FDA Approves Cymbalta for Fibromyalgia

FDA Approves Cymbalta for the Management of Fibromyalgia

Cymbalta Reduces Pain and Improves Functioning in Fibromyalgia Patients

INDIANAPOLIS, June 16, 2008 /PRNewswire-FirstCall/ -- 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.

Fibromyalgia is estimated to affect 2 percent of the U.S. population - approximately 5 million people - the majority of those diagnosed being women.(iv),(v) The disorder is characterized by chronic widespread pain and tenderness. Some patients may have additional symptoms.(i) Although there is no known cure for fibromyalgia, some physicians recommend a comprehensive care plan that can include education, medication, and lifestyle changes to help manage the symptoms of the disorder.(i)

"In fibromyalgia, there is no one-size-fits-all approach to managing the disorder," said Dan Clauw, M.D., professor of medicine in the Division of Rheumatology and director of the Chronic Pain and Fatigue Research Center at the .

The approval marks the fourth disorder that the FDA has approved for Cymbalta. In addition to fibromyalgia, Cymbalta is approved for the management of diabetic peripheral neuropathic pain (DPNP) and the treatment of major depressive disorder and generalized anxiety disorder, all in adults age 18 years and older.

Additional important changes have been made to the Cymbalta prescribing information, 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-month clinical trials involving 874 patients with fibromyalgia. In both studies, Cymbalta reduced pain at study endpoint compared with placebo as measured by the Brief Pain Inventory (BPI) 24-hour average pain scale.(vi),(vii) The BPI is a scale that measures the severity of pain.

Significant improvement in pain for Cymbalta vs. placebo was observed in the first week of each study. Fifty-one percent and 55 percent of patients on Cymbalta had a 30 percent improvement on the BPI at endpoint (clinically meaningful relief is considered at least 30 percent pain reduction(viii)).

In addition, 65 percent and 66 percent of patients taking Cymbalta 60 mg daily reported feeling better at endpoint as measured by the Patient Global Impression of Improvement (PGI-I). The PGI-I is a patient-rated scale that evaluates how much improvement has occurred since beginning treatment.

Cymbalta 60 mg was superior to placebo on the Fibromyalgia Impact Questionnaire (FIQ) Total Score. The FIQ is a scale that is used to assess and evaluate the impact of fibromyalgia on aspects of health and functioning believed to be most affected by the disorder.

In four pooled studies, the most commonly observed adverse events in Cymbalta-treated patients with fibromyalgia (greater than or equal to 5 percent and at least twice placebo) were nausea (29 percent), dry mouth (18 percent), constipation (15 percent), decreased appetite (11 percent), sleepiness (11 percent), increased sweating (7 percent) and agitation (6 percent). In the placebo-controlled clinical trials, the overall discontinuation rates due to adverse events for Cymbalta vs. placebo were 20 percent and 12 percent, respectively.(ix)

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Based on preclinical studies, Cymbalta is a balanced and potent reuptake inhibitor of serotonin and norepinephrine that is believed to potentiate the activity of these chemicals in the central nervous system (brain and spinal cord). While the mechanism of action of Cymbalta is not fully known, scientists believe its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system.

Cymbalta is approved in the United States for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, and the management of fibromyalgia and diabetic peripheral neuropathic pain in adults age 18 years and older. Cymbalta is not approved for use in pediatric patients.

Important Safety Information

Cymbalta is approved to treat major depressive disorder and generalized anxiety disorder, and to manage diabetic peripheral neuropathic pain and fibromyalgia. Antidepressants can increase suicidal thoughts and behaviors in children, adolescents, and young adults. Patients should call their doctor right away if they experience new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Cymbalta is approved only for adults 18 and over.

Cymbalta is not for everyone. Patients should not take Cymbalta if they have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking Mellaril(R) (thioridazine), or have uncontrolled glaucoma. Patients should speak with their doctor about any medical conditions they may have including kidney problems, glaucoma, or diabetes. Patients should talk to their doctor if they have itching, right upper belly pain, dark urine, yellow skin or eyes, or unexplained flu-like symptoms, which may be signs of liver problems. Severe liver problems, sometimes fatal, have been reported. They should also talk to their doctor about alcohol consumption. Patients should tell their doctor about all their medicines, including those for migraine, to avoid a potentially life-threatening condition. Taking Cymbalta with NSAID pain relievers, aspirin, or blood thinners may increase bleeding risk. Patients should consult with their doctor before stopping Cymbalta or changing the dose and if they are pregnant or nursing.

Patients taking Cymbalta may experience dizziness or fainting upon standing. The most common side effects of Cymbalta include nausea, dry mouth, sleepiness, and constipation. This is not a complete list of side effects.

If patients have any questions, they should talk to their doctor before taking Cymbalta.

For full Patient Information, visit www.cymbalta.com.

For full Prescribing Information, including Boxed Warning and medication guide, visit http://www.cymbalta.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and 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. Additional information about Lilly is available at www.lilly.com.

P-LLY

This press release contains forward-looking statements about the potential of Cymbalta for the management of fibromyalgia, and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

(i) Leventhal, LJ. "Management of fibromyalgia." Annals of Internal Medicine. 1999; 131: 850-858.

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

(iii) Bennett, Robert M., et al. "An Internet Survey of 2,596 People with Fibromyalgia." BMC Musculoskeletal Disorders. March 9, 2007. 8:27.

(iv) Lawrence, et al. "Estimates of the Prevalence of Arthritis and Other Rheumatic Conditions in the United States." Arthritis and Rheumatism. 2008; 58(1):31.

(v) Wolfe, F, et al. "The Prevalence and Characteristics of Fibromyalgia in the General Population." Arthritis and Rheumatism. 1995; 38(1):19-28.

(vi) 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; 119:14.

(vii) 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: In Press.

(viii) Farrar JT, JP Young Jr., L LaMoreaux, JL Werth, RM Poole. "Clinical Importance of Changes in Chronic Pain Intensity Measured on an 11-point Numerical Pain Rating Scale." Pain 2001; 94:149-158.

(ix) Cymbalta Prescribing Information

CONTACT: Sonja Popp-Stahly, Lilly, +1-317-655-2993 (office),+1-317-437-9947 (mobile), spopp-stahly@lilly.com

Ticker Symbol: (NYSE:LLY)

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Posted: June 2008

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