Cymbalta for Chronic Pain — Lilly Resubmits FDA Application

Eli Lilly and Co. has resubmitted its application for FDA approval of Cymbalta for chronic pain. The drugmaker withdrew its application last November when FDA reviewers questioned statistical methodology and study design. The resubmission is based on a recently completed study in chronic pain due to osteoarthritis, the extension phase of a chronic low back pain study and previously completed studies in pain due to osteoarthritis and chronic low back pain. Studies in diabetic peripheral neuropathy pain and fibromyalgia support the resubmission as well.

According to Lilly, "Cymbalta is a potent reuptake inhibitor of serotonin and norepinephrine. Although the exact way that Cymbalta works in people is unknown, it is believed to be related to an increase in the activity of serotonin and norepinephrine, which are two naturally occurring substances in the brain and spinal cord. Cymbalta is approved in the United States for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia" -- all in adults at least 18 years old. Cymbalta is not approved for use in pediatric patients.

Related Resources:

• More About Cymbalta
• Quiz: Acute vs. Chronic Pain
• Cymbalta Approved for Fibromyalgia
• 10 Ways to Manage Osteoarthritis Pain
• Cymbalta Reduces Knee Osteoarthritis Pain

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