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Risperdal approved in teens for schizophrenia and BPD.

The Food and Drug Administration has approved risperidone for the treatment of schizophrenia in adolescents aged 13-17 years and for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder in children and adolescents aged 10-17 years, after years of off-label use by many physicians.

"This is the first FDA approval of what are known as atypical antipsychotic drugs to treat either of these disorders in the pediatric population," Dr. Thomas Laughren, director of the division of psychiatry products in FDA's Center for Drug Evaluation and Research, said during a teleconference announcing the approval.

Until now, there had been no FDA-approved drug for the treatment of schizophrenia for pediatric use, and only lithium is approved for the treatment of bipolar disorder in adolescents more than 12 years of age.

"Both of these disorders are commonly treated off-label in pediatric patients with Risperdal and with other drugs that are approved for treating these conditions in adults," Dr. Laughren said. Risperidone, marketed as Risperdal, is manufactured by Janssen L.P.

The three trials--two for schizophrenia and one for bipolar disorder--looked at two different dose ranges: a low-dose range of roughly 1-3 mg and a higher-dose range of roughly 3-6 mg. "One important finding from both of these programs--in schizophrenia and bipolar disorder--[is that] there didn't appear to be any additional efficacy for the higher dose compared to the lower dose. We think that's important information to provide to prescribers," Dr. Laughren said. Higher doses were associated with more side effects.

The efficacy of risperidone in the treatment of schizophrenia in adolescents was demonstrated in two short-term (6 to 8 weeks), double-blind, controlled trials, involving more than 430 adolescents. All patients were experiencing an acute episode of schizophrenia at the time of enrollment. Treated patients generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness.

The efficacy of risperidone in the treatment of manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a 3-week, randomized, double-blind, placebo-controlled trial involving 160 patients who were experiencing a manic or mixed episode. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity and in other symptoms of their illness.

The studies supporting approval were requested by the FDA through a pediatric written request, which is part of the agency's pediatric drug development initiatives.

Common side effects included drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash. That adverse event profile is quite similar to what has been seen in adults, Dr. Laughren said.

Weight gain and diabetes have been a concern in adult patients on risperidone, but the risk in children and adolescents is not yet clear.

"There are some data coming out of these gain trials ... suggesting that there is a signal for some weight gain with this drug and that's characterized in labeling," Dr. Laughren said. "We didn't really see in these relatively short-term trials any clear signal for lack of regulation of glucose, which is a precursor to diabetes." Longer studies are necessary to assess the risk of weight gain and diabetes with use of the drug in this population.

The drug is already approved for the treatment of schizophrenia and short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and the treatment of irritability associated with autistic disorder in children and adolescents 5-16 years old.


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Title Annotation:Adolescent Health; bipolar disorder
Author:Wachter, Kerri
Publication:Internal Medicine News
Geographic Code:1USA
Date:Sep 15, 2007
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