The FDA has approved the use of Eli Lilly and Company's [LLY] Zyprexa antidepressant as a combination therapy in bipolar I disorder.
The regulatory decision was based on data from two double-blind, randomized, placebo-controlled trials which showed that bipolar patients in manic or mixed episodes, treated with Zyprexa in combination therapy, demonstrated improved manic and depressive symptoms when compared to patients treated only with lithium or valproate alone.
Zyprexa (olanzapine) is now approved for use in combination with lithium or valproate (Depakote, Abbott [ABT]) for the treatment of acute manic episodes associated with bipolar I disorder. Zyprexa is the first agent to be approved for use in combination with other mood stabilizers to treat acute bipolar mania. The drug was first approved by the FDA in 2000 as a monotherapy for the short-term treatment of acute manic episodes associated with bipolar disorder and is the only atypical antipsychotic approved by the FDA to treat this patient population.
"Since bipolar mania is often challenging to treat and many patients do not respond rapidly or completely to a single agent, they are frequently treated with a combination of therapies," said Dr Paul Keck, professor of psychiatry, pharmacology and neuroscience and vice chairman for research in the department of psychiatry at the University of Cincinnati College of Medicine.
"Patients in manic episodes often have simultaneous depressive symptoms which can be very difficult to treat. Clinicians should welcome an FDA-approved combination therapy that helps them help these patients," added Dr Keck in a statement.
In addition to its approval more than three years ago for short-term treatment of acute bipolar mania, Zyprexa is currently under FDA review for long-term maintenance of response in the treatment of bipolar disorder. Additionally, Symbyax, an agent that combines Zyprexa with Prozac (fluoxetine), is under FDA review for the treatment of bipolar depression. There is currently no FDA-approved treatment for bipolar depression.