The U.S. Food and Drug Administration has approved Cymbalta (duloxetine HCl) for the maintenance treatment of major depressive disorder (MDD) in adults according to the drug manufacturer, Eli Lilly and Company (NYSE:LLY).
The efficacy and safety of Cymbalta, as a maintenance treatment, was established in a double-blind, placebo-controlled clinical trial involving 533 patients with major depression. After 12 weeks, 278 patients met the criteria to continue in the trial and were randomly assigned Cymbalta or a placebo for the next six months. Those taking Cymbalta had a statistically longer period of time between relapses.
"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."
Cymbalta is a serotonin and norepinephrine reuptake inhibitor (SNRI) that was already approved for the treatment of acute major depressive disorder, the management of diabetic peripheral neuropathic pain and for generalized anxiety disorder in adults.
Full patient information on Cymbalta is available that includes side effects and contradictions.
[Source: PRNewsWire]
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» Eli Lily from PharmaGazette
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Tracked on: December 12, 2007 1:37 PM | Permalink to Trackback