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News: Symbyax, a combination of Prozac and Zyprexa, approved for treatment-resistant depression


THE FDA HAS APPROVED fluoxetine (Prozac) plus olanzapine (Zyprexa) capsules (Symbyax) as therapy for treatment-resistent depression, defined as a failure to sustain or achieve remission from major depressive disorder (MDD), with two separate trials of different antidepressants of adequate dose and duration in the current episode. An estimated 35% of patients with MDD are afflicted with the treatment-resistant type. Labeling changes to the monographs for olanzapine and fluoxetine reflect the new indication, which allows the option to prescribe the single-pill treatment or two separate medications. The approval was made following two eight-week, double-blind clinical trials in which 40% of patients receiving the two-drug combination responded to therapy, compared with 30% of those receiving only fluoxetine, and 26% receiving only olanzapine.

Waknine Y. FDA approvals: Symbyax and Edluar. Medscape Web site. http://www.medscape.com/viewarticle/590209/. Published March 26, 2009. Accessed April 6, 2009.

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