Symbyax Approved For Treatment Resistant Depression
Eli Lilly announced today that the Food and Drug Administration (FDA) has given them approval to use Symbyax (Zyprexa-Prozac combination) to treat patients with treatment-resistant depression (TRD). Symbyax is the first drug approved by the FDA for the acute TRD in adult patients.
Symbyax was the first drug approved by the FDA for acute treatment of bipolar depression in adults in 2003. It is a combination of olanzapine (Zyprexa) and fluoxetine HCL (Prozac).
Neither Zyprexa nor Prozac are indicated as monotherapy (single drug therapy) for bipolar depression or treatment-resistant depression.
Bipolar depression is characterized by often debilitating mood swings that range from manic episodes to episodes of deep depression. The manic episodes are marked by abnormal euphoria, elation, and irritability. The deep depression episodes are marked by extreme sadness and difficulty in functioning.
Treatment-resistant depression is a condition when patients with depression fail to achieve adequate response to two separate trials of different antidepressants of adequate dose and duration in their current episode.
Eli Lilly notes that it 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 the company submitted to the FDA between August 2007 and July 2008.
Indication details for use of Symbyax for Treatment-resistant depression:
> Symbyax is indicated 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.
Previous developments in regard to treatment-resistant depression
>Eli Lily News Release