Forest Laboratories, Inc. and Pierre Fabre Laboratories announced that Forest has submitted a New Drug Application (NDA) to the FDA for levomilnacipran, a serotonin norepinephrine reuptake inhibitor for the treatment of Major Depressive Disorder (MDD) in adults. Levomilnacipran was discovered by Pierre Fabre and jointly developed by Forest Laboratories and Pierre Fabre, under a licensing agreement in the U.S. and Canada. Pierre Fabre will be the active pharmaceutical ingredient supplier.
The application includes results from three positive Phase III studies comprising two double-blind, fixed-dose studies and one flexible-dose study evaluating the efficacy of levomilnacipran compared with placebo in adults with MDD. A total of more than 1,600 adult patients received a once-daily dose of either levomilnacipran (40, 80, 120mg) or placebo in the three studies. In each of the three studies, statistically significant improvement was seen for the levomilnacipran group compared with placebo in the primary and secondary endpoints (change from baseline to endpoint in the Montgomery-Åsberg Depression Rating Scale total score and Sheehan Disability Scale total score, respectively) using the mixed-effects model for repeated measures and last-observation-carried-forward analyses.