Cymbalta Reduces Pain and Improves Functioning in Fibromyalgia Patients

The U.S. Food and Drug Administration(FDA) has approved Cymbalta® (duloxetine HCl) for the management offibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company(NYSE: LLY) announced today. Cymbalta is the first serotonin-norepinephrinereuptake inhibitor with proven efficacy for reducing pain in patients withfibromyalgia. 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 theway Cymbalta works in people is not fully known, medical experts believe itincreases the activity of two naturally occurring substances calledserotonin and norepinephrine. These substances aid communication in manyareas of the brain and spinal cord that affect emotion. Research alsosuggests that these substances are part of the body's naturalpain-suppressing system.

"The FDA approval of Cymbalta for the management of fibromyalgia is anotherimportant step in the efforts to ensure that people with fibromyalgia willhave 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 fibromyalgiapatient.

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 painand tenderness. Some patients may have additional symptoms.(i) Althoughthere is no known cure for fibromyalgia, some physicians recommend acomprehensive care plan that can include education, medication, andlifestyle changes to help manage 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 themanagement of diabetic peripheral neuropathic pain (DPNP) and the treatmentof major depressive disorder and generalized anxiety disorder, all inadults age 18 years and older.

Additional important changes have been made to the Cymbalta prescribinginformation, including updates to the Warnings and Precautions section.Full prescribing 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. In both studies,Cymbalta reduced pain at study endpoint compared with placebo as measuredby the Brief Pain Inventory (BPI) 24-hour average pain scale.(vi) (vii) TheBPI is a scale that measures the severity of pain.

Significant improvement in pain for Cymbalta vs.