ADELPHI, MD. — The atypical antipsychotic ziprasidone is effective for the treatment of manic or mixed episodes associated with bipolar disorder in patients aged 10-17 years, a Food and Drug Administration panel advised.
At a meeting in June, the Psychopharmacologic Drugs Advisory Committee voted 12-2 on ziprasidone's efficacy, with 4 abstentions. However, many on the 18-member panel abstained from voting on whether the data had shown the drug was acceptably safe in treating this population. Eight panel members voted in favor of safety, and one panelist voted no on this question. Among the reasons the nine panelists cited for abstaining was that a large number of patients were lost to follow-up in the study.
They also cited ambiguous data on an increase in QTc intervals among children treated with the drug, and the need for more data overall. Study data were presented by Pfizer, which manufactures ziprasidone (Geodon). The drug is already approved for treating schizophrenia and bipolar disorder in adults.
The panel was not asked specifically to rule on whether to recommend approval for treatment of the pediatric population. The FDA usually follows the recommendations of its advisory panels.
At the meeting, study results were presented on 238 patients, aged 10-17 years, with bipolar disorder (manic or mixed episodes) treated with placebo or ziprasidone (40-80 mg/day for those under 45 kg; 80-160 mg/day for those 45 kg or more). Based on the primary efficacy end point—change from baseline in the Young Mania Rating Scale after 4 weeks—there was a highly significant treatment effect similar to the changes observed in studies of adults, according to Pfizer.
Ziprasidone was generally well tolerated over 4 weeks, and for up to 26 weeks in an open-label study. The adverse event profile was similar to that seen in adults, with the exception of sedation and somnolence, which were more common in the pediatric population.
The rate of extrapyramidal symptoms was 24% among those on ziprasidone, compared with almost 8% among placebo. There were no completed suicides, and no increase in suicidality among those on ziprasidone.
In the short-term pediatric study, 3.6% of those on ziprasidone had a QTc interval increase of more than 450 msecs vs. 1.2% of those on placebo, Pfizer said.