Sunday, August 22, 2010

Cymbalta and Chronic Pain


FDA panel recommends allowing duloxetine to treat some chronic pain conditions.

The New York Times (8/20, B3, Wilson) reports that an FDA advisory panel "on Thursday voted narrowly to recommend allowing Eli Lilly to market its blockbuster antidepressant Cymbalta [duloxetine] for some chronic pain conditions like lower back ailments that affect millions of Americans." The panel "voted 8-6 in favor of expanding approved uses" but "voted against the drug's use for osteoarthritis." FDA officials at the meeting also "assured the panel they would draft warnings against the overuse of Cymbalta for pain, if they did finally approve a label change."
The Wall Street Journal (8/20, Dooren) notes that Cymbalta is currently approved to treat depression, diabetic nerve pain, fibromyalgia and anxiety. Bob Rappaport, director of FDA's anesthesia and analgesia products division, also said the agency is considering the approval of Cymbalta to treat musculoskeletal pain, including lower-back pain, but not for all types of chronic pain.
The AP (8/20, Perrone) adds that the "panelists picked apart five clinical studies submitted by the company, which showed conflicting results for the drug's effectiveness in different pain disorders and patient groups." Many panelists also "complained that Lilly's studies were primarily composed of older, Caucasian patients, raising questions about the drug's effectiveness in different age groups and ethnicities."

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