A new drug has been approved for a rare population — teens with schizophrenia. The illness is typically diagnosed first in young adulthood, usually the early 20s. But the U.S. Food and Drug Administration (FDA) decided that teens ages 12 to 17 years of age need another treatment option.
On April 6, the FDA approved Invega (paliperidone) extended-release tablets for the treatment of schizophrenia in this age group. The efficacy of Invega to treat schizophrenia in adolescents was established in a single six-week clinical study.
Invega is an atypical antipsychotic medication and was first approved in December 2006 for the treatment of schizophrenia in adults.
Schizophrenia is a complex, chronic mental disorder that causes a variety of symptoms which can include hearing voices, having fixed false beliefs or delusions, disorganized thinking and unusual behaviors.
“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., of Johnson & Johnson Pharmaceutical Research & Development. “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 lifelong 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 single, 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 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). Like most atypical antipsychotic medications, significant weight gain is often a side effect as well.
Invega is marketed by Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Source: FDA and Janssen