The US Food and Drug Administration (FDA) approved a new use of one of the leading prescription antipsychotic medications, Risperdal (risperidone), for the treatment of irritability associated with autistic disorder, including symptoms of aggression, deliberate self-injury, temper tantrums and quickly changing moods, in children and adolescents aged five to 16 years. This is the first time the FDA has approved any medication for use in children and adolescents with autism.

"Autism is a complex disease," said James McCracken, M.D., director of the Division of Child and Adolescent Psychiatry at the Semel Institute for Neuroscience and Human Behaviour at UCLA, a primary investigator and consultant to Janssen, L.P. "And while no one treatment is appropriate for all patients, in our studies we found that Risperdal was highly effective in managing these severe and challenging behaviours often seen in children with autism."

Autism is usually diagnosed by age three and may affect one in 250 children. The core symptoms of autism include communication deficits, impaired social interactions and stereotypic behaviours or interests. While Risperdal does not treat these core symptoms, it has been shown to be beneficial in treating the associated behavioural disturbances that can interfere with school and learning, and family life.

Risperdal is also approved in the US to treat acute manic or mixed episodes of bipolar I disorder and for the treatment of schizophrenia in adults. It is marketed by Janssen, L.P.

Risperdal (risperidone) is indicated for the treatment of irritability associated with autistic disorder in children and adolescents (ages five-16 years), including symptoms of aggression towards others, deliberate self-injury, tantrums and quickly changing moods. It is also indicated for the treatment of schizophrenia and for the treatment of manic symptoms of acute manic or mixed episodes associated with bipolar I disorder.

Approved for marketing in more than 100 countries, Risperdal is the most widely prescribed atypical antipsychotic in the world. Janssen, L.P., has marketed Risperdal in the United States since 1994. It is given as an oral tablet, a quick-dissolve tablet or an oral solution.

Based in Titusville, NJ, Janssen, L.P., currently markets prescription medications for the treatment of schizophrenia, bipolar disorder and irritability associated with autistic disorder.