The US Food and Drug Administration (FDA) has approved duloxetine HCl delayed-release capsules (Cymbalta; Eli Lilly and Co) for the once-daily treatment of chronic musculoskeletal pain.
"Up to three quarters of the population experience chronic pain at some time in their lives," said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research, in an agency news release. "This approval means that many of those people now have another treatment option."
Regulatory approval followed a positive vote (8 - 5) in August from the FDA Anesthetic and Life Support Drugs advisory committee regarding the use of duloxetine to treat chronic low back pain. However, as reported by Medscape Medical News, the committee did not express the same confidence in the drug's usefulness as a treatment for osteoarthritis, voting 9 to 4 against its endorsement.
Concerns cited by members included duloxetine "noninferiority," rather than superiority, to currently available therapeutic options, as well as conflicting clinical trial results. In addition, most felt that not enough evidence had been presented as to the safety of the proposed 120-mg dose compared with the 60-mg dose.
According to the FDA news release, duloxetine has been approved for both chronic low back pain and osteoarthritis, based on data from 4 double-blind, randomized clinical trials showing that duloxetine was significantly more effective than placebo for decreasing pain in patients with those conditions. The recommended dose is 60 mg daily.
Treatment-emergent adverse events most commonly reported in patients with chronic musculoskeletal pain (incidence, 5% or higher — twice that of placebo) included nausea, dry mouth, insomnia, sleepiness, constipation, dizziness, and fatigue. Patients with osteoarthritis most commonly reported nausea, fatigue, and constipation.
Serious adverse events reported in less than 1% of duloxetine-treated patients include hepatotoxicity, allergic/hypersensitivity reactions, pneumonia, and suicidality.
Duloxetine delayed-release capsules previously were approved for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia.
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