A combination pill containing olanzapine and fluoxetine (Symbyax) is the first of its kind to be Okayed for treatment resistant depression. The drug is approved for adults with major depressive disorder who have already tried two separate trials of antidepressants unsuccessfully. The drug combination, which can be prescribed as a single pill or as two separate pills, showed a significant reduction in depressive symptoms compared to baseline in light of five separate studies examining the drug’s effectiveness. The combination drug was also associated with greater remission rates. The following is an excerpt of an article from Medpage Today that discusses the drug more:
Information has also been added to the labels of olanzapine (Zyprexa) and fluoxetine indicating that the two drugs can be used in combination for the acute treatment of bipolar disorder and treatment-resistant depression.
Clinicians can prescribe the single-pill option or the two drugs in separate pills.
The approval of the treatment-resistant depression indication for the combination pill was made on the basis of data from one pivotal trial, three supportive studies, and one inconclusive trial using doses ranging from 6 to 18 mg for olanzapine and 25 to 50 mg for fluoxetine, Eli Lilly said.
An analysis of all five studies together showed a significant reduction in depressive symptoms from baseline with the combination pill compared with both fluoxetine (P=0.015) and olanzapine (P=0.007) alone.