Long-Acting Zyprexa Works,
But Has Sedation Risk, FDA Says

-Wall Street Journal

02/04/2008 -

The Food and Drug Administration said Monday 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 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.

Lilly is seeking FDA approval of the long-acting form of Zyprexa for the treatment of schizophrenia, which could be injected given every two or four weeks. The product would be administered in a doctor's office.

Schizophrenia is a chronic, severe and disabling brain disorder that affects the way people think and 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.

The FDA said the panel also will be asked to make recommendations about whether long-acting Zyprexa should carry a "black box" warning or if the agency should consider approving the product for so-called second line use after other drugs fail.

In documents also posted to FDA's Web site, Lilly said schizophrenia is a "chronic and devastating mental illness" and noted that "nonadherence with medication is common." The company said the injectable form of Zyprexa gives patients another treatment option.

Lilly said it believes the profound sedation associated with the long-acting injectable form of Zyprexa can be safely managed and said patients and health-care providers can be adequately warned of the risk.

The FDA said the sedation seen with the long-acting form of Zyprexa appears unique to the injectable form of the drug and likely results from the rapid release of the drug into a patient's body after being injected.

If you are currently taking Zyprexa and have concerns about its safetly, you should consult with your doctor regarding your treatment options. Under no circumstances should you discontinue taking any medication, including Zyprexa, without first consulting with your doctor. For Zyprexa legal information contact the Zyprexa Attorneys of Ennis & Ennis, P.A. by filling out our free Zyrpexa case evaluation form or by calling the toll-free number listed below.