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milnacipran 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	1808	92623-85-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: milnacipran midalcipran (+/-)-Milnacipran milnacipran hydrochloride milnacipran HCl	A cyclopropanecarboxamide serotonin and norepinephrine reuptake inhibitor (SNRI) that is used in the treatment of FIBROMYALGIA. Molecular weight: 246.35 Formula: C15H22N2O CLOGP: 1.91 LIPINSKI: 0 HAC: 3 HDO: 1 TPSA: 46.33 ALOGS: -2.30 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

milnacipran
midalcipran
(+/-)-Milnacipran
milnacipran hydrochloride
milnacipran HCl

A cyclopropanecarboxamide serotonin and norepinephrine reuptake inhibitor (SNRI) that is used in the treatment of FIBROMYALGIA.

Molecular weight: 246.35
Formula: C15H22N2O
CLOGP: 1.91
LIPINSKI: 0
HAC: 3
HDO: 1
TPSA: 46.33
ALOGS: -2.30
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.10	g	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	84 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	8.17 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	6.48 hours	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	55 %	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	4.51 L/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	11.60 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma)	0.87 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Jan. 14, 2009	FDA	CYPRESS BIOSCIENCE

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Suicidal ideation	136.71	17.75	86	7075	62335	63419526
Drug hypersensitivity	98.26	17.75	146	7015	310541	63171320
Serotonin syndrome	93.04	17.75	51	7110	28631	63453230
Somatic delusion	77.26	17.75	17	7144	575	63481286
Hyperhidrosis	72.05	17.75	74	7087	107762	63374099
Nausea	65.94	17.75	228	6933	854243	62627618
Migraine	60.29	17.75	66	7095	103280	63378581
Hot flush	55.38	17.75	46	7115	51113	63430748
Blepharospasm	55.32	17.75	22	7139	5974	63475887
Headache	50.42	17.75	171	6990	633070	62848791

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Urinary retention	48.56	26.18	23	1022	36265	34919621
Suicidal ideation	46.22	26.18	23	1022	40365	34915521
Agoraphobia	40.87	26.18	7	1038	245	34955641
Bicytopenia	34.66	26.18	9	1036	2375	34953511
Dysuria	32.62	26.18	16	1029	27136	34928750
Neurosis	29.69	26.18	5	1040	158	34955728
Urinary hesitation	28.59	26.18	8	1037	2794	34953092

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Suicidal ideation	129.32	18.90	78	6118	76262	79661930
Drug hypersensitivity	109.45	18.90	125	6071	298791	79439401
Somatic delusion	80.31	18.90	17	6179	701	79737491
Serotonin syndrome	68.51	18.90	43	6153	44984	79693208
Migraine	64.89	18.90	54	6142	87439	79650753
Blepharospasm	63.84	18.90	22	6174	5829	79732363
Headache	52.36	18.90	139	6057	653633	79084559
Gastrointestinal motility disorder	47.90	18.90	18	6178	6104	79732088
Persistent genital arousal disorder	45.22	18.90	9	6187	272	79737920
Urine odour abnormal	43.89	18.90	17	6179	6256	79731936

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N06AX17	NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Other antidepressants
FDA EPC	N0000175749	Serotonin and Norepinephrine Reuptake Inhibitor
FDA MoA	N0000000102	Norepinephrine Uptake Inhibitors
FDA MoA	N0000000109	Serotonin Uptake Inhibitors
MeSH PA	D000700	Analgesics
MeSH PA	D018712	Analgesics, Non-Narcotic
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D049990	Membrane Transport Modulators
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D014179	Neurotransmitter Uptake Inhibitors

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Fibromyalgia	indication	203082005	DOID:631
Tachyarrhythmia	contraindication	6285003
Urinary tract obstruction	contraindication	7163005	DOID:5200
Alcoholism	contraindication	7200002
Hypertensive disorder	contraindication	38341003	DOID:10763
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Syndrome of inappropriate vasopressin secretion	contraindication	55004003	DOID:3401
Acute nephropathy	contraindication	58574008
Blood coagulation disorder	contraindication	64779008	DOID:1247
Hyponatremia	contraindication	89627008

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.64	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG	SAVELLA	ABBVIE	N022256	Jan. 14, 2009	RX	TABLET	ORAL	6602911	Jan. 14, 2023	MANAGEMENT OF FIBROMYALGIA (FM)
100MG	SAVELLA	ABBVIE	N022256	Jan. 14, 2009	RX	TABLET	ORAL	7994220	Sept. 19, 2029	MANAGEMENT OF FIBROMYALGIA
12.5MG	SAVELLA	ABBVIE	N022256	Jan. 14, 2009	RX	TABLET	ORAL	6602911	Jan. 14, 2023	MANAGEMENT OF FIBROMYALGIA (FM)
12.5MG	SAVELLA	ABBVIE	N022256	Jan. 14, 2009	RX	TABLET	ORAL	7994220	Sept. 19, 2029	MANAGEMENT OF FIBROMYALGIA
25MG	SAVELLA	ABBVIE	N022256	Jan. 14, 2009	RX	TABLET	ORAL	6602911	Jan. 14, 2023	MANAGEMENT OF FIBROMYALGIA (FM)
25MG	SAVELLA	ABBVIE	N022256	Jan. 14, 2009	RX	TABLET	ORAL	7994220	Sept. 19, 2029	MANAGEMENT OF FIBROMYALGIA
50MG	SAVELLA	ABBVIE	N022256	Jan. 14, 2009	RX	TABLET	ORAL	6602911	Jan. 14, 2023	MANAGEMENT OF FIBROMYALGIA (FM)
50MG	SAVELLA	ABBVIE	N022256	Jan. 14, 2009	RX	TABLET	ORAL	7994220	Sept. 19, 2029	MANAGEMENT OF FIBROMYALGIA

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN	INHIBITOR	Ki	7.29	WOMBAT-PK	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN	INHIBITOR	Ki	7.60	WOMBAT-PK	CHEMBL
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		IC50	5.21	CHEMBL
Glutamate receptor ionotropic, NMDA 2A	Ion channel	Q12879	NMDE1_HUMAN		IC50	5.20	WOMBAT-PK
Sodium-dependent serotonin transporter	Transporter		SC6A4_RAT		IC50	7.33	CHEMBL
Sodium-dependent dopamine transporter	Transporter		SC6A3_RAT		IC50	4.43	CHEMBL
Transporter	Transporter		Q63380_RAT		IC50	7.52	CHEMBL

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External reference:

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ID	Source
008263	NDDF
008264	NDDF
101152-94-7	SECONDARY_CAS_RN
26139	MMSL
30003	RXNORM
4025253	VUID
4025253	VANDF
4028372	VANDF
441641002	SNOMEDCT_US
442542004	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Milnacipran HCl	HUMAN PRESCRIPTION DRUG LABEL	1	65162-091	TABLET	12.50 mg	ORAL	ANDA	21 sections
Milnacipran HCl	HUMAN PRESCRIPTION DRUG LABEL	1	65162-091	TABLET	12.50 mg	ORAL	ANDA	21 sections
Milnacipran HCl	HUMAN PRESCRIPTION DRUG LABEL	1	65162-091	TABLET	12.50 mg	ORAL	ANDA	21 sections
Milnacipran HCl	HUMAN PRESCRIPTION DRUG LABEL	1	65162-092	TABLET	25 mg	ORAL	ANDA	21 sections
Milnacipran HCl	HUMAN PRESCRIPTION DRUG LABEL	1	65162-092	TABLET	25 mg	ORAL	ANDA	21 sections
Milnacipran HCl	HUMAN PRESCRIPTION DRUG LABEL	1	65162-092	TABLET	25 mg	ORAL	ANDA	21 sections
Milnacipran HCl	HUMAN PRESCRIPTION DRUG LABEL	1	65162-093	TABLET	50 mg	ORAL	ANDA	21 sections
Milnacipran HCl	HUMAN PRESCRIPTION DRUG LABEL	1	65162-093	TABLET	50 mg	ORAL	ANDA	21 sections
Milnacipran HCl	HUMAN PRESCRIPTION DRUG LABEL	1	65162-093	TABLET	50 mg	ORAL	ANDA	21 sections
Milnacipran HCl	HUMAN PRESCRIPTION DRUG LABEL	1	65162-094	TABLET	100 mg	ORAL	ANDA	21 sections

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