FDA approves Fetzima (Forest/Pierre Fabre) for Depression

Forest Laboratories and Pierre Fabre Laboratories announced that Fetzima (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI), discovered by Pierre Fabre Laboratories and co-developed by Forest Laboratories, Inc. was approved by the FDA on 26 July 2013, for the treatment of Major Depressive Disorder (MDD) in adults.

In the placebo-controlled, pivotal Phase III studies of adult patients with MDD, statistically significant and clinically meaningful improvement in depressive symptoms (primary endpoint) was demonstrated across three Fetzima dosage strengths of 40, 80, and 120 mg once daily compared with placebo as measured by the Montgomery �sberg Depression Rating Scale (MADRS) total score (primary endpoint). Fetzima also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale (SDS) functional impairment total score (secondary endpoint).