustenna™.

Janssen says EC clearance of Xeplion in the EU was based on data from four placebo-controlled trials. These included studies evaluating the drug for acute symptom control, and longer-term maintenance symptom control and relapse delay.