Risperdal approved for Autism Symptoms in children and teens

Johnson & Johnson won U.S. approval to market its best-selling schizophrenia drug Risperdal for autism symptoms in children and teens.
The medication can be prescribed for children ages 5 to 16 to relieve signs of autism including aggression, temper tantrums, deliberate self-injury and rapid mood swings, the Food and Drug Administration said today in an e-mailed statement.
Risperdal, which had worldwide sales of $3.55 billion last year, is the first medication approved in the U.S. to treat autism symptoms, New Brunswick, New Jersey-based J&J said. It cannot cure autism. The market for antipsychotic treatments also includes Eli Lilly & Co.'s Zyprexa, AstraZeneca Plc's Seroquel, Pfizer Inc.'s Geodon and Bristol-Myers Squibb Co.'s Abilify.
``Having FDA approval means more physicians will have clear instructions on the label for how to use Risperdal for autism symptoms,'' said Peter Bell, president and chief executive officer of Cure Autism Now. ``It also means some patients who haven't been able to get insurance to pay for the treatment will now have an easier time getting the drug covered for autism.''
Doctors have been using Risperdal ``off label'' to treat autism symptoms in children for more than a decade, said Bell, whose Los Angeles-based advocacy group funds autism research.
Health insurers often limit prescription-drug coverage to uses of medications specified in FDA's approvals, which define how companies can market a treatment. Before, Risperdal was only approved for use as an antipsychotic and patients with autism didn't get coverage, Bell said.
Previous Approvals
``Insurance companies had argued that efficacy was not proven,'' Bell said. ``Now that Risperdal is approved for autism, they can't keep doing that.''
Shares of J&J fell 5 cents to close at $65.06 in New York Stock Exchange composite trading. They've risen 5.7 percent in the past 12 months.
Risperdal has been approved since 1993 for the short-term treatment of adults with schizophrenia, and since 2003 as a short-term therapy for adults with acute manic or mixed episodes associated with extreme mood swings. Once the FDA grants approval to a medicine for one use, doctors can prescribe it for other, so-called off-label indications.
The most common side effects of the use of Risperdal include drowsiness, constipation, fatigue and weight gain, the FDA said.
The antipsychotic medication can also reduce mood swings in autistic children, as well as tendencies toward self-injury and temper explosions, said James McCracken, professor of child psychiatry at the Geffen School of Medicine at the University of California, Los Angeles, in a telephone interview today.
Prospective Remedies
``There is active interest in exploring other antipsychotics for this use,'' said McCracken. ``There have been some studies on Zyprexa and I have seen some reports of research starting on Abilify.''
About 1.5 million Americans have autism, a developmental disability that often appears in the first three years of life, according to the U.S. Centers for Disease Control and Prevention in Atlanta. Children and teens with autism typically have difficulty with communication and social interaction.
Between three and six of every 1,000 children have the condition, and boys are four times more likely to be diagnosed with it, according to the U.S. National Institute of Neurological Disorders and Stroke.
Most therapies and interventions for autism are designed to address specific problems, such as improving speaking and other communication skills or breaking obsessive and repetitive routines.
Research Results
Risperdal eased aggression by more than 50 percent in a study published in the Aug. 1, 2002, edition of the New England Journal of Medicine. No drugs are approved in the U.S. for calming children with autism, and their behavior can make it difficult for them to benefit from educational and therapeutic programs, the researchers said.
The drug helped children who tried daily to harm themselves, as well as those with symptoms such as severe tantrums, agitation, unstable moods and aggression. The drug didn't treat the autism itself.
Doctors often prescribe an antidepressant medication to handle symptoms of anxiety, depression, or obsessive-compulsive disorder, according to the National Institute of Mental Health. Anti-psychotic medications are used to treat severe behavioral problems.
Other Treatments
Seizures can be treated with one or more anticonvulsant medications. Stimulant drugs, such as those used for children with attention deficit disorder, or ADD, are sometimes used effectively to help decrease impulsivity and hyperactivity.
``This approval should benefit many autistic children as well as their parents and other care givers,'' said Steven Galson, M.D., director of the 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.''