Pierre Fabre, Forest Report Positive Phase III Data from Depression Study
Firms plan to file for FDA approval of levomilnacipran by year end.
Pierre Fabre Medicament and Forest Laboratories reported positive data from a second Phase III study evaluating levomilnacipran in the treatment of adults with major depressive disorder (MDD). Data from the first Phase III study was reported in July 2011, and a third fixed-dose study is due to report before the summer. Pierre Fabre projects filing for approval of levomilnacipran in MDD with FDA by the end of 2012.
The latest data relate to a placebo-controlled, flexible-dose study involving 442 male and female adult patients with MDD. Participants were randomized to receive levomilnacipran 40–120 mg or placebo once daily for eight weeks, followed by another two-week down-taper period. Results showed that compared with placebo, levomilnacipran therapy led to statistically significant improvements in mixed-effects model repeated measure (MMRM) scores and the Sheehan Disability Scale (SDS) scores.
Levomilnacipran (1S, 2R-milnancipran) is an enantiomer of racemic milnacipran formulated as a once-daily, extended release therapy. Discovered by Pierre Fabre, the drug is licensed to Forest Laboratories for the U.S. and Canada.