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Fetzima (levomilnacipran)

Company: Forest Laboratories
Approval Status: Approved July 2013
Treatment for: major depressive disorder
Areas: Neurology & Nervous System; Psychiatry / Psychiatric

| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |

General Information

Fetzima (levomilnacipran) is an extended release selective norepinephrine and serotonin reuptake inhibitor.

Fetzima is specifically indicated for the treatment of Major Depressive Disorder.

Fetzima is supplied as a capsule for oral administration. The recommended dose is 40 mg to 120 mg once daily with or without food. Initiate dose at 20 mg once daily for 2 days and then increase to 40 mg once daily. The dose should be increased in increments of 40 mg at intervals of 2 or more days. The maximum recommended dose is 120 mg once daily. The capsules should be swallowed whole.

Clinical Results

FDA Approval
The FDA approval of Fetzima was based on three 8-week randomized, double-blind, placebo-controlled studies (at doses 40­120 mg once daily) in adult (18 - 78 years of age) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD. Two of the studies were fixed dose (Study 1 and Study 2) and one study was flexible dose (Study 3). In Study 1, patients received 40 mg, 80 mg or 120 mg of Fetzima once daily, or placebo. In Study 2, patients received either 40 mg or 80 mg of Fetzima once daily, or placebo. In the flexible-dose study (Study 3), patients received 40 to 120 mg of Fetzima once daily, or placebo. In all three studies, Fetzima demonstrated superiority over placebo in the improvement of depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) total score. Fetzima also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale (SDS) functional impairment total score.

Side Effects

Adverse events associated with the use of Fetzima may include, but are not limited to, the following:

  • nausea
  • constipation
  • hyperhidrosis
  • heart rate increase
  • erectile dysfunction
  • tachycardia
  • vomiting
  • palpitations

Mechanism of Action

Fetzima (levomilnacipran) is an extended release selective norepinephrine and serotonin reuptake inhibitor. The exact mechanism of the antidepressant action of levomilnacipran is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of reuptake at serotonin and norepinephrine transporters. Non-clinical studies have shown that levomilnacipran is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI).

Literature References

Asnis GM, Bose A, Gommoll CP, Chen C, Greenberg WM 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. Journal of Clinical Psychiatry 2013 Mar;74(3):242-8

Montgomery SA, Mansuy L, Ruth A, Bose A, Li H, Li D Efficacy and safety of levomilnacipran sustained release in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled, proof-of-concept study. Journal of Clinical Psychiatry 2013 Apr;74(4):363-9

Additional Information

For additional information regarding Fetzima or major depressive disorder, please visit the Fetzima web page.

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Fetzima Drug Information

The Fetzima drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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