Lilly submits Cymbalta NDA for generalized anxiety disorder

May 10 2006

Eli Lilly and Company has announced the recent submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Cymbalta (duloxetine HCl) for the treatment of generalized anxiety disorder.

Cymbalta is already approved in the United States 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 Alan Breier, M.D., vice president - medical and chief medical officer, 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."

Every year four million Americans age 18 to 54 are diagnosed with generalized anxiety disorder, the majority of them women. It is common for people with generalized anxiety disorder to also experience other physical and mental disorders, including depression, eating disorders or substance abuse.(iii) Because generalized anxiety disorder presents with a variety of symptoms, both anxious and physical, it can be difficult to diagnose.(iv) When left untreated, symptoms may get progressively worse, significantly diminishing a patient's quality of life.