ANTIPSYCHOTIC APPROVED TO TREAT AUTISM-RELATED IRRITABILITY

The FDA has approved a new indication for one of the leading prescription antipsychotic medications, Risperdal (risperidone), for the treatment of irritability associated with autistic disorder, including symptoms of aggression toward others, deliberate self-injuriousness, temper tantrums and quickly changing moods, in children and adolescents ages 5 to 16, Janssen has announced. This is the first time the FDA has approved any medication for use in children and adolescents with autism, according to the company.

Clinical studies have found that patients with irritability associated with autistic disorder who received Risperdal experienced significant behavioral symptom improvement versus those who were given placebo.

The efficacy of Risperdal in the treatment of irritability associated with autistic disorder was established in two eight-week, placebo-controlled trials in 156 children between the ages of 5 and 16 who met the DSM-IV criteria for autistic disorder. Efficacy was evaluated using two assessment scales: the Aberrant Behavior Checklist (ABC) and the Clinical Global Impression Change (CGI-C) scale. The primary outcome measure in both trials was the change from baseline to endpoint in the irritability subscale of the ABC (ABC-I). The ABC-I subscale measured the emotional and behavioral symptoms of autism. The CGI-C rating at endpoint was a co-primary outcome measure in one of the studies.

Risperdal is also approved in the U.S. to treat acute manic or mixed episodes of bipolar I disorder and for the treatment of schizophrenia in adults.