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INVEGA® Approved as Treatment for Schizophrenia in Adolescents
Date:4/11/2011

ion 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%), akathisia (restlessness) (9%), headache (9%), and insomnia (9%).

Please see the Important Safety Information below. Please visit http://janssen.com/products.html for additional important product information.

IMPORTANT SAFETY INFORMATION FOR INVEGA® (paliperidone)

WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), lar
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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