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In January 2009, the FDA approved milnacipran (Savella), a selective serotonin and norepinephrine reuptake inhibitor, for treatment of fibromyalgia. In an industry-sponsored randomized trial, 1025 U.S. and Canadian patients with fibromyalgia (mean duration of symptoms, 11 years) received milnacipran or placebo. Dosing started at 12.5 mg once daily and was titrated to 50 mg twice daily over 3 weeks. Patients with major depression were excluded.
After 12 weeks of treatment at maximal dose, milnacipran recipients were significantly more likely than placebo recipients to show response on a primary composite outcome that included pain, physical function, and global impression. Because only 70% of patients completed the study, several types of int…