Eli Lilly is Seeking FDA Approval of Cymbalta For Chronic Pain

May 30, 2008 by  
Filed under ARTHRITIS

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A product of Eli Lilly, Cymbalta® – is a balanced and potent reuptake inhibitor of serotonin and norepinephrine, 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.

Though not approved for pediatric patients, 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 diabetic peripheral neuropathic pain, all in adults aged 18 and above.

Now, Eli Lilly has just submitted a supplemental New Drug Application (sNDA) to the US FDA seeking approval for a new indication for Cymbalta® (duloxetine HCl) — management of chronic pain.

According to the International Association for the Study of Pain (IASP), pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage. Chronic pain persists beyond acute pain or beyond the expected time for an injury to heal.

The said submission is based on outcomes of clinical trials in chronic osteoarthritis pain of the knee and chronic low back pain as well as data from previously completed pain studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia.

Some Patient Safety Information on Cymbalta®:

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 liver or kidney problems, glaucoma, or diabetes.

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. They also should talk to their doctor about their alcohol consumption. 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.

Visit Cymbalta.com for more information on Cymbalta®.

Source: Eli Lilly News

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4 Responses to “Eli Lilly is Seeking FDA Approval of Cymbalta For Chronic Pain”
  1. DuglasebiBus says:

    Любой текст 2 слова

  2. Annette Kreeutzer says:

    Let me clarify something. Cymbalta relieves the diabetic nerve pain in my legs. That is a blessing in itself! I also have osteoarthritis, as for as the pain from the arthritis is concerned, there is no pain relief. Thank you.
    Annette Kreutzer

  3. Annette Kreutzer says:

    I take CYMBALTA everyday. Every now and again I’ll forget to take it. I have pains that feel like I am being crushed and I am about to explode. AFTER FEW MINUTES, AFTER TAKING CYMBALTA, THE PAIN IS GONE! My problem is I am on MEDICAID, I think they believe I take it for depression, which I also suffer from! I am so afraid to not be able to afford my CYMBALTA! I can not go back to that pain, I don’t know what will become of me! For now I am very thankful that I am able to receive pain relief, which CYMBALTA GIVES ME! Thank you. Sincerely,
    Annette Kreutzer

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