Forest Laboratories and Pierre Fabre have unveiled positive late-stage data on their investigational depression drug levomilnacipran.
The companies have announced preliminary top-line results from their second 724-patient Phase III study of levomilnacipran for the treatment of adults with major depressive disorder. Analyses of the data indicate a statistically significant improvement was achieved for 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.
Marco Taglietti, head of R&D at Forest Research Institute, noted that depressed patients "often struggle to find the right antidepressant and the need for new medications is high". He added that these positive Phase III results "are very encouraging and support the continued research of levomilnacipran in adult patients with MDD".
This is a major boost for the firms given that the first 362-patient study, the results for which were published in January, found that levomilnacipran was no better than placebo in a late-stage trial to treat MDD. However, at the time, Forest and Pierre Fabre noted that the drug consistently showed improvement over placebo despite the results failing to reach statistical significance.
Results from two additional Phase III studies are expected at the end of this year and spring 2012, respectively.