Johnson & Johnson's
Risperdal, an adult antipsychotic drug, was approved by the Food and Drug Administration Friday to treat irritability in autistic children and adolescents.
The approval is the first for the use of a drug to treat behaviors associated with autism in children, the FDA said. The behaviors include aggression, deliberate self-injury and temper tantrums.
"This approval should benefit many autistic children as well as their parents and other care givers," said Dr. Steven Galson, director of teh FDA's Center for Drug Evaluation and Research. "Our agency strongly encourages the development of appropriate pediatric labeling for adult drugs, and Risperdal is a welcome addition to the growing number of such products that have been shown to have an appropriate risk-benefit profile when tested in children."
"Autism is a complex disease," said Dr. James McCracken, director of the Division of Child and Adolescent Psychiatry at the Semel Institute for Neuroscience and Human Behavior at UCLA. "And while no one treatment is appropriate for all patients, in our studies we found that Risperdal is highly effective in managing these severe and challenging behaviors often seen in children with autism."
Risperdal (risperidone) has been approved since 1993 for the short-term treatment of adults with schizophrenia, and since 2003 for the short-term treatment of adults with acute manic or mixed episodes associated with extreme mood swings.
The product's effectiveness in the symptomatic treatment of irritability associated with pediatric autistic disorders was established in two eight-week, placebo-controlled trials in 156 patients ages 5 to 16 years, 90% of whom were 5-12 years old.
Share of J&J closed down 5 cents, to $65.06, on Friday.