Two Adolescent Indications Of Zyprexa Antipsychotic Medicine
A difficult topic has being discussed by the Committee of experts. The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) declared that Zyprexa (Olanzapine) drug is effective and safe in treating of schizophrenia or manic or mixed episodes associated with bipolar I disorder in patients aged 13-17 years old.
John Hayes, M.D., vice president of Lilly Research Laboratories suggested that the Committee vote is an important step in providing help and hope to the many young patients having severe mental illness.
In the review of the supplemental New Drug Applications FDA will take into consideration the panel’s recommendations and the advice of its Advisory Committees when deciding whether to approve new indications.
The panel voted for two proposed indications: for schizophrenia indication and for indication for manic or mixed episodes associated with bipolar I disorder.
It is known that the Committee scrutinized the results of two clinical trials of Zyprexa medication in adolescents with schizophrenia or bipolar I disorder.
The research lasted six weeks aimed to assess the efficacy and safety of Olanzapine tablets.
In studies included 72 adolescents (aged 13-17 years old) with schizophrenia and 107 adolescents (aged 13-17 years) with acute manic or mixed episodes associated with bipolar I disorder, patients taking Zyprexa 10 mg felt relevant improvements in their schizophrenia and bipolar symptoms.
Besides, the Committee reviewed safety data of Zyprexa medication significant to adolescents. The most common adverse events were increased weight, sedation and appetite. The types of adverse events observed in adults treated with Zyprexa schizophrenia medication were similar to those seen in adolescents.
Dr. Hayes agreed with the FDA that in many cases other available treatment options should be considered before Zyprexa drug when treating adolescents.
