FDA claims, Zyprexa is effective, but causes sleepiness

By Anastasia Tomazhenkova: The FDA claimed that longer-lasting injectable version of Eli Lilly's schizophrenia drug, Zyprexa, appears effective, though a small number of patients experienced excessive sleepiness.

The Food and Drug Administration posted its review of Zyprexa Adhera ahead of a Wednesday panel meeting, where psychiatric drug advisers will vote on whether the drug is safe and effective.

Zyprexa is currently available as a once-daily pill to treat schizophrenia and bipolar disorder. The new formulation is injected into the muscle and is designed to last two to four weeks.

FDA will ask its outside experts to assess incidents of "profound sedation," seen in about one percent of patients injected with the drug. Most of the reports of sedation occurred one to three hours after injection.

A memo written by Thomas P. Laughren, the FDA's psychiatry products division director, and posted to the agency's Web site Monday said clinical studies of the drug showed 24 out of 1,915 patients exposed to the long-acting form of Zyprexa suffered from profound sedation after receiving the injection. The FDA said the sedation typically lasted about one to three hours and affected about 1% of patients given the injection.

The long-acting form of Zyprexa faces a review by an FDA panel of outside medical experts Wednesday. The panel will be asked if the long-acting form of Zyprexa has been shown to be "acceptably safe" and effective for the treatment of schizophrenia. The panel's decision will amount to a recommendation about whether the FDA should approve the product. The FDA usually follows its panel's advice but is not required to.

Zyprexa is approved as an oral, once-daily medication to treat schizophrenia and bipolar disorder. The drug had $4.8 billion in sales last year. There is also a short-acting injectable form of Zyprexa that is used to treat agitated, non-cooperative patients with schizophrenia or bipolar mania, usually in an emergency setting.

Sales of Zyprexa were $1.67 billion in the last quarter of 2007. Shares of Eli Lilly & Co. fell 16 cents Monday to $51.50.

Schizophrenia is a psychiatric diagnosis that describes a mental illness characterized by impairments in the perception or expression of reality, most commonly manifesting as auditory hallucinations, paranoid or bizarre delusions or disorganized speech and thinking in the context of significant social or occupational dysfunction. Onset of symptoms typically occurs in young adulthood, with approximately 0.4–0.6% of the population affected. Diagnosis is based on the patient's self-reported experiences and observed behavior. No laboratory test for schizophrenia exists.

Studies suggest that genetics, early environment, neurobiology and psychological and social processes are important contributory factors. Current psychiatric research is focused on the role of neurobiology, but a clear organic cause has not been found.

Schizophrenia afflicts about 1% of Americans. According to the National Institute of Mental Health, people with schizophrenia may hear voices other people don't hear or they may believe that others are reading their minds, controlling their thoughts or plotting to harm them. The disorder is typically diagnosed in a person's late teens or 20s.

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