Use of olanzapine in Europe has now extended from acute treatment of mania to prevention of recurrent bipolar disorder. With its approval, olanzapine becomes the first atypical antipsychotic to enter mainstream practice as a mood-stabilizing agent.

"Bipolar disorder is a difficult-to-treat condition, and even when patients reach relatively stable periods of mood, relapse of symptoms is common and almost always inevitable," said Eduard Vieta, M.D., Ph.D. "With olanzapine’s [Zyprexa’s] new indication to prevent recurrence and stabilize moods, patients with bipolar disorder will now have a new option for breaking the cycle of relapse into the manic or depressive phases of the disorder and thus prolong periods of stability and wellness."

The European Commission based its approval on a review of six studies with more than 1,550 patients evaluating safety and efficacy in the prevention of recurrent bipolar disorder. Data from the trials included the finding that olanzapine was significantly more effective than lithium in delaying relapse, which reduced hospitalizations for that treatment arm and decreased the number of patients who discontinued therapy.

Additional data from a double-blind, placebo-controlled study showed time to relapse into either mania or depression was significantly longer for patients in the olanzapine group than for patients in a placebo group (median time to relapse, 174 days and 22 days, respectively).

"Olanzapine’s [Zyprexa’s] new indication as a mood stabilizing medication and its wide range of effectiveness in delaying relapses can help clinicians focus on the long-term management of the disorder, rather than just treating acute symptoms," said Mauricio Tohen, M.D., DrPH. "Recurrences can have devastating consequences for patients, who may experience disruptions in relationships and jobs, suffer feelings of failure or become suicidal. Prolonged periods of mood stability allow patients to have control of their lives, be productive and have a greater sense of well-being."