Levomilnacipran Extended Release: First Global Approval

  title={Levomilnacipran Extended Release: First Global Approval},
  author={Philip I. Hair and Fiona Cameron and Karly P Garnock-jones},
Pierre Fabre and Forest Laboratories are developing levomilnacipran extended release (ER) [FETZIMA™], an enantiomer of milnacipran, for the treatment of major depressive disorder (MDD). In addition, Pierre Fabre (the originator of the compound) is developing the drug to improve recovery in patients with ischaemic stroke. Levomilnacipran ER exerts its effects by selectively inhibiting the reuptake of norepinephrine and serotonin (two neurotransmitters known to play an essential role in… 

The Role of Levomilnacipran in the Management of Major Depressive Disorder: A Comprehensive Review

Preliminary evidence suggests that levomilnacipran ER may be effective in improving not only depressive symptoms but also symptoms related to functioning (social life, work, and family life) in relation to currently available antidepressants including other SNRIs.

Novel drugs in depression - A new hope

Agomelatine, vortioxetine, vilazodone, and levomilnacipran extended release (ER) having different mechanisms have been recently approved by the United States Food and Drug Administration.



Levomilnacipran ER 40 mg and 80 mg in patients with major depressive disorder: a phase III, randomized, double-blind, fixed-dose, placebo-controlled study.

Levomilnacipran ER at doses of 40 mg/ day and 80 mg/day demonstrated efficacy on symptomatic and functional measures of MDD and was generally well tolerated in this patient population.

Efficacy and safety of levomilnacipran sustained release in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled, proof-of-concept study.

Levomilnacipran SR demonstrated robust efficacy on all measures and was generally well tolerated in major depressive disorder and in outpatients meeting DSM-IV criteria for a major depressive episode.

A Phase III, Double-Blind, Placebo-Controlled, Flexible-Dose Study of Levomilnacipran Extended-Release in Patients With Major Depressive Disorder

There was a statistically significant difference in the score change from baseline to week 8 between levomilnacipran ER and placebo on several depression rating scales, reflecting symptomatic and functional improvement; treatment was generally well tolerated.

Efficacy and safety of levomilnacipran sustained release 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase 3, randomized, double-blind, placebo-controlled study.

Levomilnacipran SR demonstrated significant improvement in depressive symptoms and functioning relative to placebo in patients with major depressive disorder and was generally well tolerated.

The Epidemiological Modelling of Major Depressive Disorder: Application for the Global Burden of Disease Study 2010

The modelled epidemiological profile of MDD was presented dealing with heterogeneity in the data, enforcing internal consistency between epidemiological parameters and making estimates for world regions with no empirical data, which informed GBD 2010 and the public health field, with a clearer understanding of the global distribution ofMDD.

Levomilnacipran SR 40 mg and 80 mg in major depressive disorder: a phase III, randomized, double-blind, fixed-dose, placebo-controlled study

  • [abstract no. W190]. Neuropsychopharmacology
  • 2012

Letter of New Drug Application approval for levomilnacipran extended-release capsules [NDA 204168

  • http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/ 204168Orig1s000ltr.pdf. Accessed
  • 2013