Overview
Milnacipran is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) and like many agents in this category was originally developed for and continues to be approved and indicated for the treatment of depression . Furthermore, in 2009 the US FDA approved milnacipran for the additional indication of treating fibromyalgia , although other regional regulatory authorities like the EMA, among others, have not yet approved the agent for such treatment, citing lack of robust evidence of efficacy, insufficient demonstration of maintenance of effect, and other concerns . Nevertheless, milnacipran demonstrates a somewhat unique characteristic among SNRIs to elicit a relatively balanced reuptake inhibition of both serotonin and noradrenaline, with a somewhat increased preference for noradrenaline reuptake inhibition - which is potentially a point of interest given the plausible proposal that noradrenaline plays an important role in the mitigation of pain signals in the descending inhibitory pain pathways in the brain and spinal cord . Moreover, recent research has shown that the levorotatory enantiomer of milnacipran, levomilnacipran, may have the capacity to inhibit the activity of beta-site amyloid precursor protein cleaving enzyme-1 (BACE-1), which has investigationally been associated with β-amyloid plaque formation - making the agent a possible course of treatment for Alzheimer's disease .
Indication
Milnacipran is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia in patients that are 18 years old or above . While milnacipran may be used for the treatment of major depressive disorder (MDD), it is only recommended in adult patients who are 18 years old or above due to an increased risk for suicidal ideation, thinking, and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Some regional prescribing information notes that the use of the medication is specifically for the short-term symptomatic relief of MDD . Nevertheless, it is important to note that the regulatory approval of and/or indications listed here for milnacipran may or may not exist and/or vary greatly between regions and nations .
Associated Conditions
- Fibromyalgia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/05/20 | Not Applicable | UNKNOWN | |||
2016/05/26 | Phase 2 | Recruiting | University Hospital, Lille | ||
2016/02/22 | Not Applicable | Terminated | |||
2013/08/01 | Phase 2 | UNKNOWN | |||
2013/04/11 | Phase 3 | Completed | |||
2013/01/29 | Phase 4 | Completed | |||
2012/12/11 | Phase 2 | UNKNOWN | University Hospital, Clermont-Ferrand | ||
2012/01/16 | Phase 4 | Completed | Dr. Norman Harden | ||
2011/11/16 | Phase 2 | Terminated | Spencer Dorn, MD, MPH | ||
2011/08/17 | Phase 3 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 35356-545 | ORAL | 50 mg in 1 1 | 12/20/2018 | |
Allergan, Inc. | 0456-1525 | ORAL | 25 mg in 1 1 | 2/6/2024 | |
Amneal Pharmaceuticals LLC | 65162-094 | ORAL | 100 mg in 1 1 | 3/22/2023 | |
Allergan, Inc. | 0456-1512 | ORAL | 12.5 mg in 1 1 | 2/6/2024 | |
Amneal Pharmaceuticals LLC | 65162-093 | ORAL | 50 mg in 1 1 | 3/22/2023 | |
Cardinal Health 107, LLC | 55154-4626 | ORAL | 50 mg in 1 1 | 12/30/2018 | |
Amneal Pharmaceuticals LLC | 65162-091 | ORAL | 12.5 mg in 1 1 | 3/22/2023 | |
Allergan, Inc. | 0456-1550 | ORAL | 50 mg in 1 1 | 2/6/2024 | |
Physicians Total Care, Inc. | 54868-6043 | ORAL | 50 mg in 1 1 | 12/9/2011 | |
Amneal Pharmaceuticals LLC | 65162-092 | ORAL | 25 mg in 1 1 | 3/22/2023 |
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. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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