Levomilnacipran: Phase III data
Top-line data from a double-blind, flexible-dose, U.S. Phase III trial in 442 patients aged 18-80 with MDD showed that levomilnacipran met the primary endpoint of improving MADRS-CR total score from baseline to week 8 vs. placebo. Specifically, the placebo-corrected difference in mean change from baseline to week 8 in MADRS-CR total score was 3.1 points (p=0.005). Levomilnacipran also met the secondary endpoint of improving SDS score from baseline to week 8 vs. placebo (placebo-corrected difference of 2.6 points, p=0.001). Levomilnacipran was generally well tolerated with nausea, dizziness and constipation reported as the most common adverse events. Patients received once-daily 40, 80 or 120 mg levomilnacipran or placebo for 8 weeks, followed by an additional 2-week double-blind, down-taper period. The trial enrolled patients with a minimum total score of 30 on the MADRS-CR. ...