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news.Eli Lilly has submitted a supplemental new drug application to the FDA seeking approval to market its antidepressant Cymbalta in an expanded indication of generalized anxiety disorder.
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Cymbalta is already approved in the US for the treatment of major depressive disorder and the management of diabetic peripheral neuropathic pain, both in adults.
Lilly is also conducting phase III studies on Cymbalta and its effects on fibromyalgia, a chronic, often debilitating pain disorder characterized by widespread muscle aches, pain and stiffness in muscles, and often accompanied by fatigue and sleep disturbance.
“More than three million patients worldwide have been treated with Cymbalta since its approval from the FDA for the treatment of major depression and management of diabetic nerve pain,” said Dr Alan Breier, vice president of Eli Lilly and Company. “Lilly is committed to fully exploring other unmet patient needs, and looks forward to conducting further research with this innovative drug.”