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FDA Approves Cymbaltaź for Maintenance Treatment of Major Depressive Disorder

INDIANAPOLIS, IN -- November 30, 2007 -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Cymbaltaź (duloxetine HCl) for the maintenance treatment of major depressive disorder (MDD) in adults.

Treating the broad range of depression symptoms may minimize the presence of residual symptoms (e.g., anxiety, guilt and low self-esteem) and can help delay the time to relapse(1). Common symptoms of depression can include sadness, loss of interest, fatigue, changes in appetite or weight, or bodily aches and pains.

"Once an episode of depression has been successfully treated, it is imperative that the symptoms do not return," said Lauren Marangell, M.D., an internationally recognized expert on depression and other mood disorders and a distinguished scholar at Lilly. "The American Psychiatric Association has recommended maintenance of antidepressant treatment to help decrease the chance of relapse."

The efficacy and safety of Cymbalta for maintenance treatment of major depression was established in a double-blind, placebo-controlled clinical trial. Patients with major depression in the trial (533 patients) received Cymbalta 60 mg once daily. After 12 weeks, 278 patients met the criteria for entering the continuation phase and were randomly assigned to either Cymbalta at the same dose or to a sugar pill for 6 months. Patients on Cymbalta experienced a statistically longer time to relapse of depression than did patients on placebo. Relapse was defined as an increase of two or more points on the Clinical Global Impression - Severity scale (CGI-S) compared with that obtained at week 12, and also meeting the criteria for major depressive disorder for two consecutive visits.

In this study, nausea was the most frequently reported side effect (also referred to as a treatment-emergent adverse event) during the acute phase and was reported as a reason for discontinuation for 2.1 percent of patients. In the continuation phase, there were no significant differences in reported side effects between patients taking Cymbalta compared with those taking sugar pills. Among patients who completed the first 12 weeks of the trial and entered the continuation phase, 3.6 percent reported side effects as reasons for discontinuation over the next 26 weeks (continuation phase) of the study.(2)

Cymbalta, a member of a class of drugs commonly referred to as serotonin and norepinephrine reuptake inhibitors (SNRI), has been studied in more than 27,000 patients worldwide. Cymbalta is already approved for the acute treatment of major depressive disorder, the management of diabetic peripheral neuropathic pain, and for the treatment of generalized anxiety disorder, all in adults. More than 9 million adults in the United States have been prescribed Cymbalta since approval.

REFERENCES:
(1) Nierenberg, A. Long-Term Management of Chronic Depression. J Clin Psychiatry 2001; 62 (Suppl 6):17-20.
(2) Perahia DG, et al. 2006. Duloxetine in the prevention of relapse of major depressive disorder: double-blind placebo-controlled study. Br J Psychiatry 188:346-353.


SOURCE: Eli Lilly and Company

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