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Milnacipran Validated for Treatment of Fibromyalgia: Presented at AAPM By Emma Hitt, PhD HONOLULU -- January 30, 2009 -- Use of milnacipran 200 mg/day for up to 12 weeks appears to be safe and effective in a trial of patients with fibromyalgia, suggests a study presented here at the American Academy of Pain Medicine (AAPM) 25th Annual Meeting. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor. Milnacipran was approved for use in fibromyalgia in the United States in January 2009 for the treatment of fibromyalgia, making it the third medication approved for this purpose in the United States. Milnacipran is not yet approved in Europe. This current study, led by Mike Gendreau, MD, Cypress Bioscience, Inc., San Diego, California, investigated the efficacy and safety of milnacipran 200 mg, the highest dose approved, in treating fibromyalgia in a European population. Dr. Gendreau presented the results on January 29. A total of 884 patients from 83 sites across Europe with fibromyalgia were randomised to receive a 16-week regimen of milnacipran for 200 mg/day or placebo. At 16 weeks, compared with placebo, milnacipran significantly increased the primary efficacy endpoint of a composite score of pain and fibromyalgia scores (P = .0003). The Fibromyalgia Impact Questionnaire (FIQ) total score was also significantly improved (P = .015) as were other measures of pain, physical function, fatigue, and sleep quality. The most common adverse events associated with milnacipran were mild to moderate in severity and included nausea (26.0% vs 11.2%), hyperhidrosis (23.7% vs 2.9%), and headache (20.9% vs 14.8%). Funding for the study was provided by Pierre Fabry, Inc., which originally developed and sells milnacipran outside of the United States. [Presentation title: Milnacipran for the Treatment of Fibromyalgia Syndrome: A European Multicenter, Double-Blind, Placebo-Controlled Trial. Abstract 209] E-mail this page to a friend or colleague! To print, use this version