Magazine article Clinical Psychiatry News

Olanzapine/fluoxetine Combination on the Way. (Bipolar Depression)

Magazine article Clinical Psychiatry News

Olanzapine/fluoxetine Combination on the Way. (Bipolar Depression)

Article excerpt

COLORADO SPRINGS -- Look for an olanzapine/fluoxetine combined formulation for treatment of bipolar depression to reach the marketplace in the next year or two, Dr. Willis Holloway said at a symposium on addictive disorders sponsored by Psychotherapy Associates.

Eli Lilly & Co. plans to file for Food and Drug Administration marketing approval for the combination in 2004. Chances for approval appear excellent, based not only on the favorable clinical trials data to date, but also on the promise of the olanzapine/fluoxetine combination to fill a gaping clinical need: There is no approved treatment for bipolar depression, explained Dr. Holloway, medical director of the human restoration program at Integris Mental Health in Oklahoma City and a member of the Eli Lilly speakers' bureau.

The absence of an FDA-approved therapy for bipolar depression is a huge deficiency. "Bipolar depression is really the burden of illness in bipolar disorder. It's the most difficult aspect of the disease to treat. Bipolar depressions tend to be very serious, long-lasting depressions," the psychiatrist said.

An Eli Lilly-sponsored, 8-week, double-blind, clinical trial reported last year compared olanzapine (Zyprexa) monotherapy, olanzapine plus fluoxetine, and placebo in 733 patients with bipolar depression. Olanzapine monotherapy proved significantly more effective than placebo as measured by improvement on the Montgomery-Asberg Depression Rating Scale. But the olanzapine/fluoxetine combination was significantly more effective than olanzapine monotherapy

The combination features either 6 or 12 mg of olanzapine plus 25 or 50 mg of fluoxetine formulated in a single tablet.

Antidepressant monotherapy is rarely used in bipolar depression because of the danger of a patient's relapsing into a manic episode. Current practice guidelines urge that a patient be on a mood-stabilizing agent before introducing the antidepressant, since this approach greatly decreases the risk of a switch to mama. …

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