Forest Labs and Fabre's MMD drug gains FDA approval

US drugmaker Forest Laboratories (NYSE: FRX) and France-based independent Pierre Fabre Laboratories have gained US Food and Drug Administration for their co-developed Fetzima (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI), for the treatment of major depressive disorder (MDD) in adults.

The drug was discover by Fabre and licensed out to Forest for the USA and Canada. Forest, which is looking to replace lost sales of MMD drug Lexapro (escitalopram oxalate) due to patent expiry in March 2012, expects Fetzima to be available to wholesalers in the fourth calendar quarter of 2013.

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 40mg, 80mg, and 120mg once daily compared with placebo as measured by the Montgomery Åsberg 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).