MedPath

Milnacipran

Generic Name
Milnacipran
Brand Names
Savella
Drug Type
Small Molecule
Chemical Formula
C15H22N2O
CAS Number
92623-85-3
Unique Ingredient Identifier
G56VK1HF36

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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