FDA News

FDA Okays Cymbalta for Maintenance Treatment of Major Depressive Disorder

(Dec 01, 2007)-- Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA)has approved Cymbalta (duloxetine HCl) for the maintenance treatment ofmajor depressive disorder (MDD) in adults.

"Relapse, the re-emergence of depressive symptoms after a successfultreatment of depression, is a significant clinical concern," says DougWilliamson, M.D., Cymbalta associate medical director for Eli Lilly andCompany. "This approval from the FDA is important because data from ourCymbalta clinical trial demonstrate that continuing to treat the patientdelays the time to possible relapse."

Treating the broad range of depression symptoms may minimize the presenceof residual symptoms (e.g., anxiety, guilt and low self-esteem) and can helpdelay the time to relapse. Common symptoms of depression can includesadness, loss of interest, fatigue, changes in appetite or weight, or bodilyaches and pains.

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

In this study, nausea was the most frequently reported side effect (alsoreferred to as a treatment-emergent adverse event) during the acute phase andwas reported as a reason for discontinuation for 2.1 percent of patients. Inthe continuation phase, there were no significant differences in reported sideeffects between patients taking Cymbalta compared with those taking sugarpills. Among patients who completed the first 12 weeks of the trial andentered the continuation phase, 3.6 percent reported side effects as reasonsfor discontinuation over the next 26 weeks (continuation phase) of thestudy.

Cymbalta, a member of a class of drugs commonly referred to as serotoninand norepinephrine reuptake inhibitors (SNRI), has been studied in more than27,000 patients worldwide. Cymbalta is already approved for the acutetreatment of major depressive disorder, the management of diabetic peripheralneuropathic pain, and for the treatment of generalized anxiety disorder, allin adults. More than 9 million adults in the United States have beenprescribed Cymbalta since approval.

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