FDA Approves Cymbalta for Major Depressive Disorder
Posted on: Monday, 3 December 2007, 09:00 CST
US-based Eli Lilly and Company has received FDA approval for Cymbalta for the maintenance treatment of major depressive disorder in adults.
Cymbalta is a member of a class of drugs commonly referred to as serotonin and norepinephrine reuptake inhibitors.
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 60mg 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 Cymbalta experienced a statistically longer time to relapse of depression than did patients on placebo.
Doug Williamson, Cymbalta associate medical director for Eli 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."
The company said that treating the broad range of depression symptoms may minimize the presence of residual symptoms like anxiety, guilt and low self-esteem and can help delay the time to relapse.
Source: Datamonitor
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