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The U.S. Food and Drug Administration have approved Cymbalta for the maintenance treatment of generalized anxiety disorder in adults, Eli Lilly and Company announced.
"Since generalized anxiety disorder can be a chronic illness, it is important that doctors and their patients find a treatment option that is effective in both the acute and chronic phase of treatment," according James M. Martinez, MD, U.S. Medical Director for Cymbalta. "With this additional approval, Cymbalta suggests a new option for the maintenance treatment of this often-debilitating condition."
The safety and efficacy of Cymbalta for the maintenance treatment of GAD were established in a double-blind, placebo-controlled trial. Patients with GAD who initially had responded to treatment with Cymbalta 60-120 mg/day during a 26-week open-label phase were randomly assigned to receive placebo (213 patients) and Cymbalta 60-120mg/day (216 patients). At the end of the trial, patients taking Cymbalta manifested a statistically significantly longer time to relapse of GAD than did patients taking placebo. The estimated probability of relapse at 26 weeks of chronic treatment was 46.4 percent for placebo and 15 percent for Cymbalta. The most commonly reported treatment-emergent adverse events in patients taking Cymbalta in the open-label phase of the trial included dry mouth , nausea, headache, diarrhea, dizziness, constipation, fatigue and increased sweating.
"This Food and Drugs Administration approval, which is the sixth approval for Cymbalta, continues to validate the safety and efficacy profile of the medication in its approved indications," says Martinez.
Cymbalta also is approved for the acute and maintenance treatment of the management of diabetic peripheral neuropathic pain, major depressive disorder, fibromyalgia, and for the acute treatment of generalized anxiety disorder, all in adults.
Serotonin and norepinephrine in the spinal cord and brain are believed to both mediate core mood symptoms and help regulate the perception of pain. Based on preclinical studies, Cymbalta is a balanced and potent reuptake inhibitor of norepinephrine and serotonin that is believed to potentiate the activity of these chemicals in the central nervous system. While the mechanism of action of Cymbalta is not known, scientists believe its effects on anxiety and depression symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system.