JANSSEN'S INVEGA APPROVED TO TREAT SCHIZOPHRENIA

The FDA has approved Invega (paliperidone) Extended-Release Tablets, a new atypical antipsychotic, for the treatment of schizophrenia. The once-daily oral medication is specifically designed to deliver paliperidone -- the active ingredient derived from risperidone -- through the innovative OROS extended-release technology, demonstrating powerful efficacy and a proven safety and tolerability profile. Invega will be marketed by Janssen starting in January.

Invega is the first new prescription treatment for schizophrenia to be approved by the FDA since 2003, according to Janssen.

The effectiveness of Invega in the acute treatment of schizophrenia was established in three six-week, placebo-controlled trials conducted in North America, Europe and Asia, according to the FDA. The 1,665 participating adults were evaluated for the full array of signs and symptoms of schizophrenia. In the three studies using doses ranging from 3 to 15 mg a day, the effectiveness of Invega at relieving symptoms of schizophrenia was superior to the placebo treatment. The recommended dose range for Invega is 3 to 12 mg a day.

Among the commonly reported adverse events were restlessness, extrapyramidal symptoms (movement disorders), rapid heartbeat and sleepiness.