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FDA approves Fetzima for depression treatment

The FDA has approved levomilnacipran, a once-daily serotonin and norepinephrine reuptake inhibitor, for the treatment of major depressive disorder, according to a press release from the company marketing the drug.

Levomilnacipran (Fetzima, Forest Laboratories) was discovered by French drugmaker Pierre Fabre Laboratories and co-developed by Forest Laboratories Inc.

"Because people respond differently to different medications, Forest Laboratories is dedicated to bringing a range of treatment possibilities to adults living with [major depressive disorder], as part of our growing mental health portfolio," Howard Solomon, chairman, CEO and president of Forest Laboratories, said in a press release. "The approval of Fetzima fulfills that commitment to the millions of people living with [major depressive disorder]."

Placebo-controlled phase 3 clinical studies demonstrated statistically significant improvements in depressive symptoms for all three dosages of levomilnacipran (40 mg, 80 mg and 120 mg), as measured by the Montgomery-Asberg Depression Rating Scale.

Common adverse events, which generally occurred at consistent rates across all dosages and at least twice the rate of placebo, included nausea, constipation, hyperhidrosis, increased heart rate, erectile dysfunction, tachycardia, vomiting and palpitations.