Forest Laboratories and Pierre Fabre Laboratories have received FDA approval for Fetzima (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI), for the treatment of major depressive disorder (MDD) in adults.
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In placebo-controlled, pivotal Phase 3 studies of adult patients with major depressive disorder (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).
While structurally similar to the SNRI milnacipran (Savella; Forest), levomilnacipran is not approved for the management of fibromyalgia.
Fetzima will be available in the 4th quarter of 2013.
For more information call (800) 678-1605 or visit FRX.com.