Dec. 29, 2003 — The FDA has approved Symbyax for the treatment of depression associated with bipolar disorder. Symbyax (pronounced SIMM-bee-ax), a combination of Zyprexa and Prozac, is the first FDA-approved medication for bipolar depression.

More than 2.5 million Americans live with a diagnosis of bipolar disorder, but recent research indicates the real number may be as high as 10 million.

Bipolar disorder is characterized by debilitating mood swings ranging from episodes of deep depression marked by feelings of extreme guilt, sadness, anxiety and, at times, suicidal thoughts to episodes of mania (abnormal euphoria, elation, and irritability), interspersed with periods of normal mood.

Patients with bipolar disorder spend more than three times longer in the depressive phase than in the manic phase of the disorder and take longer to recover from it. It is estimated that one in four people with bipolar disorder will attempt suicide at least once, and the risk of suicide among patients with bipolar depression has been shown to be nearly 35 times greater than for patients in the manic phase of bipolar disorder.



According to a study published in the November 2003 issue of Archives of General Psychiatry, Symbyax helped treat the symptoms of bipolar depression more effectively and at a significantly faster rate than placebo. In patients with bipolar depression, a manic episode is a potential consequence of treatment with a conventional antidepressant alone, but Symbyax patients had no greater risk of mania than patients taking placebo.



The most common side effect reported in patients taking Symbyax in clinical trials was drowsiness. Other common effects noticed were weight gain, increased appetite, feeling weak, swelling, tremor, sore throat, and difficulty concentrating.



High blood sugar, in some cases associated with coma or death, has been reported in patients taking antipsychotics such as Zyprexa. All patients taking Zyprexa and similar antipsychotic medications should be monitored for symptoms of high blood sugar.

SOURCE: News release, Eli Lilly and Co.