FDA clears Cymbalta for fibromyalgia, 4th appro

The US Food and Drug Administration has approved Eli Lilly's Cymbalta (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder. The agent is the first serotonin-norepinephrine reuptake inhibitor with proven efficacy for reducing pain in patients with fibromyalgia.

This represents the second FDA-approved use for Cymbalta for a pain disorder, demonstrating the compound's analgesic effect, and is the fourth disorder that the FDA has cleared overall, says Lilly. In first-quarter 2008, Cymbalta earned $605.1 million, a 37% increase year-on-year, thanks to its use for the management of diabetic peripheral neuropathic pain, major depressive disorder and generalized anxiety disorder and this new indication is expected to expand sales further.

The cause of fibromyalgia remains unknown, however, scientists believe it may be related to some combination of changes in brain and spinal cord chemistry, genetics and stress. Some researchers believe it is a disorder of increased sensitivity to pain. Although the way Cymbalta works in people is not fully known, medical experts believe it increases the activity of serotonin and norepinephrine, which aid communication in many areas of the brain and spinal cord that affect emotion and are part of the body's natural pain-suppressing system.