Ely Lilly announced that it plans to seek FDA approval to market its Cymbalta depression drug for the treatment of generalized anxiety disorder (GAD). Backed by data from two clinical trials that support Cymbalta's use in the treatment of GAD, Lilly plans to submit the application to the Food and Drug Administration (FDA) next year.
Approved in August of 2004 for use in the treatment of major depression, Cymbalta was also approved in the treatment of diabetic peripheral nerve pain in September 2004. The move for approval in treatment of GAD is due in part to sales that have lagged behind initial predictions.
Generalized anxiety disorder is a condition which generally affects women and lasts for at least six months, is characterized by symptoms such as exaggerated worry, chronic anxiety and irritability. It is also often accompanied by physical symptoms such muscle tension, restlessness and insomnia.
According to Lilly, the condition is also implicated in related disorders, such as depression, eating disorders and substance abuse.
Cymbalta alleviates the symptoms of depression by increasing the activity of serotonin and norepinephrine in the central nervous system by inhibiting re-uptake of the chemicals into neurons, prolonging their effects. The abnormal functioning of serotonin and norepinepherine are both believed to underlie the symptoms of depression.
Cymbalta functions similarly to Paxil and Effexor, the world's top selling depression treatment.
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