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Forest Submits NDA for Levomilnacipran for Major Depressive Disorder
Forest Laboratories, Inc., based in New York, N.Y., announced on September 27 that it has submitted a new drug application (NDA) to the FDA for levomilnacipran, a serotonin–norepinephrine reuptake inhibitor (SNRI) for the treatment of major depressive disorder (MDD) in adults.
The company’s application includes results from three phase III trials — two double-blind, fixed-dose studies and one flexible-dose study — that evaluated the efficacy of levomilnacipran compared with placebo in adults with MDD. More than 1,600 adult patients received a once-daily dose of either levomilnacipran (40, 80, or 120 mg) or placebo in the three studies.
In each of the trials, statistically significant improvement was seen for the levomilnacipran groups compared with the placebo group in the primary and secondary endpoints (the change from baseline in the Montgomery-Åsberg Depression Rating Scale total score and in the Sheehan Disability Scale total score, respectively).
In addition, safety data collected from the phase III program demonstrated that levomilnacipran 40, 80, or 120 mg once daily was generally well tolerated. Nausea was the most common adverse reaction.
An SNRI, 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. The drug has been developed as a sustained-release formulation, dosed once daily.
MDD affects more than 15 million adults in the U.S. annually, or approximately 7.3% of the adult U.S. population. People diagnosed with MDD may have a combination of symptoms that interfere with their ability to work, sleep, study, eat, or enjoy once-pleasurable activities. Depression costs the U.S. an estimated $44 billion each year.
Among all medical illnesses, MDD is a leading cause of disability in the U.S. The World Health Organization (WHO) predicts that depression will become the second leading cause of disability by the year 2020.
For more information, visit the Forest Laboratories Web site.