Lilly schizophrenia drug has risk of deep sedation

Update to those who are psycho serious about psychopharmacology.


Lilly schizophrenia drug has risk of deep sedation
by Jennifer Corbett Dooren

Washington- the U.S. Food and Drug administration said yesterday that a long-acting, injectable form of Eli Lilly & Co.'s top-selling drug Zypreexa was effective at treating schizophrenia, but caused "profound sedation" in certain patients.

A memo written by Thomas Laughren, the FDA's psychiatry products division director, and posted on the agency's Web site yesterday, said clinical studies of the drug showed 24 out of 1915 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.

Zyprexia is currently approved as an oral, once-daily medication to ttreat 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, noncooperative 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 every two or four weeks. The product would be administered in a doctor's office.

Schizophrenia is a severe, 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 of 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 latge teens or 20s.

The FDA said the panel also will be asked to make recommendations about whether long-acting Zyprexa should carry a "blackbox" warning- the FDA's toughest drug precaution, which appears at the top of a product's label- or if the agency should consider approving the product for so called second line use after other drugs fail.

In documents also posted on the 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 witht he 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.


source: The Wall Street Journal, Feb. 5, 2008 p. 6