Paliperidone Approved for Schizophrenia in Adolescents

Emma Hitt, PhD

April 12, 2011

April 12, 2011 — The US Food and Drug Administration (FDA) has approved paliperidone (Invega; Ortho-McNeil-Janssen Pharmaceuticals) for the treatment of schizophrenia in adolescent patients aged 12 to 17 years. Paliperidone is an atypical antipsychotic and was originally approved in 2006 for the treatment of schizophrenia in adults.

The approval was based on the findings of a 6-week, randomized, placebo-controlled trial that demonstrated the efficacy of monotherapy with extended-release paliperidone in adolescent patients.

The study included patients aged 12 to 17 years from several countries, including the United States. All patients had schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria and were reassessed with diagnostic tools specifically developed for affective disorders and schizophrenia.

Patients assigned to low-, medium-, and high-dose groups received a fixed-dose, weight-based treatment of 1.5 to 12 mg/day of paliperidone and were evaluated using the Positive and Negative Syndrome Scale.

Across the study, paliperidone was effective over a dose range of 3 to 12 mg/day.

Patients tolerated the drug satisfactorily within the effective dose range, and adverse events were dose related. Adverse events in the paliperidone treatment group included somnolence (13%), akathisia (9%), headache (9%), and insomnia (9%).

"This new indication...provides an additional option for clinicians who treat adolescents with schizophrenia and further demonstrates our commitment to helping people with diseases of the brain," Husseini Manji, MD, with Johnson & Johnson Pharmaceutical Research & Development LLC, said in a written release.

Paliperidone is a centrally active dopamine D(2)- and serotonergic 5-HT(2A)-receptor antagonist. The extended-release formulation allows once-a-day dosing. The controlled release rate provides gradual ascending plasma concentrations peaking at 24 hours after the first dose and minimal fluctuation thereafter. Steady-state levels are obtained after 4 daily doses.