Phase 3 Study Update of Levomilnacipran for Major Depressive Disorder

Forest Laboratories and Pierre Fabre announced top-line results from a Phase 3 clinical trial of levomilnacipran for the treatment of major depressive disorder (MDD). Treatment with levomilnacipran significantly reduced depression symptoms in patients with MDD compared to placebo, as early as week one and at each subsequent visit as measured by the Montgomery-Asberg Depression Rating Scale-Clinician Rated (MADRS-CR).

This was a randomized, double-blind, placebo-controlled, flexible-dose study evaluating the efficacy, safety and tolerability of levomilnacipran in adult patients with MDD. Following a 1-week single-blind placebo run-in period, 442 men and women, 18–80 years of age, were randomized to receive levomilnacipran 40mg–120mg once daily or placebo for 8 weeks. This was followed by an additional 2-week double-blind down-taper period. All patients participating in the study met the criteria for MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), and had a minimum score of 30 on the MADRS-CR. The average baseline score among participating patients was 35 on the MADRS-CR.

The placebo corrected mean change from baseline to end of week 8 in the primary efficacy parameter MADRS-CR total score using the Mixed-Effects Model Repeated Measure (MMRM) analysis was -3.1 (P=0.005). Statistically significant improvement was also seen in the Sheehan Disability scale (SDS), the pre-specified key secondary parameter (placebo corrected difference: -2.6, P=0.001).

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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