Phase 3 Study of Levomilnacipran for Major Depressive Disorder
Forest Laboratories announced results from its Phase 3 study of levomilnacipran for the treatment of adults with major depressive disorder (MDD). This was a randomized, double-blind, placebo-controlled, fixed-dose study evaluating the efficacy, safety, and tolerability of levomilnacipran in patients with MDD. Analyses of the data indicate a statistically significant improvement was achieved for levomilnacipran treated patients for all dose groups compared with placebo on the primary efficacy endpoint, which was change from baseline to end of Week 8 in the Montgomery-Asberg Depression Rating Scale-Clinician Rated (MADRS-CR) total score. Further analyses of the data are ongoing.
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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