Zyprexa for Maintenance of Bipolar Disorder Approved By FDA

First atypical antipsychotic approved for treatment of Bipolar mania is first mania treatment in 30 years to receive additional approval for Bipolar maintenance

(Jan. 15, 2004) -- The U.S. Food and Drug Administration (FDA) has approved Zyprexa (olanzapine) for maintenance in the treatment of bipolar disorder, Eli Lilly and Company announced today. This FDA approval recognizes that Zyprexa is an effective treatment to delay relapse into either mania or depression in patients with bipolar disorder. Zyprexa is the first treatment in nearly 30 years to be recognized by the FDA as a treatment for both acute mania and maintenance treatment in bipolar disorder.

"Bipolar disorder is a serious condition that can be difficult to treat. For those who achieve stability on existing medications, relapse of symptoms is all too common," said Frederick K. Goodwin, MD, Director, Center on Neuroscience, Medical Progress and Society, at the George Washington University Medical Center, Washington, D.C. "It is good news that the FDA has now approved Zyprexa as a new tool for physicians to use to delay relapse and prolong periods of stability and wellness."

Zyprexa was approved by the FDA in 2000 for the short-term treatment of acute mixed or manic episodes associated with bipolar disorder and is the first medication approved to both treat acute mania and delay relapse of symptoms associated with bipolar disorder since lithium received approval from the FDA in 1974. In addition, the FDA recently approved Symbyax for the treatment of bipolar depression. Symbyax combines the active ingredients in Zyprexa and Prozac, and is the first and only FDA-approved treatment for this devastating and difficult-to-treat phase of bipolar disorder.

Zyprexa Delayed Relapse Into Both Mania and Depression in Clinical Trials

The new indication is based on data from a double-blind, placebo-controlled study that showed time to relapse of either mania or depression was significantly longer for Zyprexa patients than patients treated with placebo. Zyprexa-treated patients had a significantly lower rate of either a mania (16.4 percent for Zyprexa versus 41.2 percent for placebo) or depression relapse (34.7 percent for Zyprexa versus 47.8 percent for placebo).

"We believe that physicians are looking for treatments, like Zyprexa, that demonstrate that they can effectively delay relapse, not only into the manic phase, but also into the depressive phase of bipolar disorder," said Mauricio Tohen, MD, Dr. P.H., Lilly clinical research fellow, Lilly Research Laboratories and Zyprexa product team leader. "This new indication provides a treatment option to clinicians and patients that is dependable in treating both acute manic episodes and delaying new episodes. Longer stable periods may provide greater opportunities for clinicians to work with their patients on improving work or family life."

In the placebo-controlled study, common and significant adverse events for the Zyprexa patients were weight gain, fatigue and inner and outer restlessness (akathisia).

SOURCE: Eli Lilly press release

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