CYMBALTA is an antidepressant developed for the treatment of major depressive episodes and treatment of diabetic peripheral neuropathic pain in adults. CYMBALTA is a combined serotonin and noradrenaline reuptake inhibitor. It weakly inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors. Duloxetine dose-dependently increases extracellular levels of serotonin and noradrenaline in various brain areas of animals. CYMBALTA was studied in a clinical programme involving 2,951 patients (1,259 patient-years of exposure) meeting DSM-IV criteria for major depression. The approval was based on the results from six randomized, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder. CYMBALTA's efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of four out of the six studies.