FDA Approves Duloxetine (Cymbalta) for Fibromyalgia

By Peggy Peck
INDIANAPOLIS, 17 june 2008-- The FDA has approved duloxetine (Cymbalta), a serotonin-norepinphrine reuptake inhibitor, for fibromyalgia, the drug-maker said today.
The Lilly antidepressant Duloxetine is the second drug to be approved for this indication. A year ago the FDA approved the seizure drug pregabalin (Lyrica) for fibromyalgia.Duloxetine is also indicated in adults for major depressive disorder, general anxiety, and peripheral diabetic neuropathy.
The added indication was approval on the basis of data from two three-month clinical trials of 874 fibromyalgia patients. In both studies, compared with placebo, duloxetine was associated with more than a 30% reduction in pain as measured by the Brief Pain Inventory (BPI) 24-hour average pain scale.
Moreover, patients randomized to duloxetine reported significant pain relief during the first week of treatment.
In both studies the majority of duloxetine patients -- 65% in one study and 66% in the other -- said they felt better since beginning treatment with 60 mg of duloxetine daily, as measured by a self-assessment (Patient Global Impression of Improvement).
The most commonly reported adverse events were nausea, dry mouth, constipation, decreased appetite, sleepiness, increased sweating, and agitation. Twenty percent of duloxetine patients discontinued the study drug because of adverse events versus 12% of placebo patients.
Duloxetine should not be taken by patients who are using or have recently used a monoamine oxidase inhibitor, patients taking thloridazine (Mellari) or patients with uncontrolled glaucoma. Severe and sometimes fatal liver problems have been reported among patients taking duloxetine. Duloxetine may increase the risk of hemorrhage among patients taking NSAIDs, aspirin, or other blood thinners.