The application includes results from three Phase 3 studies comprising two double-blind, fixed-dose studies and one flexible-dose study evaluating the efficacy of levomilnacipran compared with placebo in adults with MDD. A total of more than 1,600 adult patients received a once-daily dose of either levomilnacipran (40mg, 80mg, or 120mg) or placebo in the three studies. In each of the three studies, statistically significant improvement was seen for the levomilnacipran group compared with placebo in the primary and secondary endpoints (change from baseline to endpoint in the Montgomery-Åsberg Depression Rating Scale total score and Sheehan Disability Scale total score, respectively) using the mixed-effects model for repeated measures and last-observation-carried-forward analyses.
Levomilnacipran is a potent and selective inhibitor of the reuptake of norepinephrine and serotonin, two neurotransmitters known to play key roles in regulating mood. Levomilnacipran is a sustained-release formulation, dosed once-daily.
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