Cymbalta Reduces Pain and Improves Functioning in Fibromyalgia Patients
INDIANAPOLIS, June 16 /PRNewswire-FirstCall/ -- The U.S. Food and DrugAdministration (FDA) has approved Cymbalta(R) (duloxetine HCl) for themanagement of fibromyalgia, a chronic widespread pain disorder, Eli Lilly andCompany (NYSE: LLY) announced today. Cymbalta is the first serotonin-norepinephrine reuptake inhibitor with proven efficacy for reducing pain inpatients with fibromyalgia. The fibromyalgia indication represents the secondFDA-approved use for Cymbalta for a pain disorder, demonstrating themedication's analgesic effect.
'The approval of Cymbalta is important because it provides physicians andpatients with a new treatment option shown to help reduce pain and improvefunctioning 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 itmay be related to some combination of changes in brain and spinal cordchemistry,(i) genetics(ii) and stress(iii). Some researchers believefibromyalgia is a disorder of increased sensitivity to pain. Although the wayCymbalta works in people is not fully known, medical experts believe itincreases the activity of two naturally occurring substances called serotoninand norepinephrine. These substances aid communication in many areas of thebrain and spinal cord that affect emotion. Research also suggests that thesesubstances are part of the body's natural pain-suppressing system.
'The FDA approval of Cymbalta for the management of fibromyalgia isanother important step in the efforts to ensure that people with fibromyalgiawill have the availability of effective medications to help reduce thechronic, widespread pain of this life-altering disorder,' said LynneMatallana, president of the National Fibromyalgia Association and afibromyalgia patient.
Fibromyalgia is estimated to affect 2 percent of the U.S. population -approximately 5 million people - the majority of those diagnosed beingwomen.(iv),(v) The disorder is characterized by chronic widespread pain andtenderness. Some patients may have additional symptoms.(i) Although there isno known cure for fibromyalgia, some physicians recommend a comprehensive careplan that can include education, medication, and lifestyle changes to helpmanage the symptoms of the disorder.(i)
'In fibromyalgia, there is no one-size-fits-all approach to managing thedisorder,' said Dan Clauw, M.D., professor of medicine in the University ofMichigan's Division of Rheumatology and director of the Chronic Pain andFatigue Research Center at the University of Michigan.
The approval marks the fourth disorder that the FDA has approved forCymbalta. In addition to fibromyalgia, Cymbalta is approved for the managementof diabetic peripheral neuropathic pain (DPNP) and the treatment of majordepressive disorder and generalized anxiety disorder, all in adults age 18years and older.
Additional important changes have been made to the Cymbalta prescribinginformation, including updates to the Warnings and Precautions section. Fullprescribing information can be found at www.cymbalta.com.
Data Highlights
Lilly established the efficacy of Cymbalta in two pivotal three-monthclinical trials involving 874 patients with fibromyalgia.
