FDA Approves Olanzapine, Fluoxetine HCl for Treatment-Resistant Depression

The US Food and Drug Administration (FDA) has approved olanzapine and fluoxetine HCl (Symbyax) capsules for the indication of acute treatment of treatment-resistant depression (TRD) in adult patients who have not responded to 2 separate trials of different antidepressants of adequate dose and duration in their current episode.

An 8-week randomised, double-blind, controlled study evaluated the efficacy of olanzapine and fluoxetine HCl 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 2 antidepressants of adequate dose and duration in their current episode.

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Treatment-Resistant Depression Affects Millions of Americans Each Year

Millions of Americans with depression are able to successfully manage their condition with a combination of available therapies. However, according to an article in the Journal of Clinical Psychiatry, up to 35 percent of patients treated for depression may have a little-known condition called Treatment-Resistant Depression, or TRD.

“There are evolving definitions of TRD among the research community, but at this point, a TRD diagnosis is usually given to a patient with major depressive disorder who has failed two adequate trials of an antidepressant medication,” said Dr. W. Clay Jackson, a primary care physician and assistant professor of clinical psychiatry at the University of Tennessee.

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