Forest Laboratories and Pierre Fabre Medicament have announced additional positive results from a Phase III clinical trial of Levomilnacipran (1S, 2R-milnacipran), an investigational agent for the treatment of adults with major depressive disorder (MDD).
Developed by Forest Laboratories, Levomilnacipran is a once-daily sustained-release formulation, and a serotonin-norepinephrine reuptake inhibitor (SNRI).
The randomised double-blind placebo-controlled fixed-dose Phase III study was designed to evaluate the efficacy, safety and tolerability of Levomilnacipran compared with placebo in adult patients with MDD.
Following a one-week single-blind placebo run-in period, 568 men and women, 18-75 years of age, were randomised to receive either Levomilnacipran 40mg or 80mg once daily or placebo for eight weeks.
All patients 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 Montgomery-Asberg Depression Rating Scale - Clinician Rated (MADRS-CR), the primary efficacy parameter.
The study showed that the placebo-corrected mean change from baseline to end of week 8 in total MADRS-CR score was -3.3 and -3.14 and in the Sheehan Disability Scale (SDS), the secondary efficacy parameter was -1.83 and -2.72 in 40mg and 80mg groups, respectively.
Forest Research Institute Research & Development senior vice president Marco Taglietti said the third Phase III study further supports the potential of Levomilnacipran as an effective treatment option for adults with MDD.
Pierre Fabre Group Pharmaceutical Division president Frédéric Duchesne said the company believes that the efficacy and safety data in the three positive Phase III studies will support a successful New Drug Application (NDA) submission for Levomilnacipran in MDD in adult patients.
The companies plan to file an NDA with the US Food and Drug Administration in the third quarter of 2012.