Posted by Phillipa on August 20, 2010, at 20:15:12
Add to list chronic especially low back pain to list of uses for cymbalta, fibro and depression. Phillipa
From Medscape Medical News
FDA Panel Gives Mixed Blessing to Duloxetine for Chronic Pain
Fran LowryAugust 20, 2010 A US Food and Drug Administration (FDA) advisory committee has voted 8 to 6 in favor of Eli Lilly's request to broaden the indication for its antidepressant drug duloxetine (Cymbalta) to include the treatment of chronic pain.
The Anesthetic and Life Support Drugs Advisory Committee's marginal vote was a reflection of the ambiguity many members felt about the data presented by the sponsor in support of its request.
The panel felt that duloxetine was effective to treat chronic low back pain, showing its confidence by a vote of 8 to 5, with 1 panel member abstaining. But it voted 9 to 4, again with 1 abstention, against endorsing the drug for the treatment of osteoarthritis.
Already in use by 15 million people in the United States and approved to treat depression, diabetic nephropathy, and fibromyalgia, broadening the indication to include low back pain will likely result in a substantial increase in the prescribing of the product in the general population, "given the large number of Americans suffering from this type of chronic condition," Bob A. Rappaport, MD, director of the Division of Anesthesia and Analgesia Products of the FDA, reminded the panel.
Thomas Boyer, MD, from University of Arizona College of Medicine, Tucson, agreed that the data from the clinical trials presented by Lilly provided adequate evidence of efficacy for the management of chronic low back pain. He added that chronic low back pain "causes significant disability in the US and is poorly managed with the current pain medication."
Srinivasan Dasarathy, MD, from the Cleveland Clinic in Ohio, said he voted yes "because we should have some alternate treatments and duloxetine is not so bad."
Maria E. Suarez-Almazor, MD, PhD, from the University of Texas MD Anderson Cancer Center, Houston, agreed, adding that it is difficult to find alternative treatments for chronic low back pain.
There was some debate as to the different causes of low back pain and the degree of effectiveness of duloxetine given such variety, but Jeffrey R. Kirsch, MD, from Oregon Health & Science University, Portland, and chair of the panel, said he felt confident that a good relationship between physician and patient would allow for appropriate prescribing.
A dissenting vote came from Charles Rohde, MD, from Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, who said that the studies presented by Lilly were done mostly in whites and left out minorities. "There is ample evidence to suggest that certain minority populations do not follow the same patterns as a Caucasian population, and so by giving this a vote of yes, we would be saying it's fine for everyone and [I] don't believe that's been shown."
Gary Walco, MD, from Seattle Children's Hospital in Washington, who also voted no, added that the low back pain population is very heterogeneous and he would like to see more data on which patients would benefit the most from duloxetine.
Only 4 panel members felt that duloxetine showed benefit in the treatment of osteoarthritis.
Sorin Brull, MD, from Mayo Clinic College of Medicine, Jacksonville, Florida, was one. He said that the overall preponderance of the evidence suggested that duloxetine was at least as effective as the other available treatments for osteoarthritis and explained that his vote was based on noninferiority.
Dr. Boyer said he voted no because the 2 trials presented by Lilly were in conflict, with one showing positive results and the other showing negative results.
The panel was not too concerned about the drug's safety profile. Duloxetine is known to be hepatotoxic but so are a lot of other drugs. I would never prescribe anything if I was concerned about hepatotoxicity, said Dr. Dasarathy, a hepatologist. The hepatotoxicity with duloxetine is really not that bad.
All but 2 panel members felt that not enough evidence had been presented as to the safety of 120 mg of duloxetine in comparison with a 60-mg dose. But John Markman, MD, from the University of Rochester Medical Center in New York, disagreed.
"The evidence we say today does not strongly support the higher dose range, but I voted yes because in clinical practice there is enormous interindividual variation, and I do think there is a significant subpopulation who have incremental benefit over 60 mg, and I'd like to preserve access to that dose range for those patients," said Dr. Markman.
Dr. Dasarathy added that everyone increases the dose of a medication if it does not work. "Ultimately it is a decision of the physician and the patient."
Some panel members said they were concerned about the way that Eli Lilly has been marketing duloxetine, particularly on television. Dr. Kirsch told the FDA, "I think duloxetine will be a very useful drug for a significant number of patients and I think it's important to have it, but that said, I am personally perturbed by the marketing that goes on on television. The advertising ends with 'Depression is Painful'. I think that's an attempt of the sponsor to try to premarket this drug and for an indication that was not previously addressed until this point."
FDA Center for Drug Evaluation and Research Meeting of the Anesthetic and Life Support Drugs Advisory Committee, Bethesda, Maryland, August 19, 2010.
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