Firms project NDA filing for levomilnacipran during the third quarter.
Pierre Fabre Medicament and Forest Laboratories reported positive data from a third Phase III trial evaluating levomilnacipran in the treatment of major depressive disorder (MDD) in adults. The firms say they project filing an NDA for the drug with FDA during Q3 2012. Positive data from the second Phase III study was reported in March.
The latest reported eight week Phase III study trial evaluated either a 40 mg or 80 mg dose of levomilnacipran or placebo in 568 patients with MDD. Results showed that levomilnacipran significantly reduced depression symptoms as measured by the Montgomery-Asberg Depression Rating Scale—Clinician Rated (MADRS-CR). Mean changes from baseline were -3.3 and -3.14 for the 40 mg and 80 mg patient cohorts, respectively.
Levomilnacipran (1S, 2R-minacipran) is an enantiomer of racemic milnacipran. The drug was discovered by Pierre Fabre and is licensed to Forest Laboratories for the U.S. and Canadian markets.