The US Food and Drug Administration has approved levomilnacipran (Fetzima, Forest Laboratories, Inc.), a new serotonin-norepinephrine reuptake inhibitor (SNRI), for major depressive disorder (MDD) in adults, making the drug the fourth SNRI to be approved in the United States.
The drug is available as a once-daily sustained-release formulation. According to the manufacturer, Forest Laboratories, levomilnacipran has greater potency for norepinephrine reuptake inhibition than for serotonin reuptake inhibition in vitro without directly affecting the uptake of dopamine or other neurotransmitters. It has been developed as a sustained-release formulation dosed once daily.
"As many people with MDD struggle to find a treatment that works for them, Fetzima provides patients and physicians with an additional option for treating this serious disease," said Michael Liebowitz, MD, professor of clinical psychiatry at Columbia University, in New York City, in a joint statement from Pierre Fabre Laboratories, the company that discovered the agent, and Forest Laboratories, the codeveloper.
Recent phase 3 data from a pivotal trial presented at the European College of Neuropsychopharmacology and reported by Medscape Medical News at that time showed all 3 daily doses — 40 mg, 80 mg, or 120 mg — of the drug improved symptoms compared with placebo.
The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) in the placebo-controlled trials were nausea, constipation, hyperhidrosis, increased heart rate, erectile dysfunction, tachycardia, vomiting, and palpitations. Rates of adverse events were generally consistent across doses (40 to 120 mg); the only dose-related adverse events (greater than 2% overall incidence) were urinary hesitation and erectile dysfunction.