ARTICLE | Regulation

Run off the road

FDA reversal on Lilly's Cymbalta removes roadmap for drugs for chronic pain

August 23, 2010 7:00 AM UTC

Eli Lilly and Co. may have thought FDA had provided a roadmap that would have made Cymbalta duloxetine the first non-opioid and non-NSAID to be approved for a broad label for chronic pain. But the agency's about-face at last week's advisory committee meeting to discuss the sNDA implies FDA is divided on the issue and suggests it will be difficult for anyone to get such labeling.

Lilly's Cymbalta pain development program included trials in fibromyalgia and diabetic peripheral neuropathic pain, for which the selective serotonin and norepinephrine reuptake inhibitor (SSNRI) is already approved, plus chronic lower back pain and osteoarthritis (OA)...