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

d treatment options for prescribers and patients."

Indication Details:

  1. The new Symbyax TRD indication is for acute treatment of adult patients with major depressive disorder who have not responded to two separate trials of different antidepressants of adequate dose and duration in their current episode.
  2. Zyprexa, in combination with fluoxetine, is now approved for the acute treatment of TRD in adults.
  3. Symbyax was the first drug approved by the FDA for acute treatment of bipolar depression in adults in 2003. Zyprexa, in combination with fluoxetine, is now approved for the same indication.

With these FDA approvals, clinicians in the United States have the choice to use the single pill option (Symbyax), or the two drugs (Zyprexa and fluoxetine) together, allowing physicians to tailor treatment to each patient's needs. Neither Zyprexa nor fluoxetine are indicated as monotherapy for bipolar depression or TRD.

Additional Label Changes

In addition to the new indications, Lilly has updated the Symbyax and Zyprexa labels to include additional information regarding weight gain, hyperglycemia, and hyperlipidemia following the FDA's review of clinical trial data that Lilly submitted to the FDA between August 2007 and July 2008. In the course of this review, Lilly provided data from several large databases, including analyses of placebo-controlled data, comparator-controlled data, long-term data and special populations, including antipsychotic-naive patients.

Symbyax and Zyprexa in Combination with Fluoxetine Supportive Study Details for TRD

The data package submitted to the FDA supporting the approval of Symbyax for TRD as well as the approval of Zyprexa in combination with fluoxetine for TRD, included one pivotal trial and data from three supportive trials and one inco
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SOURCE Eli Lilly and Company
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