Cymbalta (duloxetine HCl) Approved For Chronic Musculoskeletal Pain Management
05 Nov 2010
The US Food and Drug Administration (FDA) has approved Cymbalta for chronic musculoskeletal pain - in other words, chronic back pain and osteoarthritis pain. According to Eli Lilly, the makers and marketers of Cymbalta (duloxetine HCI), this is the 5th indication for Cymbalta approved by the FDA. The medication is taken once a day.
Duloxetine, with brand names Cymbalta, Ariclaim, Xeristar and Yentreve is a serotonin-norepinephrine reuptake inhibitor. It is an effective drug for major depressive disorder and has been demonstrated in trials to be as effective as venlafaxine for GAD (generalized anxiety disorder). Submission for approval for stress urinary incontinence was turned down by the FDA because of liver concerns and suicidal events - it is, however, approved for this condition in Europe. The medication is also used for alleviation of pain symptoms linked to fibromyalgia and diabetic neuropathy.
Eli Lilly says Cymbalta has been demonstrated to considerably alleviate chronic low back pain and pain due to osteoarthritis. It is a non-narcotic pain reliever.
Michael Clark, M.D., MPH, director, Chronic Pain Treatment Program, Department of Psychiatry and Behavioral Sciences, The Johns Hopkins Medical Institutions, said:.
with chronic musculoskeletal pain often struggle to find a medication
that works for them. The approval of Cymbalta for chronic
musculoskeletal pain by the FDA gives doctors another option to help an
underserved and suffering group of patients
Experts believe Cymbalta works by raising brain and spinal cord levels of serotonin and norepinephrine, thus enhancing the body's natural pain suppressing system. However, nobody knows exactly how Cymbalta does this.
Side effects may include nausea, insomnia, sleepiness, constipation, dry mouth, fatigue and dizziness.
Robert Baker, M.D., global development leader for psychiatry and pain disorders at Lilly, said:
It's important that people with chronic musculoskeletal pain have different treatments available to them because responses to medications can be highly individualized. This is why we are happy to be able to provide doctors and patients with a new option.
Approximately 27 million American adults are affected by osteoarthritis. Up to 85% of them experience low back pain at some time; a tenth of whom are thought to eventually develop chronic low back pain.
Penney Cowan, executive director, American Chronic Pain Association, said:
Having a medication that is approved specifically for people with chronic musculoskeletal pain is a great step in helping these individuals live with less chronic low back pain or chronic pain due to osteoarthritis. Good medical care from a health care professional and involvement by the person with the condition is important.
Cymbalta has been approved in the USA for the following treatments:
- Major depressive disorder
- Generalized anxiety disorder
- Diabetic peripheral neuropathic pain
- Chronic musculoskeletal pain - i.e. chronic low back pain and chronic pain due to osteoarthritis
Cymbalta has not been approved for use with children.
Source: Eli Lilly, FDA