FDA Approves Symbyax

Tuesday January 6, 2004

Lilly Announces FDA Approval of First Medication for Bipolar Depression

In a press release on December 29, 2003, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Symbyax (pronounced SIMM-bee-ax) for the treatment of depressive episodes associated with bipolar disorder. Symbyax is a combination of olanzapine, the active ingredient in Zyprexa, and fluoxetine, the active ingredient in Prozac. It is the first FDA-approved medication for bipolar depression.

"Medications that clinicians have traditionally used to treat bipolar patients in a depressive phase can often take several weeks to work and have the additional risk of sending the patient into a manic episode," said Ketter. "Having a medication that can provide symptom relief quickly, while avoiding mania, will be so important to physicians in effectively treating patients with bipolar depression, particularly because these individuals are at a high risk of suicide."

According to a study (Tohen, et al.) published in the November 2003 issue of Archives of General Psychiatry, Symbyax helped to treat the symptoms of bipolar depression more effectively and at a significantly faster rate than placebo. In the pooled eight-week studies, patients in the Symbyax group experienced significantly greater improvement in depressive symptoms at weeks one, three, four, six and eight, compared with patients taking placebo. That robust symptom improvement was sustained throughout the entire eight weeks of the study. In addition, Symbyax patients had no statistically greater risk of treatment-emergent mania than patients taking placebo.

"We are pleased to be able to provide clinicians with Symbyax, the first FDA-approved option to help physicians help their patients with bipolar depression," said Mauricio Tohen, M.D., Ph.D., Lilly clinical research fellow, Lilly Research Laboratories and Zyprexa product team leader. "Patients suffering from this debilitating condition can now benefit from the combination of the active ingredients in Zyprexa and Prozac, two of the most successful and proven medications in neuroscience history."
Read the full story from the Lilly Newsroom