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FDA Approves Olanzapine, Fluoxetine HCl for Treatment-Resistant Depression NEW YORK -- March 23, 2009 -- The US Food and Drug Administration (FDA) has approved olanzapine and fluoxetine HCl (Symbyax) capsules for the indication of acute treatment of treatment-resistant depression (TRD) in adult patients who have not responded to 2 separate trials of different antidepressants of adequate dose and duration in their current episode. An 8-week randomised, double-blind, controlled study evaluated the efficacy of olanzapine and fluoxetine HCl in patients (n=300) who met the fourth edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD) and did not respond to 2 antidepressants of adequate dose and duration in their current episode. Patients who were not responding to an antidepressant in their current episode entered an 8-week open-label fluoxetine lead-in, and then non-responders were randomised (1:1:1) to receive an 8 weeks of olanzapine and fluoxetine, olanzapine alone, or fluoxetine alone. Results from this study yielded a greater statistically significant reduction in mean total Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline to endpoint for olanzapine plus fluoxetine versus fluoxetine and olanzapine alone. A second study of 28 patients who met the same criteria for TRD demonstrated statistically significant greater reductions in MADRS scores for olanzapine plus fluoxetine versus fluoxetine and olanzapine alone. A third study demonstrated statistically significant greater reductions in total MADRS scores for olanzapine plus fluoxetine versus fluoxetine or olanzapine alone, when analysed in a subpopulation of depressed patients (n=251) who met the same criteria for treatment resistance. Adverse events that were reported in 5% or more of olanzapine/fluoxetine -treated patients in these trials and at twice the rate of placebo were weight gain, increased appetite, dry mouth, somnolence, and fatigue. SOURCE: Eli Lilly and Company E-mail this page to a friend or colleague! To print, use this version