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FDA approves Cymbalta for maintenance of major depression

The FDA approves US-based Eli Lilly's Cymbalta for the maintenance treatment of major depressive disorder in adults

The FDA has approved US-based Eli Lilly's Cymbalta (duloxetine) for the maintenance treatment of major depressive disorder (MDD) in adults.

The efficacy and safety of Cymbalta for maintenance treatment of major depression was established in a double-blind, placebo-controlled clinical trial. 

The trial assessed 533 patients with major depression, who received 60 mg of Cymbalta 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 six months.

Patients on the Cymbalta arm experienced a statistically longer time to relapse of depression than those receiving a 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.

Cymbalta is already approved for the acute treatment of major depressive disorder, the management of diabetic peripheral neuropathic pain, and for the treatment of generalised anxiety disorder in adults. More than nine million adults in the US have been prescribed the drug since approval.

Dr Doug Williamson, Cymbalta associate medical director for Lilly, said: "Relapse, the re-emergence of depressive symptoms after a successful treatment of depression, is a significant clinical concern. This approval from the FDA is important because data from our Cymbalta clinical trial demonstrate that continuing to treat the patient delays the time to possible relapse."

In Q3 FY07, sales of Cymbalta rose 47 per cent to reach USD 513.2m.

30th November 2007

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