Forest Laboratories has submitted a New Drug Application in the USA for levomilnacipran, a serotonin norepinephrine reuptake inhibitor for the treatment of major depressive disorder (MDD) in adults.
The drug was discovered by France's Pierre Fabre and has been jointly developed by the two companies. The submission includes results from three positive Phase III studies involving more than 1,600 patients received a once-daily dose of either levomilnacipran (40, 80, 120mg) or placebo.
Forest notes that in each of the three studies, statistically significant improvement was seen for the levomilnacipran group compared with placebo , adding that the drug was generally well tolerated. The most commonly reported adverse reaction was nausea.
Forest is hoping that levomilnacipran will help fill the void in its coffers caused by the loss of patent protection on its flagship product Lexapro (escitalopram), an antidepressant licensed from Denmark’s Lundbeck.