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FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications
Date:6/10/2009

rolled trial to assess the efficacy and safety of Zyprexa in 72 adolescents (aged 13-17 years old) with schizophrenia; and a three-week, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of Zyprexa in 107 adolescents (aged 13-17 years) 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. Symptoms of schizophrenia include acute episodes of delusions, hallucinations and long-term impairments such as diminished emotion, lack of interest and depressive signs and symptoms(1). Manic symptoms of bipolar I disorder include long periods of euphoria, restlessness, behaving impulsively and being easily distracted(2). A mixed bipolar state occurs when symptoms of depression and mania are experienced at the same time(3).

In addition to the two placebo-controlled studies, the Committee reviewed extensive Zyprexa safety data relevant to adolescents. Increased weight, appetite, and sedation were among the most common adverse events observed in adolescents. Weight gain was greatest in adolescents who were overweight or obese when they began treatment. Significant weight gain was also observed in patients who were of normal weight at baseline.

Although no clinical trials comparing adolescents to adults were conducted, data from the adolescent trials were compared to those from the adult trials. The types of adverse events observed in adolescents treated with Zyprexa were similar to those seen in adults. The incidence and magnitude of changes in weight, prolactin, triglyceride, cholesterol and hepatic enzyme levels were greater in adolescents than adults. Sedation was also more common in adolescents than adults.

"Because weight gain and some of the metabolic changes are more likely to occur and to be more prono
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SOURCE Eli Lilly and Company
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