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FDA Approves Symbyax(R) as First Medication for Treatment-Resistant Depression
Date:3/23/2009

nclusive trial. The TRD-related label language includes efficacy data from three of these clinical studies (n=579). Acute safety information was based on a total of 10 studies. Doses evaluated in these studies ranged from 6-18 mg for olanzapine and 25-50 mg for fluoxetine in fixed combination.

  • An eight-week randomized, double-blind, controlled study was conducted to evaluate the efficacy of Symbyax 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 two antidepressants of adequate dose and duration in their current episode. Patients who were not responding to an antidepressant in their current episode entered an eight-week open-label fluoxetine lead-in, and then non-responders were randomized (1:1:1) to receive an eight-week trial of Symbyax, olanzapine, or fluoxetine. Symbyax was flexibly dosed between 6/50 mg, 12/50 mg, and 18/50 mg (olanzapine/fluoxetine dose). 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 Symbyax 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 Symbyax versus fluoxetine and olanzapine alone.
  • A third study demonstrated statistically significant greater reductions in total MADRS scores for Symbyax versus fluoxetine or olanzapine alone, when analyzed in a subpopulation of depressed patients (n=251) who met the same criteria for treatment resistance.
  • Although not cited in the approved label, two additional studies were included in the sNDA data package. One of the trials provided statistically significant supporting data for Symbyax in the acute treatment of TRD, while the other tri
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SOURCE Eli Lilly and Company
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