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European CHMP Adopts Negative Opinion on Cymbalta for the Treatment of Fibromyalgia

INDIANAPOLIS, Oct. 24 /PRNewswire-FirstCall/ -- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a negative opinion on a Cymbalta(R) (duloxetine hydrochloride) application for the treatment of fibromyalgia.

"Eli Lilly and Company and Boehringer Ingelheim are naturally disappointed by the CHMP's opinion," said James Russell, M.D., global medical director for duloxetine, Eli Lilly and Company. "We remain confident in the duloxetine data."

No medication has been approved in Europe for the treatment of fibromyalgia, a disease characterized by chronic widespread pain.

The CHMP received data on the use of duloxetine in the treatment of fibromyalgia in 1,411 patients in four placebo-controlled studies and 350 patients in one open-label safety study, a total of 1,761 patients in five clinical trials.(1,2,3,4,5)

The cause of fibromyalgia remains unknown;(6) however, scientists believe it may be related to some combination of genetic disposition(7) and subsequent changes in pain processing in the brain.(6) The disorder, which has a worldwide prevalence ranging from 0.5 percent to 5.0 percent of the population,(8) has a high impact on quality of life. In addition to chronic widespread musculoskeletal pain, many fibromyalgia patients experience other symptoms such as tenderness, fatigue, sleep disturbance, anxiety and depression.(1,9)

In Europe, duloxetine has been approved for the treatment of diabetic peripheral neuropathic pain (DPNP), major depressive episodes, generalised anxiety disorder (GAD) and stress urinary incontinence (SUI). Duloxetine was approved in the United States for the management of fibromyalgia in June 2008 by the U.S. Food and Drug Administration (FDA).

Notes to Editors:

About Fibromyalgia

Fibromyalgia is difficult to diagnose, partly because no diagnostic tests for the disease exist(10) and partly because a number of other conditions (both treatable and life-threatening) have similar symptoms.(10) To diagnose fibromyalgia, physicians apply pressure to a series of "tender points" throughout the body(9) and ask the patient if it feels painful. The American College of Rheumatology (ACR) classification criteria for fibromyalgia are the most commonly used in clinical and therapeutic research.(11) The accepted diagnostic criteria require that spontaneous pain be present for over three month's duration along the spine and in all four quadrants of the body.(10)

About Duloxetine

While duloxetine's mechanism of action in humans is not fully known, it is believed to affect both serotonin and norepinephrine/noradrenaline mediated nerve signaling in the brain and the spinal cord. Based on pre-clinical studies, duloxetine is a reuptake inhibitor of serotonin and norepinephrine/noradrenaline. Scientists believe its effect on pain perception is due to increasing the activity of serotonin and norepinephrine in the central nervous system.

Duloxetine is approved for the treatment of major depressive disorder and diabetic peripheral neuropathic pain in many countries, and is approved in some countries for the treatment of stress urinary incontinence and generalised anxiety disorder. Duloxetine is approved only for adults 18 and over. There is a possibility of an increased risk of suicidal thoughts or behaviour in children and young adults treated with antidepressants. Patients should call their doctor right away if they experience worsening depression symptoms, unusual changes in behaviour or thoughts of suicide, especially at the beginning of treatment or after a change in dose.

Patients taking duloxetine may experience dizziness or fainting upon standing. The most common side effects of duloxetine include:

-- For depression: Nausea, dry mouth, headache, insomnia, diarrhoea

-- For diabetic peripheral neuropathic pain: Nausea, somnolence

(sleepiness), fatigue, headache, dizziness

-- For generalised anxiety disorder: Nausea, fatigue, dry mouth,

drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis

(excessive perspiration), decreased libido, vomiting, ejaculation

delay and erectile dysfunction.

-- For stress urinary incontinence: Nausea, dry mouth, fatigue.

This is not a complete list of side effects.

Duloxetine is contraindicated in patients who are allergic to it, who have liver disease resulting in hepatic impairment, who are taking a monoamine oxidase inhibitor (MAOI), fluvoxamine, ciprofloxacin or enoxacine or who have severe kidney disease. The initiation of treatment with duloxetine also is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis.

Eli Lilly and Company and Boehringer Ingelheim

In November 2002, Eli Lilly and Company and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize duloxetine hydrochloride. This partnership covers neuroscience indications in most countries outside of the United States and Japan, with few exceptions.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. For more information please visit

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and almost 38,900 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. For more information please visit

Duloxetine for major depressive episodes, diabetic peripheral neuropathic pain and generalised anxiety disorder is marketed by Lilly and Boehringer Ingelheim in all countries included in the partnership under the brand name Cymbalta, except for Germany, Greece, Italy and Spain. In Germany, Lilly and Boehringer Ingelheim market duloxetine for major depressive episodes under the brand name Cymbalta, and market the product for diabetic peripheral neuropathic pain as Ariclaim(R). In Greece, Italy and Spain Lilly markets the product as Cymbalta and Boehringer Ingelheim markets the product as Xeristar(R). In the United States, Cymbalta is marketed by Lilly and Quintiles. In Japan, duloxetine is co-developed and co-marketed by Lilly and Shionogi & Co., Ltd.

Duloxetine for stress urinary incontinence is marketed by Lilly under the brand name Yentreve(R).

(1) Russell, IJ, et al. Efficacy and Safety of Duloxetine for Treatment of Fibromyalgia in Patients With or Without Major Depressive Disorder: Results From A Six-Month, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Trial, Pain. 2008.

(2) Arnold, L, et al. A Randomized, Double-Blind, Placebo Controlled Trial of Duloxetine in the Treatment of Women with Fibromyalgia With or Without Major Depressive Disorder. Pain. 2005; 119 (1-3): 5-15

(3) Arnold, L, et al. A Double-Blind, Multicenter Trial Comparing Duloxetine with Placebo in the Treatment of Fibromyalgia Patients With or Without Major Depressive Disorder. Arthritis Rheum 2004; 50(9):2974-84.

(4) Chappell, AS, et al. Duloxetine 60-120 mg Versus Placebo in the Treatment of Fibromyalgia Syndrome. Poster presented at the American College of Rheumatology Annual Meeting; Nov 2007, Boston, MA.

(5) Chappell, AS, et al. A 1-Year Safety and Efficacy Study of Duloxetine in Patients with Fibromyalgia. Poster presented at European League Against Rheumatism Annual Meeting; Jun 2008, Paris, France.

(6) Leventhal, LJ. Management of Fibromyalgia. Annals of Internal Medicine. 1999; 131: 850-858.

(7) Arnold, L, et al. Family Study of Fibromyalgia. Arthritis & Rheumatism. 2004; 50(3): 944-952.

(8) White, et al. Classification, Epidemiology, and Natural History of Fibromyalgia. Current Pain and Headache Reports 2001; 5:3320-329

(9) Epstein, SA, et al. Psychiatric Disorders in Patients with Fibromyalgia. Psychosomatics. 1999; 40(1):59

(10) Rao, SG, et al. Understanding the Fibromyalgia Syndrome. Psychopharmacology Bulletin. 2007: 4:24-67

(11) Carville, SF, et al. EULAR Evidence-based Recommendations for the Management of Fibromyalgia Syndrome. Ann Rheum Dis. Republished 2008: 67: 536-541.


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SOURCE Eli Lilly and Company
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