Microsoft word - fda approves cymbalta
Eli Lilly and CompanyLilly Corporate CenterIndianapolis, Indiana 46285U.S.A.
June 16, 2008
Sonja Popp-Stahly, Lilly
317-655-2993 (office)317-437-9947 (mobile)
FDA Approves Cymbalta® for the Management of Fibromyalgia
Cymbalta Reduces Pain and Improves Functioning in Fibromyalgia Patients
INDIANAPOLIS – 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 (NYSE: LLY) 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 chemistrygeneticand stressSome
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 womeThe 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
"In fibromyalgia, there is no one-size-fits-all approach to managing the disorder," said Dan
Clauw, M.D., professor of medicine in the University of Michigan’s Division of Rheumatology
and director of the Chronic Pain and Fatigue Research Center at the University of Michigan.
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
Additional important changes have been made to the Cymbalta prescribing information,
including updates to the Warnings and Precautions section. Full prescribing information can be
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
scaleThe 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
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
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 (≥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
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
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®
(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
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
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
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.
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iv Lawrence, et al. “Estimates of the Prevalence of Arthritis and Other Rheumatic Conditions in the United States.”Arthritis and Rheumatism
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vi Arnold, L. et al. “A Randomized, Double-Blind, Placebo Controlled Trial of Duloxetine in the Treatment ofWomen with Fibromyalgia With or Without Major Depressive Disorder.” Pain
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vii Russell IJ, et al. “Efficacy and Safety of Duloxetine for Treatment of Fibromyalgia in Patients With or WithoutMajor 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 PainIntensity Measured on an 11-point Numerical Pain Rating Scale." Pain
ix Cymbalta Prescribing Information
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