The U.S. Food and Drug Administration (FDA) has approved levomilnacipran (Fetzima) as a new drug. The New Drug Application (NDA) was submitted by Forest Laboratories, Inc. [1].
What is Levomilnacipran and What is it Used For?
Levomilnacipran is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) used for the treatment of major depressive disorder (MDD) in adults [1]. It works by increasing the levels of serotonin and norepinephrine in the brain, which are neurotransmitters that help regulate mood [2].
When Was Levomilnacipran Approved by the FDA?
Levomilnacipran received FDA approval on July 23, 2013 [1].
What is the Dosage Information for Levomilnacipran?
Levomilnacipran is available in capsule form with dosages including 20 mg, 40 mg, 80 mg, and 120 mg [3]. The recommended starting dose is 40 mg once daily, with the potential to increase to a maximum dose of 120 mg once daily [3].
What Are the Potential Side Effects of Levomilnacipran?
Common side effects associated with levomilnacipran include nausea, constipation, insomnia, hyperhidrosis, and erectile dysfunction [3]. A boxed warning is included regarding the increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults [3].
Are There Any Contraindications for Levomilnacipran?
Levomilnacipran is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI, as well as within 14 days of stopping levomilnacipran. It is also contraindicated in patients with uncontrolled narrow-angle glaucoma [3].
How Does Levomilnacipran Compare to Other Antidepressants?
As an SNRI, levomilnacipran targets both serotonin and norepinephrine, similar to other SNRIs like duloxetine and venlafaxine. However, it is the levo-enantiomer of milnacipran, which is approved for fibromyalgia [2]. Its specific efficacy and side effect profile may differ from other antidepressants.
Are There Any Patent Expirations for Levomilnacipran?
Information regarding patent expiry dates for levomilnacipran can be found on DrugPatentWatch.com [4].
Who Manufactures Levomilnacipran?
Forest Laboratories, Inc. (now part of AbbVie) was the original sponsor of the NDA for levomilnacipran [1].
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1. Forest Laboratories Inc. FDA New Drug Application approval for Fetzima (levomilnacipran) extended-release capsules. [Internet]. Available from: https://www.drugpatentwatch.com/press-releases/forest-laboratories-inc-fda-new-drug-application-approval-for-fetzima-levomilnacipran-extended-release-capsules
2. Levomilnacipran. [Internet]. Available from: https://www.drugpatentwatch.com/drug/levomilnacipran
3. Fetzima (levomilnacipran) prescribing information. [Internet]. Available from: https://www.drugpatentwatch.com/drug/levomilnacipran
4. DrugPatentWatch. [Internet]. Available from: https://www.drugpatentwatch.com/