Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved Cymbalta (duloxetine HCl) for the maintenance treatment of major depressive disorder (MDD) in adults.
"Relapse, the re-emergence of depressive symptoms after a successful treatment of depression, is a significant clinical concern," says Doug Williamson, M.D., Cymbalta associate medical director for Eli Lilly and Company. "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."
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. 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.