EULAR and FDA Announce Fibromyalgia Advancements

Milnacipran appears effective; FDA approves Cymbalta

MONDAY, June 16 (HealthDay News) -- Milnacipran, a norepinephrine serotonin reuptake inhibitor, is an effective treatment for fibromyalgia syndrome, according to a study presented at the European League Against Rheumatism Congress 2008, held June 11 to 14 in Paris. And Eli Lilly's antidepressant Cymbalta (duloxetine) has now been approved by the U.S. Food and Drug Administration (FDA) to treat fibromyalgia. Like milnacipran, it has been shown to reduce pain levels compared to placebo.

Jaime Branco, M.D., of the EPE-Hospital Egas Moniz in Lisbon, Portugal, and colleagues randomized 884 fibromyalgia syndrome patients who did not have major depressive disorder to receive either placebo or milnacipran 200 mg/day for 12 weeks. The researchers used a composite response criterion and the Fibromyalgia Impact Questionnaire (FIQ) to assess the treatment's effect on symptoms. The primary efficacy endpoint was a composite responder rate based on a reduction of 30 percent or more in pain from baseline.

After three months, patients in the milnacipran group showed significantly more improvement than those in the placebo group in both the primary efficacy composite criterion and the FIQ total score. Milnacipran led to statistically significant improvements on multiple domains as compared to placebo, and it was well-tolerated, the researchers report.

"The responder/non-responder ratio for patients meeting criteria for composite response was significantly greater with milnacipran than placebo (odds ratio, 1.9)," the study's authors write. "These findings consistently confirm, on all relevant parameters, that milnacipran is an effective treatment for the multidimensional symptoms of fibromyalgia syndrome."

The milnacipran study was funded by Pierre Fabre Medicament, the maker of milnacipran, and Branco has disclosed financial ties to the company.

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