Forest Labs and Pierre Fabre's levomilnacipran positive in Ph III

US drugmaker Forest Laboratories (NYSE: FRX) and France-based Pierre Fabre have announced positive top-line results in a Phase III clinical trial of levomilnacipran, an investigational agent for the treatment of adults with major depressive disorder (MDD).

Treatment with levomilnacipran significantly reduced depression symptoms in patients with MDD compared to placebo, as early as week one and at each subsequent visit as measured by the Montgomery-Asberg Depression Rating Scale-Clinician Rated (MADRS-CR). This is the second, positive placebo-controlled Phase III study in this population. Further analyses of the data are ongoing. Results from an additional placebo-controlled Phase III fixed-dose study are expected in spring 2012.

FDA filing planned for later this year