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FDA Approves Extended-Release Levomilnacipran (Fetzima) for Treatment of Major Depressive Disorder

Depression and disability scales significantly improved versus placebo (July 26)

The FDA has give the green light to levomilnacipran extended-release capsules (Fetzima, Forest Laboratories/ Pierre Fabre Laboratories), a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI), for the treatment of major depressive disorder (MDD) in adults.

The efficacy of extended-release levomilnacipran versus placebo was demonstrated in three pivotal, double-blind phase III trials. More than 1,600 adults with MDD received a once-daily dose of either levomilnacipran (40, 80, or 120 mg) or placebo in the three trials. In each study, the primary endpoint was the change from baseline to endpoint in the Montgomery–├ůsberg Depression Rating Scale (MADRS) total score, and the secondary endpoint was the change from baseline to endpoint in the Sheehan Disability Scale (SDS) total score.

In all three studies, statistically significant improvements were observed in the levomilnacipran groups compared with the placebo groups on both the primary and secondary endpoints.

The most common adverse reactions were nausea, constipation, hyperhidrosis, increased heart rate, erectile dysfunction, tachycardia, vomiting, and palpitations. Rates of adverse events were generally consistent across doses (40–120 mg); the only dose-related adverse events were urinary hesitation and erectile dysfunction.

MDD affects approximately 16 million adults in the U.S. every year. The World Health Organization (WHO) predicts that depression will become the second leading cause of disability by the year 2020.

Source: Forest Laboratories; July 26, 2013.

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