Partners Forest Laboratories and Pierre Fabre Medicament said top-line results from a Phase III trial with levomilnacipran for the treatment of major depressive disorder (MDD) suggest the study has not met its primary endpoint. The data is in contrast to a previously completed, placebo-controlled Phase II trial, which showed that treatment using levomilnacipran led to statistically significant improvements in the Montgomery-Asberg Depression Rating Scale-Clinician-Rated (MADRS-CR).
The newly reported Phase III study took the form of a placebo-controlled, flexible-dose trial involving 362 adult MDD patients. After a one-week run-in period patients were randomized to receive either 40-120 mg of levomilnacipran once daily, or placebo, for eight weeks plus an additional two-week down-taper period. Topline results found that although levomilnacipran consistently led to improvements in MADRS-CR scores over the course of the trial, the differences between drug treatment and placebo were not statistically significant.
Two additional placebo-controlled Phase III studies with levomilnacipran in patients with MDD are ongoing. Results are expected during the second half of 2011.