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

About Treatment-Resistant Depression

It is estimated that up to 35 percent of patients with depression - or approximately two percent of the general population - fail to achieve an adequate response to two respective antidepressant drug therapy attempts.(1) The exact causes of depression and why some people do not respond to initial pharmacological therapy is not known.(2)

About Bipolar Depression

Depressive episodes associated with bipolar I disorder (also known as bipolar depression) refers to the depressive phase of bipolar disorder, a complex mental illness characterized by debilitating swings in mood. The swings range from manic episodes, marked by abnormal euphoria, elation and irritability, to episodes of deep depression, marked by extreme sadness and difficulty functioning.(3)

Safety Information for Symbyax and Concomitant Use of Zyprexa and Fluoxetine

Symbyax is indicated in the United States for the acute treatment of bipolar depression and treatment-resistant depression in adults. Treatment-resistant depression is defined as major depressive disorder in adults who do not respond to two separate trials of different antidepressants of adequate dose and duration in the current episode.

Antidepressants can increase suicidal thoughts and behaviors in children, teens and young adults. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for worsening depression symptoms, unusual changes in behavior or thoughts of suicide. Patients and caregivers should be especially observant within the first few months of treatment or after a change in dose. Symbyax is not approved for children and adolescents.

Symbyax is not approved for the treatment of patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are a
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SOURCE Eli Lilly and Company
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