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FDA approves first paediatric antipsychotic in US

The FDA approves J&J's anti-psychotic Risperdal, the first ever approved for use in US children and adolescents aged 12 years or older with schizophrenia or bipolar disorder

The FDA has approved Johnson & Johnson's anti-psychotic drug Risperdal (risperidone), the first ever drug approved for use in children and adolescents aged 12 years or older with schizophrenia or bipolar disorder.

The agency approved Risperdal back in 1993 for treating schizophrenia in adults. It was then approved for the short-term treatment of acute manic or mixed episodes of bipolar I disorder in adults and the treatment of irritability-associated autism in children and adolescents aged five to 16.

Risperdal has been widely prescribed off-label for children, which has caused some controversy as experts say there is insufficient data to suggest the drug is safe for children. The off-label use prompted investigations by various authorities into Johnson & Johnson's Janssen unit in March 2007.

Dr Charles Goodstein, clinical professor of psychiatry at New York University Medical School, has warned that although the drug had demonstrated efficacy in children, caution should be exercised by doctors regarding the prescribing of powerful medications in young children and adolescents.

Dr Goodstein added that diagnosing children with these conditions was difficult and could lead to mis- or over-diagnosis and the prescribing of inappropriate medications or those with side effects.

The FDA, however, disagreed and cited a short-term, double-blind, controlled trial in schizophrenic teenagers, who had fewer symptoms, including a decrease in hallucinations, delusional thinking and other symptoms. The second study was a three-week, randomised, double-blind, placebo-controlled trial in children with bipolar disorder, who had had fewer symptoms, including a decrease in their elevated mood and hyperactivity.

Dianne Murphy, director of the FDA's Office of Paediatric Therapeutics, said: "The paediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the paediatric population. These data have permitted the identification of the effective paediatric dose ranges and have provided an evidence-based approach for treating these disorders in paediatric patients."

Risperdal racked up sales of USD 4.2bn in FY06, an increase of 17.8 per cent on FY05. The compound patent for the treatment is scheduled to expire in the US in December 2007. The company has submitted paediatric data to the FDA in order to extend exclusivity through to June 2008.

2nd September 2008

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