Narrow Vote Recommends Eli Lilly's Cymbalta for Chronic Pain
A scientific advisory panel to the US Food and Drug Administration (FDA) voted narrowly (8 to 6) to recommend allowing Eli Lilly to market the antidepressant drug Cymbalta for some chronic pain conditions. Advisory committee votes are often – but not always – followed by the agency.
Eli Lilly Will Continue to Seek Expanded Pain Use for Cymbalta
Cymbalta (generic name duloxetine) is currently approved for major depression, diabetic nerve pain, generalized anxiety disorder, and fibromyalgia.
The Anesthetic and Life Support Drugs Advisory Committee, in a series of votes, approved the drug’s effectiveness for the relief of chronic lower back pain, but it voted against using Cymbalta for osteoarthritis pain relief. Dr. Robert Baker, Eli Lilly’s global development leader for psychiatry and pain disorders, said that the company would continue to seek FDA approval to market Cymbalta to treat all chronic pain.
To support its application for approval, Eli Lilly submitted three trials testing various doses of Cymbalta against a placebo in 1,041 chronic low-back pain patients. In all three, duloxetine demonstrated a greater pain reduction as measured by the 11 point Brief Pain Inventory and patient diaries. The company also submitted data from two trials of 487 osteoarthritis patients. Only one of the trials found that duloxetine eases arthritis pain better than placebo.
The news wasn’t all good for Cymbalta. The panel also criticized Eli Lilly for its advertising campaign “Depression is Painful.” Panel chair Dr. Jeffrey Kirsch MD called it an attempt to premarket the drug for unapproved pain use.
If the FDA ultimately approved Cymbalta for chronic pain, officials have assured the panel that there would be warnings against the overuse of Cymbalta. The drug is known to be mildly hepatotoxic, for example. Duloxetine has also been associated with an increased risk of Stevens-Johnson Syndrome, a skin disease that usually results from a drug reaction.
Cymbalta may not work for every patient, warns panelist John Markman MD, director of the Neuromedicine Pain Management Center at the University of Rochester Medical Center. He estimates that for every 10 patients treated with duloxetine, just one would experience a 30% reduction in pain.
Over 14 million prescriptions for Cymbalta were written last year, according to an FDA report. About 400,000 of them were for off-label uses, including musculoskeletal pain, headaches, or nerve pain.