Titusville, N.J. — The U.S. Food and Drug Administration (FDA) has approved Invega (paliperidone) extended-release tablets for the treatment of schizophrenia in adolescents 12 to 17 years of age. The efficacy of Invega to treat schizophrenia in adolescents was established in one six-week clinical study.
Invega is an atypical antipsychotic medication and was first approved in the U.S. in December 2006 for the treatment of schizophrenia in adults. Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., markets Invega in the U.S.
Schizophrenia is a complex, chronic brain disorder that causes a variety of symptoms which can include hearing voices, having fixed false beliefs or delusions, disorganized thinking, and unusual behaviors. It can begin in late adolescence or early adulthood, and about one percent of adults in the general population has schizophrenia. The prevalence of schizophrenia in adolescents is not known, but it is estimated to be less than in the adult population.
"Although rare, schizophrenia in adolescents is a very serious and disabling brain condition that affects every aspect of an adolescent’s life and has significant consequences,” said Husseini Manji, M.D., F.R.C.P.C., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Pharmaceutical Research & Development, LLC. "This new indication for Invega provides an additional option for clinicians who treat adolescents with schizophrenia and further demonstrates our commitment to helping people with diseases of the brain"
Early diagnosis of schizophrenia and medical treatment are important in managing this life-long disease. Schizophrenia can be successfully treated over time but, like many treatable chronic diseases, there is no known cure. Adolescents with schizophrenia are usually treated with a comprehensive plan, including medication, individual therapy and specialized programs. Medication requires careful monitoring by a skilled clinician.
The efficacy of Invega in adolescents with schizophrenia was established in a six–week randomized, double-blind, placebo-controlled study using a fixed-dose weight-based treatment group design over a dose range of 1.5 to 12 milligrams per day. The study was conducted in several countries, including the United States, and involved adolescents ranging in age from 12 years to 17 years, all of whom met DSM-IV criteria for schizophrenia, with diagnosis confirmation using a specialized diagnostic assessment for affective disorders and schizophrenia.
Efficacy was evaluated using the Positive and Negative Syndrome Scale (PANSS), a validated multi-item inventory composed of 30 individual items to evaluate positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression.
Overall, this study demonstrated efficacy of Invega in adolescents with the dose range of 3 to 12 milligrams a day. The study used a weight-based dosing regimen with a low, medium, and high dose groups. Invega was adequately tolerated within the dose range of 3 to 12 milligrams a day. Adverse events were dose related. In the total paliperidone treatment group the most commonly reported adverse events in this study were: somnolence (sleepiness) (13 percent), akathisia (restlessness) (9 percent), headache (9 percent), and insomnia (9 percent).
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