Tuesday, February 5, 2008

FDA Says Long-Acting Form of Zyprexa Effective, But Sedating

Article in the Wall Street Journal -- Lilly Gets Support for Version Of Schizophrenia Treatment, by Jennifer Corbett Dooren.  Here's an excerpt:

A Food and Drug Administration official said that a long-acting, injectable form of Eli Lilly & Co.'s top-selling drug Zyprexa was effective at treating schizophrenia, but caused "profound sedation" in certain patients.

A memo written by Thomas P. Laughren, the FDA's psychiatry products division director, and posted on the agency's Web site, 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.

The long-acting form of Zyprexa faces a review by an FDA panel of outside medical experts tomorrow. The panel will be asked if that 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 isn't required to.



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