Agency Adds New Pain Indication for Duloxetine

Article excerpt

The Food and Drug Administration has approved the antidepressant duloxetine for the management of chronic musculoskeletal pain in adults, the agency announced.

The approval marks the fifth of duloxetine's U.S. licensed indications to date and its third for treatment of pain. Duloxetine, marketed as Cymbalta, was first approved in 2004 to treat depression, and later the drug gained indications for generalized anxiety disorder, diabetic neuropathy, and fibromyalgia. All of the indications are for people aged 18 years and older. The drug has received European Union marketing authorization for depression, anxiety, and diabetic neuropathy only.

The mechanism by which duloxetine, a serotonin and norepinephrine reuptake inhibitor, works on pain is uncertain, Eli Lilly said in a press statement accompanying the announcement. However, it is believed to increase the availability of both neurotransmitters, enhancing the body's natural pain-suppressing system.

In August the FDA's Anesthetic and Life Support Drugs Advisory Committee had voted 8-6 to recommend the extension of indication for duloxetine, a vote that was considered too narrow to predict what the agency would ultimately decide. …