The US FDA Psychopharmacologic Drugs Advisory Committee has voted Eli Lilly’s Zyprexa (olanzapine) safe for use for adolescents suffering from bipolar I disorder and related episodes.
The FDA ruled that Zyprexa, an atypical antipsychotic, is effective and acceptably safe for the acute treatment of schizophrenia or manic or mixed episodes associated with bipolar I disorder in 13 to 17-year-olds.
Lilly Research vice-president John Hayes said the FDA committee’s vote was an important step toward providing help and hope to the many teens suffering from severe mental illness.
The committee examined results from two pivotal clinical trials of Zyprexa in adolescents with schizophrenia or bipolar I disorder including a six-week double-blind, placebo-controlled trial.
The six-week trial assessed the efficacy and safety of Zyprexa in 72 adolescents with schizophrenia.
A further three-week, randomised, double-blind, placebo-controlled trial assessed the efficacy and safety of Zyprexa in 107 adolescents with acute manic or mixed episodes associated with bipolar I disorder.
In these studies, adolescents taking Zyprexa experienced significant improvements in their schizophrenia and bipolar symptoms on various efficacy measures.