Europe Expresses Negative View For Cymbalta

Discussion in 'Fibromyalgia Main Forum' started by meowee, Oct 24, 2008.

  1. meowee

    meowee New Member

    INDIANAPOLIS, Oct. 24 -- 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.

    Source: Eli Lilly & Co.

  2. gapsych

    gapsych New Member

    Wasn't it Cymbalta that barely got approved to treat Fibromyalgia?

    I can see why as I do not know how it is any different than the other SSNRIs.

    As for the aches and pains that are mentioned, yes that can happen in depression but certainly not to the extent that people with Fibro. have.

    The commercial gives the message that they two conditions are the same.



  3. 3gs

    3gs New Member

    not in my mouth
  4. artkin

    artkin New Member

    Why refusal? This is the reason:

    The CHMP was concerned that the effectiveness of Cymbalta/Xeristar in treating fibromyalgia had not been shown sufficiently. In the short-term studies, the CHMP considered that the effect of Cymbalta/Xeristar was too small to be relevant for patients: there was no clear demonstration of improvement in symptoms, and the modest effects of Cymbalta/Xeristar could be due to the medicine’s effect of improving the patients’ mood. The CHMP also concluded that the long-term study was insufficient to show the effectiveness of the medicine and that a long-term study comparing Cymbalta/Xeristar with placebo would be needed.
    At that point in time, the CHMP was of the opinion that the benefits of Cymbalta/Xeristar in the treatment of fibromyalgia did not outweigh its risks. Hence, the CHMP recommended that the change to the marketing authorisation be refused.

    I remeber that also ramelteon was NOT approved in Europe for lack of effectiveness in insomnia patients. I think Europe commission is a more secure source than FDA. What do you think?