The FDA has approved duloxetine HCl (Cymbalta), a serotonin-norepinephrine reuptake inhibitor, for fibromyalgia patients.Duloxetine already was approved for management of diabetic peripheral neuropathic pain, as well as for treatment of major depressive disorder and generalized anxiety disorder. The FDA approved the new on-label use after three-month clinical trials involving 874 patients with fibromyalgia, who took 60 mg doses of duloxetine HCl. The results showed that 51% of patients in one trial and 55% in the other reported at least a 30% improvement on the Brief Pain Inventory (BPI) 24-hour average pain scale, and 65% and 66%, respectively, showed improvement at the study's endpoint, as measured by the Patient Global Impression of Improvement (PGI-I). In four pooled studies, the most commonly observed adverse events in fibromyalgia patients treated with duloxetine HCl were nausea, dry mouth, constipation, decreased appetite, sleepiness, increased sweating, and agitation.

Doctor's Guide News, "FDA Approves Duloxetine HCl for the Management of Fibromyalgia." 2008. www.docguide. com/news/content.nsf/news/85257102 0057CCF68525746A0050DBFD (16 June 2008).