Phase 3 study of levomilnacipran for the treatment of major depressive disorder (MDD)
Forest Laboratories and Pierre Fabre announced preliminary top-line results from a Phase 3 study of levomilnacipran for the treatment of major depressive disorder (MDD). This was a randomized, double-blind, placebo-controlled, flexible-dose study in patients with MDD. Patients 18-80 years of age, who met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for MDD and a minimum score of 30 on the Montgomery-Asberg Depression Rating Scale-Clinician Rated (MADRS-CR) were eligible for enrollment in this study. The primary endpoint in the study was the MADRS-CR. Although the overall difference observed between the drug-treated and placebo-treated patients was not statistically significant, levomilnacipran consistently demonstrated improvement relative to placebo over the course of the trial.
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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