Out Of The Pipeline

Levomilnacipran for the treatment of major depressive disorder

Current Psychiatry. 2013 December;12(12):50-52, 54-55

References

1. Fetzima [package insert]. St. Louis, MO: Forest Laboratories; 2013.

2. Auclair AL, Martel JC, Assié MB, et al. Levomilnacipran (F2695), a norepinephrine-preferring SNRI: profile in vitro and in models of depression and anxiety. Neuropharmacology. 2013;70:338-347.

3. Montgomery SA, Mansuy L, Ruth A, et al. Efficacy and Safety of levomilnacipran sustained release in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled, proof-of-concept study. J Clin Psychiatry. 2013;74(4):363-369.

4. Kasper S, Meshkat D, Kutzelnigg A. Improvement of the noradrenergic symptom cluster following treatment with milnacipran. Neuropsychiatric Dis Treat. 2011; 7(suppl 1):21-27.

5. Asnis GM, Bose A, Gommoll CP, et al. 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. J Clin Psychiatry. 2013;74(3):242-248.

6. Hutt AJ, Vanetová J. The chiral switch: the development of single enantiomer drugs from racemates. Acta Facultatis Pharmaceuticae Universitatis Comenianae. 2003; 50(7):23.

7. U.S. Food and Drug Administration. Development of new stereoisomeric drugs. Published May 1, 1992. http://www.fda.gov/drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122883.htm#.UKHEWm4ZyYE.email. Accessed October 8, 2013.

Dosing

The recommended dosage range of levomilnacipran is 40 to 120 mg once
daily with or without food. The capsules should be swallowed whole and should not be opened or crushed. As with most psychotropics, levomilnacipran should be taken at approximately the same time each day.¹

The manufacturer recommends an initial dose of levomilnacipran of 20 mg once daily for 2 days, increased to 40 mg once daily. Based on efficacy and tolerably, levomilnacipran can be increased in increments of 40 mg every 2 days.

Dosage adjustment is recommended for patients with moderate or severe renal impairment; and the maintenance dosage should not exceed 80 mg and 40 mg respectively in these populations. As with many antidepressants, gradual dosage reduction is recommended to avoid discontinuation symptoms.

Bottom Line

Levomilnacipran is FDA-approved for treating major depressive disorder in adults. In 2 randomized controlled trials, the drug showed a significant separation from placebo. Levomilnacipran generally was reported to be safe and well tolerated; common adverse events were nausea, vomiting, changes in blood pressure, and an increase in heart rate.

Related Resources

Citrome L. Levomilnacipran for major depressive disorder: a systematic review of the efficacy and safety profile for this newly approved antidepressant - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? [published online September 8, 2013]. Int J Clin Pract. doi: 10.1111/ijcp.12298.
Mago R, Forero G, Greenberg WM, et al. Safety and tolerability of levomilnacipran ER in major depressive disorder: results from an open-label, 48-week extension study. Clin Drug Investig. 2013;33(10):761-771.

Drug Brand Names
Duloxetine • Cymbalta Milnacipran • Savella
Ketoconazole • Nizoral Venlafaxine • Effexor Levomilnacipran • Fetzima

Disclosures

Dr. Macaluso has been the principal investigator for clinical trials for AbbVie, Eisai, Envivo, Janssen, Naurex, and Pfizer. All clinical trial and study contracts and payments were made through the Kansas University Medical Center Research Institute. Drs. Kazanchi and Malhotra report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

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Levomilnacipran for the treatment of major depressive disorder

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