The U.S. Food and Drug Administration (FDA) has approved Cymbalta
(duloxetine HCl) for the management of Fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company announced today.
Cymbalta is the first serotonin- norepinephrine reuptake inhibitor with
proven efficacy for reducing pain in patients with Fibromyalgia.
The Fibromyalgia
indication represents the second FDA-approved use for Cymbalta for a pain
disorder, demonstrating the medication's analgesic effect.
"The approval of Cymbalta is important because it provides physicians and
patients with a new treatment option shown to help reduce pain and improve
functioning in this difficult-to-treat disorder," said Madelaine Wohlreich,
M.D., medical advisor and research physician at Lilly.
The cause of Fibromyalgia
remains unknown; however, scientists believe it may be related to some
combination of changes in brain and spinal cord chemistry,(i) genetics(ii) and
stress(iii). Some researchers believe Fibromyalgia
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 two naturally occurring substances called serotonin and norepinephrine. These
substances aid communication in many areas of the brain and spinal cord that
affect emotion. Research also suggests that these substances are part of the
body's natural pain-suppressing system.
"The FDA approval of Cymbalta for the management of Fibromyalgia
is another important step in the efforts to ensure that people with Fibromyalgia
will have the availability of effective medications to help reduce the chronic,
widespread pain of this life-altering disorder," said Lynne Matallana, president
of the National Fibromyalgia
Association and a Fibromyalgia
patient.