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

al was inconclusive.
  • An integrated analysis of all five studies provided to the FDA yielded a statistically significant greater reduction in mean total MADRS scores from baseline to endpoint in the defined population for patients treated with Symbyax (-12.2) vs. fluoxetine (-8.5, p=0.015) and olanzapine (-7.7, p=0.007) and greater statistically significant remission rates (p=<0.05) for patients treated with Symbyax (25.5 percent), vs. fluoxetine (17.3 percent) and olanzapine (14.0 percent).
  • Adverse events that were reported in five percent or more of Symbyax-treated patients in these trials and at twice the rate of placebo were weight gain, increased appetite, dry mouth, somnolence and fatigue. This is consistent with the current safety information provided in the Symbyax label.

    Pivotal Studies for Bipolar Depression

    Approval was based on the results of two identical, eight-week, randomized, double-blind, controlled studies of patients diagnosed with bipolar depression. Zyprexa and fluoxetine in combination (6/25, 6/50, or 12/50 mg/day respectively) were compared to both Zyprexa alone (5 to 20 mg/day) and placebo. The primary outcome was symptom improvement based on the Montgomery-Asberg Depression Rating Scale (MADRS). Both trials showed that combination therapy with Zyprexa and fluoxetine resulted in a statistically significant greater improvement compared to Zyprexa alone and placebo.

    • In one eight-week controlled trial, combination therapy with Zyprexa and fluoxetine (n=42) was superior to both Zyprexa monotherapy (n=169) and placebo (n=174) in the reduction of the MADRS total score.
    • In a second eight-week controlled trial, combination therapy with Zyprexa and fluoxetine (n=40) was superior to both Zyprexa monotherapy (n=182) and placebo (n=181) in the reduction of MADRS total score.


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    SOURCE Eli Lilly and Company
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