The use of atypical antipsychotic agents continues to widen in the U.S. with approval of olanzapine for maintenance of bipolar disorder. The recent decision makes olanzapine the first treatment in almost 30 years to be approved for both acute mania and for maintenance therapy for bipolar disorder. Lithium became an option for both conditions in 1974.

"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. "It is good news that the FDA [Food and Drug Administration] has now approved Zyprexa as a new tool for physicians to use to delay relapse and prolong periods of stability and wellness."

The current approval is based on data from a double-blind, randomized study that showed time to relapse of either mania or depression was significantly longer for patients treated with olanzapine than for patients treated with placebo. Patients in the active treatment arm had a significantly lower rate of relapse into mania (16.4 percent for olanzapine versus 41.2 percent for placebo) or depression (34.7 percent for olanzapine versus 47.8 percent for placebo).

Mauricio Tohen, MD, PhD, noted "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."

More than 2.5 million Americans live with a diagnosis of bipolar disorder but recent research indicates the real number may be as high as 10 million people. The results of untreated bipolar disorder can be catastrophic. According to the National Institute of Mental Health, nearly 1 in every 5 affected people ends their life by suicide. The World Health Organization estimates that bipolar disorder is the sixth leading cause of disability in the world.