Eli Lilly and company submitted a supplemental new drug application (sNDA) to the US FDA for Cymbalta (duloxetine HCl) for the treatment of generalized anxiety disorder.

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 Alan Breier, VP - 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," he added.

Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core depression symptoms and help regulate the perception of pain. Disturbances of serotonin and/or norepinephrine may explain the presence of both the emotional and physical symptoms, including painful physical symptoms, of depression. Based on pre-clinical studies, duloxetine is a balanced and potent reuptake inhibitor of serotonin and norepinephrine. While the mechanism of action of duloxetine is not fully known, scientists believe its effect on both emotional symptoms and pain perception is due to increasing the activity of serotonin and norepinephrine in the central nervous system.

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.