FDA OKs Abilify for Teen Schizophrenia
Abilify Now Second Schizophrenia Drug Approved for Teens
WebMD News Archive
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
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
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
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.