Registration dossier for our levomilnacipran submitted in the united statesfor the treatment of major depressive disorders

September 28, 2012

Forest Laboratories and Pierre Fabre Médicament have submitted a registration dossier to the US health authorities (Food and Drug Administration) for levomilnacipran, a serotonin-norepinephrine reuptake inhibitor (SNRI) used to treat major depressive disorders in adults.

Levomilnacipran, a molecule from Pierre Fabre research, was developed jointly by Forest and Pierre Fabre for the treatment of major depressive disorders in adults. It was approved in 2008 by Forest Laboratories for sale in the United Statesand Canada, with Pierre Fabre providing the active substance.

The registration dossier is based on positive results obtained during three randomized, double-blind, placebo-controlled Phase III studies (two of which were fixed-dose studies, and one a flexible-dose study), evaluating the efficacy of levomilnacipran versus placebo in adult patients with major depressive disorders.

In these three studies, more than 1,600 patients received a daily dose of 40 to 120 mg levomilnacipran or placebo. In each of these studies, statistically significant results were obtained versus placebo, according to the MADRS‐CR (Montgomery‐Åsberg Depression Rating Scale ‐Clinician Rated) and SDS (Sheehan Disability Scale).
Furthermore, daily doses of 40 to 120 mg levomilnacipran were generally well tolerated, with a similar incidence of adverse effects in each treatment group. The most common adverse effect in the levomilnacipran groups was nausea (≥ 10%, twice as common as with placebo).

Information about levomilnacipran
Levomilnacipran (1S, 2R‐milnacipran), an enantiomer of racemic milnacipran, is protected by a patent covering its use until June 2023. As an SNRI, levomilnacipran has a greater in vitro recapture inhibition potential for norepinephrine than for serotonin, but this does not affect recapture of dopamine or other neurotransmitters. Levomilnacipran is available in prolonged-release form, administered once daily.

Information about major depressive disorders
Major depressive disorders are serious conditions requiring appropriate treatment that affect more than 15 million adults per year in the United States, i.e. more than 7.3% of American adults. Those suffering from major depressive disorders may have a combination of symptoms that interfere with their ability to work, sleep, study, eat and enjoy pleasurable activities. In the United States,the annual cost of depression is roughly 44 million USD. Of all diseases, major depressive disorders are among the main causes of invalidity in the United States. According to the World Health Organization, depression may become the second largest cause of incapacity by 2020.