Panel Approves Duloxetine for Lower Back Pain
BETHESDA, MD. — In a split vote, a Food and Drug Administration advisory panel voted 8-6 that the approved pain indications for duloxetine be expanded to include a broader population of patients with chronic pain.
However, in separate votes, the panel specifically recommended approving the drug for chronic low back pain but not for management of chronic pain from osteoarthritis.
The two adult patient populations considered for the expanded approval, based on data from five clinical studies submitted by duloxetine manufacturer, Eli Lilly & Co., were for those with chronic low back pain and those with chronic pain related to osteoarthritis.
Those voting in favor said they believed the drug could be a valuable treatment for patients with these conditions; those who did not support approval cited concerns that included questions about the strength of the studies.
But in two other separate votes, the panel split on whether the data from the 12- to 13-week clinical trials in the two groups of patients provided adequate evidence of efficacy for the two indications.
The panel voted 8-5 with 1 abstention that the clinical data provided enough evidence that duloxetine was effective in managing chronic low back pain.
Most of the panelists were not convinced by the data on the osteoarthritis pain indication, voting 9-4 with 1 abstention, that the two studies in OA patients did not provide adequate evidence that duloxetine was an effective treatment for chronic pain due to osteoarthritis–largely because only one of the studies found that treatment was significantly more effective in alleviating pain, compared with placebo.
Eli Lilly markets duloxetine, a serotonin and norepinephrine reuptake inhibitor (SNRI), as Cymbalta. It was previously approved for pain associated with diabetic peripheral neuropathy (2004) and fibromyalgia (2008).
It was first approved in 2004 for major depressive disorder, and also approved for generalized anxiety disorder (2007).