Forest Laboratories Inc And Pierre Fabre Medicament Announce Third Positive Phase III Study For Levomilnacipran In Patients With Depressive Disorder

Forest Laboratories Inc and Pierre Fabre Medicament announced additional positive results from a Phase III clinical trial of levomilnacipran, an investigational agent for the treatment of adults with depressive disorder (MDD). Treatment with 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 III study of levomilnacipran in adults with MDD. Further analyses of the data are ongoing. The companies anticipate filing a new drug application with the FDA in the third quarter of the calendar year 2012. This was a randomized, double-blind, placebo-controlled, fixed-dose study evaluating the efficacy, safety and tolerability of levomilnacipran compared with placebo 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 40 mg or 80 mg once daily or placebo for eight weeks. This was followed by an additional 1-week double-blind down-taper period. All patients participating in the study met the criteria for recurrent 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 26 on the MADRS-CR. The average baseline score among participating patients was 31 on the MADRS-CR.