FDA OKs Abilify for Teen Schizophrenia

Nov. 6, 2007 -- The FDA has approved the atypical antipsychotic drug Abilify for the treatment of schizophrenia in teens aged 13-17.

Atypical antipsychotic drugs are a newer type of antipsychotic drugs.

It's only the second drug specifically approved to treat schizophrenia in teens. Last August, the FDA approved Risperdal for the treatment of schizophrenia in adolescents aged 13-17.

Abilify was approved for adults with schizophrenia in November 2002. The drug is also used to treat bipolar disorder in adults. Through June 2007, Otsuka Pharmaceutical Co. Ltd. and Bristol-Myers Squibb report that U.S. doctors have written more than 12.5 million prescriptions for the drug.

The approval for teens is based on a clinical trial in which more than 300 teens undergoing an acute schizophrenia episode received one of two doses of Abilify (10 milligrams/day or 30 milligrams/day) or an inactive placebo. Both doses of Abilify improved schizophrenia symptoms better than the placebo.

Side effects seen in the study included extrapyramidal disorder (physical symptoms such as involuntary muscle movements, abnormal posture, and slurred speech), sleepiness, and tremor. These side effects were more common in teens taking higher doses of the drug.

However, side effects led to treatment discontinuation in only 5% of Abilify patients (and in 2% of placebo patients).

Weight gain is a typical side effect of older antipsychotic drugs, but it is far less common with atypical antipsychotics, including Abilify. One in 20 patients treated with Abilify had a 7% or greater weight gain.