Positive Ph III results for Forest Labs and Pierre Fabre's levomilnacipran in major depressive disorder

US drugmaker Forest Laboratories (NYSE: FRX) and France’s third-largest pharma firm Pierre Fabre Medicament yesterday announced positive preliminary top-line results from a Phase III study of levomilnacipran for the treatment of adults with major depressive disorder (MDD). This is a boost for the companies which, early this year, presented disappointing late-stage trial results showing that the drug was no better than placebo in treating MMD.

Analyses of the latest data indicate a statistically-significant improvement was achieved for levomilnacipran treated patients for all dose groups compared to placebo on the primary efficacy endpoint which was change from baseline to end of week eight in the Montgomery-Asberg Depression Rating Scale-Clinician Rated (MADRS-CR) total score. Further analyses of the data are ongoing.

"Depressed patients often struggle to find the right antidepressant and the need for new medications is high. These positive Phase III results are very encouraging and support the continued research of levomilnacipran in adult patients with major depressive disorder," said Marco Taglietti, senior vice president, R&D and president, Forest Research Institute.