Levomilnacipran

Overview

Levomilnacipran is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), although it is a more potent inhibitor of norepinephrine reuptake than serotonin reuptake. Levomilnacipran is the more active 1S,2R-enantiomer in the racemate milnacipran. Once administered, interconversion between levomilnacipran and its stereoisomer does not occur in humans. First approved by the FDA on July 25, 2013, levomilnacipran is used to treat major depressive disorder in adults. While levomilnacipran was previously investigated and proposed as a potential treatment for stroke in Europe, the EMA decided against this use.

Background

Indication

Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) in adults.

Associated Conditions

Major Depressive Disorder (MDD)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder	2018/06/26	NCT03569475	Phase 3	Completed	Allergan
Levomilnacipran in Healthy Males	2017/08/15	NCT03249311	Phase 4	UNKNOWN	University of Ottawa
Neural Mechanisms of Monoaminergic Engagement in Late-life Depression Treatment Response (NEMO)	2017/04/25	NCT03128021	Phase 4	Completed	Howard Aizenstein
Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD	2016/03/25	NCT02720198	Phase 3	Completed	Duke University
Trial of Levomilnacipran in Geriatric Depression	2015/06/09	NCT02466958	Phase 4	Completed	University of California, Los Angeles
Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder	2015/05/01	NCT02431806	Phase 3	Completed	Forest Laboratories
A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder	2014/11/11	NCT02288325	Phase 4	Completed	Forest Laboratories
Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging	2014/10/17	NCT02266966	Phase 1	Completed	Pierre Fabre Medicament
Novel Medication as a Potential Smoking Cessation Aid	2014/10/15	NCT02265367	Not Applicable	Completed	University of Minnesota
Effect of F2695 on Functional Recovery After Ischemic Stroke	2012/07/12	NCT01639014	Phase 3	Completed	Pierre Fabre Medicament

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Fetzima	Allergan, Inc.	0456-2212	ORAL	120 mg in 1 1	10/10/2023
Levomilnacipran	Amneal Pharmaceuticals LLC	65162-960	ORAL	40 mg in 1 1	12/13/2023
Fetzima	Allergan, Inc.	0456-2240	ORAL	40 mg in 1 1	10/10/2023
Levomilnacipran	Amneal Pharmaceuticals LLC	65162-437	ORAL	80 mg in 1 1	12/13/2023
Fetzima	Allergan, Inc.	0456-2220	ORAL	20 mg in 1 1	10/10/2023
Fetzima	Allergan, Inc.	0456-2280	ORAL	80 mg in 1 1	10/10/2023
Levomilnacipran	Amneal Pharmaceuticals LLC	65162-411	ORAL	20 mg in 1 1	12/13/2023
Levomilnacipran	Amneal Pharmaceuticals LLC	65162-455	ORAL	120 mg in 1 1	12/13/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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