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Dual Inhibitor Gets the Nod. The selective serotonin and norepinephrine dual reuptake inhibitor milnacipran (Savella, Forest Laboratories and Cypress Bioscience) received FDA approval for management of fibromyalgia. Two phase III trials of milnacipran 100mg/day and 200mg/day demonstrated statistically significantly and clinically meaningful concurrent improvements in pain, patient global assessment and physical function. In both studies, at three months a greater proportion of patients in the treatment arms experienced at least a 30 percent reduction in pain from baseline and rated themselves as "very much improved" or "much improved" on the PGA compared to controls, the companies report. Savella will hit pharmacy shelves next month.
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