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

Saturday, October 25, 2008 General News J E 4
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INDIANAPOLIS, Oct. 24 The Committee forMedicinal Products for Human Use (CHMP) of the European Medicines Agency(EMEA) has adopted a negative opinion on a Cymbalta(R) (duloxetinehydrochloride) application for the treatment of fibromyalgia.

"Eli Lilly and Company and Boehringer Ingelheim are naturally disappointedby the CHMP's opinion," said James Russell, M.D., global medical director forduloxetine, Eli Lilly and Company. "We remain confident in the duloxetinedata."

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

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

The cause of fibromyalgia remains unknown;(6) however, scientists believeit may be related to some combination of genetic disposition(7) and subsequentchanges in pain processing in the brain.(6) The disorder, which has aworldwide prevalence ranging from 0.5 percent to 5.0 percent of thepopulation,(8) has a high impact on quality of life. In addition to chronicwidespread musculoskeletal pain, many fibromyalgia patients experience othersymptoms such as tenderness, fatigue, sleep disturbance, anxiety anddepression.(1,9)

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

About Fibromyalgia

Fibromyalgia is difficult to diagnose, partly because no diagnostic testsfor the disease exist(10) and partly because a number of other conditions(both treatable and life-threatening) have similar symptoms.(10) To diagnosefibromyalgia, physicians apply pressure to a series of "tender points"throughout the body(9) and ask the patient if it feels painful. The AmericanCollege of Rheumatology (ACR) classification criteria for fibromyalgia are themost commonly used in clinical and therapeutic research.(11) The accepteddiagnostic criteria require that spontaneous pain be present for over threemonth'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 isbelieved to affect both serotonin and norepinephrine/noradrenaline mediatednerve signaling in the brain and the spinal cord. Based on pre-clinicalstudies, duloxetine is a reuptake inhibitor of serotonin andnorepinephrine/noradrenaline. Scientists believe its effect on pain perceptionis due to increasing the activity of serotonin and norepinephrine in thecentral nervous system.

Duloxetine is approved for the treatment of major depressive disorder anddiabetic peripheral neuropathic pain in many countries, and is approved insome countries for the treatment of stress urinary incontinence andgeneralised anxiety disorder. Duloxetine is approved only for adults 18 andover. There is a possibility of an increased risk of suicidal thoughts orbehaviour in children and young adults treated with antidepressants. Patientsshould call their doctor right away if they experience worsening depressionsymptoms, unusual changes in behaviour or thoughts of suicide, especially atthe beginning of treatment or after a change in dose.

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

Duloxetine is contraindicated in patients who are allergic to it, who haveliver disease resulting in hepatic impairment, who are taking a monoamineoxidase inhibitor (MAOI), fluvoxamine, ciprofloxacin or enoxacine or who havesevere kidney disease. The initiation of treatment with duloxetine also iscontraindicated in patients with uncontrolled hypertension that could exposepatients 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 along-term agreement to jointly develop and commercialize duloxetinehydrochloride. This partnership covers neuroscience indications in mostcountries outside of the United States and Japan, with few exceptions.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growingportfolio of best-in-class pharmaceutical products by applying the latestresearch from its own worldwide laboratories and from collaborations witheminent scientific organizations. Headquartered in Indianapolis, Ind., Lillyprovides answers -- through medicines and information -- for some of theworld's most urgent medical needs. For more information please visitwww.lilly.co.uk.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leadingpharmaceutical companies. Headquartered in Ingelheim, Germany, it operatesglobally with 135 affiliates in 47 countries and almost 38,900 employees.Since it was founded in 1885, the family-owned company has been committed toresearching, developing, manufacturing and marketing novel products of hightherapeutic value for human and veterinary medicine. In 2007, BoehringerIngelheim posted net sales of 10.9 billion euro while spending one fifth ofnet sales in its largest business segment Prescription Medicines on researchand development. For more information please visitwww.boehringer-ingelheim.com.

Duloxetine for major depressive episodes, diabetic peripheral neuropathicpain and generalised anxiety disorder is marketed by Lilly and BoehringerIngelheim in all countries included in the partnership under the brand nameCymbalta, except for Germany, Greece, Italy and Spain. In Germany, Lilly andBoehringer Ingelheim market duloxetine for major depressive episodes under thebrand name Cymbalta, and market the product for diabetic peripheralneuropathic pain as Ariclaim(R). In Greece, Italy and Spain Lilly markets theproduct as Cymbalta and Boehringer Ingelheim markets the product asXeristar(R). In the United States, Cymbalta is marketed by Lilly andQuintiles. In Japan, duloxetine is co-developed and co-marketed by Lilly andShionogi & Co., Ltd.

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

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

(2) Arnold, L, et al. A Randomized, Double-Blind, Placebo Controlled Trialof Duloxetine in the Treatment of Women with Fibromyalgia With orWithout Major Depressive Disorder. Pain. 2005; 119 (1-3): 5-15

(3) Arnold, L, et al. A Double-Blind, Multicenter Trial ComparingDuloxetine with Placebo in the Treatment of Fibromyalgia Patients With orWithout Major Depressive Disorder. Arthritis Rheum 2004; 50(9):2974-84.

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

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

(6) Leventhal, LJ. Management of Fibromyalgia. Annals of InternalMedicine. 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 ofFibromyalgia. Current Pain and Headache Reports 2001; 5:3320-329

(9) Epstein, SA, et al. Psychiatric Disorders in Patients withFibromyalgia. 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 theManagement of Fibromyalgia Syndrome. Ann Rheum Dis. Republished 2008: 67:536-541.

P-LLY

(Logo: http://www.newscom.com/cgi-bin/prnh/20070319/NYM004LOGO )Notes to Editors:

SOURCE Eli Lilly and Company
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