Preliminary top-line results from levomilnacipran Phase III study for MDD

Forest Laboratories, Inc. and Pierre Fabre Medicament today announced preliminary top-line results from a Phase III study of levomilnacipran for the treatment of major depressive disorder (MDD). The primary endpoint in the study was the Montgomery-Asberg Depression Rating Scale-Clinician Rated (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 was well tolerated in this study. Overall, 80% of patients completed the study. Eight percent (8.0%) of patients prematurely discontinued the study due to adverse events in the levomilnacipran group compared to 2.2% in the placebo group. The most common adverse events in the levomilnacipran group were nausea and headache.

This Phase III study is part of the ongoing development program for levomilnacipran. Two additional placebo-controlled Phase III studies of levomilnacipran in patients with MDD are currently underway. Results from these studies are expected to be available in the second half of this calendar year.

These top-line results differ from previous findings in a 563 patient Phase II study of levomilnacipran, which demonstrated statistically significant improvement compared to placebo (p<0.0001) on the primary endpoint, change from baseline in total score on the MADRS.

Source: Forest Laboratories, Inc