FDA Approves Risperdal to Treat Irritability Associated with Autism
FDA Approves Risperdal to Treat Irritability Associated with Autism
October 6, 2006 - The U.S. Food and Drug Administration (FDA) today approved Risperdal (risperidone) orally disintegrating tablets, an adult antipsychotic drug, for the symptomatic treatment of 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. These behaviors are included under the general heading of irritability, and 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 Steven Galson, M.D., director of 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."
Risperdal 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 8-week, placebo-controlled trials in 156 patients aged 5 to 16 years, 90 percent of whom were 5-12 years old. The results, which were evaluated using two assessment scales, showed that children on Risperdal achieved significantly improved scores for certain behavioral symptoms of autism compared to children on placebo. The most common side effects of the use of Risperdal included drowsiness, constipation, fatigue and weight gain.
Risperdal is marketed by Janssen, L.P. in Titusville, NJ.
Source: FDA Approves the First Drug to Treat Irritability Associated with Autism, Risperdal
Posted: October 2006
Related articles
- FDA Grants Approval for Use of Risperdal Consta as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder - May 18, 2009
- FDA Issues Complete Response Letter for Risperdal Consta for the Adjunctive Maintenance Treatment of Bipolar Disorder - February 11, 2009
- FDA Approves New Injection Site for Risperdal Consta for Schizophrenia Treatment - October 10, 2008
- Supplemental New Drug Application for Risperdal Consta Submitted to the FDA for the Treatment of Bipolar Disorder - July 24, 2008
- Supplemental New Drug Application for Risperdal Consta Submitted to the FDA for the Treatment of Frequently Relapsing Bipolar Disorder - April 14, 2008
- FDA Approves Risperdal to Treat Adolescents with Schizophrenia andChildren and Adolescents with Bipolar Mania - August 22, 2007
- FDA Issues Approvable Letter for Risperdal to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania - June 21, 2007
- FDA Approves New Dose of Risperdal Consta for SchizophreniaTreatment - April 13, 2007
- Risperdal Consta Approved for Schizophrenia - October 29, 2003
- Risperdal Approved for Schizophrenia, Bipolar Mania - December 29, 1993
Risperdal (risperidone) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.