Third Phase 3 Study Update of Levomilnacipran for MDD

Forest Laboratories and Pierre Fabre announced additional positive results from a Phase 3 clinical trial of levomilnacipran for the treatment of major depressive disorder (MDD). Levomilnacipran significantly reduced depression symptoms in patients with MDD compared to placebo, as measured by the Montgomery-Asberg Depression Rating Scale - Clinician Rated (MADRS-CR). This is the third, positive Phase 3 study of levomilnacipran in adults with MDD.

This was a randomized, double-blind, placebo-controlled, fixed-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, 568 men and women, 18–75 years of age, were randomized to receive either levomilnacipran 40mg or 80mg once daily or placebo for eight weeks. This was followed by an additional 1-week double-blind down-taper period. All patients had a minimum score of 26 on the MADRS-CR. The average baseline score among participating patients was 31 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: -3.3 (P=0.0027) and -3.14 (P=0.0043) in the 40 and 80mg groups, respectively. Statistically significant improvement was also seen in the Sheehan Disability Scale (SDS), the pre-specified key secondary efficacy parameter (placebo corrected difference: -1.83 (P=0.0459) and -2.72 (P=0.0028) in the 40 and 80mg groups, respectively).

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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