Posted by Phillipa on July 6, 2007, at 19:41:06
In reply to Requesting info. on this combo » Phillipa, posted by Squiggles on July 6, 2007, at 13:12:54
Squggles looked it up for you. Love Phillipa
FDA Approves Zyprexa for Use in Combination with Lithium or Valproate to Treat Acute Manic Episodes of Bipolar I Disorder
INDIANAPOLIS, IN -- July 16, 2003 -- Eli Lilly and Company announced July 15th that the U.S. Food and Drug Administration (FDA) has approved Zyprexa(R) (olanzapine) for use in combination with lithium or valproate (Depakote(R), Abbott) 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. Zyprexa was 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 Paul Keck, MD, professor of psychiatry, pharmacology and neuroscience, vice chairman for research, Department of Psychiatry, University of Cincinnati College of Medicine.
The FDA approval is 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.(1)
"Patients in manic episodes often have simultaneous depressive symptoms which can be very difficult to treat," said Dr. Keck. "Clinicians should welcome an FDA-approved combination therapy that helps them help these patients," he added.
"This new Zyprexa indication strengthens the substantial body of evidence showing that Zyprexa is a solid foundation for clinicians to use in their treatment of patients with acute bipolar mania," said Mauricio Tohen, M.D., Dr. PH., Lilly Clinical Research Fellow, Lilly Research Laboratories. "At Lilly, we are committed to the continued study of Zyprexa to help provide answers that matter to clinicians in the treatment of this devastating condition."
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(TM), an agent that combines Zyprexa with Prozac(R) (fluoxetine), is under FDA review for the treatment of bipolar depression. There is currently no FDA-approved treatment for bipolar depression.
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URL: http://www.dr-bob.org/babble/20070630/msgs/768153.html