Cymbalta Under FDA Review for Chronic Pain
August 19, 2010 -- An FDA advisory committee will meet today to review whether the antidepressant Cymbalta should be used as a treatment for chronic pain, despite risks that include liver damage and skin disease.
Drugmaker Eli Lilly is seeking an indication for use in treatment of chronic pain, including pain related to arthritis and chronic low back pain.
In briefing documents posted on Tuesday, FDA reviewers said four studies found Cymbalta worked better than the placebo at easing pain, but they questioned one crucial aspect of Eli Lilly's study design, and pointed to a number of major safety concerns associated with Cymbalta.
Earlier this year, the agency took Lilly to task for making false and misleading claims in Cymbalta marketing materials, overstating efficacy of the drug against pain and minimizing its risks.
If the FDA approves Lilly's current application, it would "likely result in a substantial increase in the prescribing of the product in the general population given the large number of Americans suffering from these types of chronic pain conditions," wrote Dr. Bob Rappaport, director of the FDA's Division of Anesthesia and Analgesia Products in the briefing documents.
Many physicians say the decision likely won't change their prescribing habits, but an approval could expand insurance coverage.
"Insurance reimbursement of an antidepressant for pain will help patients who couldn't get access to the meds due to restrictive formularies and so may expand coverage that way," said Dr. Joan M. Von Feldt, a pain specialist at the University of Pennsylvania, in an e- mail.
Von Feldt added that many doctors are pleased to have non-narcotic options for chronic pain treatment, especially with the troubling trend of prescription opioid addiction.
Some, however, don't see the need for the alternative.
Dr. Nortin Hadler, an arthritis specialist at the University of North Carolina Chapel Hill, called the potential approval "a marketing ploy."
