Lilly submits Cymbalta application for generalized anxiety disorder

By Lisa Kerner

Erie, Pa., May 9 - Eli Lilly and Co. submitted a supplemental New Drug Application to the Food and Drug Administration for Cymbalta (duloxetine HCl) for the treatment of generalized anxiety disorder, according to a company news release.

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 said Cymbalta's effects on fibromyalgia, a chronic pain disorder, are also being studied in a phase 3 trial.

Scientists believe Cymbalta's effect on both emotional symptoms and pain perception is due to increasing the activity of serotonin and norepinephrine in the central nervous system.

"More than 3 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," vice president and chief medical officer Alan Breier stated in the release.

"Lilly is committed to fully exploring other unmet patient needs, and looks forward to conducting further research with this innovative drug."

About 4 million Americans age 18 to 54 are diagnosed with generalized anxiety disorder annually. People with generalized anxiety disorder commonly experience other physical and mental disorders, including depression, eating disorders or substance abuse.

Lilly is an Indianapolis-based pharmaceutical company.

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