Stem definition | Drug id | CAS RN |
---|---|---|
4468 | 33643-46-8 |
Dose | Unit | Route |
---|---|---|
8 | mg | N |
None
Date | Agency | Company | Orphan |
---|---|---|---|
Dec. 18, 2019 | EMA | Janssen-Cilag International N.V. | |
May 3, 2019 | FDA | JANSSEN PHARMS |
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 |
---|---|---|---|---|---|---|
Dissociation | 1119.73 | 39.60 | 170 | 1821 | 2121 | 50601012 |
Sedation | 327.83 | 39.60 | 96 | 1895 | 30514 | 50572619 |
Suicidal ideation | 275.67 | 39.60 | 97 | 1894 | 55288 | 50547845 |
Suicide attempt | 112.69 | 39.60 | 50 | 1941 | 51682 | 50551451 |
Anxiety | 85.56 | 39.60 | 64 | 1927 | 177542 | 50425591 |
Dissociative disorder | 67.41 | 39.60 | 11 | 1980 | 214 | 50602919 |
Blood pressure increased | 46.86 | 39.60 | 40 | 1951 | 133092 | 50470041 |
Device malfunction | 40.66 | 39.60 | 17 | 1974 | 15104 | 50588029 |
Panic attack | 39.78 | 39.60 | 18 | 1973 | 19324 | 50583809 |
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 |
---|---|---|---|---|---|---|
Dissociation | 438.47 | 63.89 | 66 | 796 | 1063 | 29572602 |
Suicidal ideation | 163.45 | 63.89 | 54 | 808 | 34662 | 29539003 |
Sedation | 158.52 | 63.89 | 45 | 817 | 17360 | 29556305 |
Drug ineffective | 82.91 | 63.89 | 74 | 788 | 363096 | 29210569 |
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 |
---|---|---|---|---|---|---|
Dissociation | 1108.90 | 45.73 | 170 | 1885 | 2841 | 64493836 |
Sedation | 416.79 | 45.73 | 118 | 1937 | 41344 | 64455333 |
Suicidal ideation | 321.41 | 45.73 | 108 | 1947 | 66434 | 64430243 |
Suicide attempt | 146.41 | 45.73 | 62 | 1993 | 70945 | 64425732 |
Anxiety | 90.07 | 45.73 | 64 | 1991 | 202585 | 64294092 |
Dissociative disorder | 76.45 | 45.73 | 13 | 2042 | 408 | 64496269 |
Blood pressure increased | 59.77 | 45.73 | 47 | 2008 | 172505 | 64324172 |
Drug ineffective | 49.40 | 45.73 | 92 | 1963 | 840155 | 63656522 |
Device malfunction | 48.54 | 45.73 | 19 | 2036 | 17614 | 64479063 |
Dizziness | 47.40 | 45.73 | 63 | 1992 | 430100 | 64066577 |
None
Source | Code | Description |
---|---|---|
ATC | N01AX14 | NERVOUS SYSTEM ANESTHETICS ANESTHETICS, GENERAL Other general anesthetics |
ATC | N06AX27 | NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Other antidepressants |
MeSH PA | D000928 | Antidepressive Agents |
MeSH PA | D002491 | Central Nervous System Agents |
MeSH PA | D011619 | Psychotropic Drugs |
CHEBI has role | CHEBI:38877 | intravenous anesthetics |
CHEBI has role | CHEBI:60643 | N-methyl-D-aspartate receptor antagonists |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Depressive disorder | indication | 35489007 | |
Arteriovenous malformation | contraindication | 24551003 | |
Aneurysm | contraindication | 432119003 | DOID:178 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 7.65 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
EQ 28MG BASE | SPRAVATO | JANSSEN PHARMS | N211243 | March 5, 2019 | RX | SPRAY | NASAL | 9592207 | March 20, 2027 | TREATMENT OF TREATMENT-RESISTANT DEPRESSION IN ADULT IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT |
EQ 28MG BASE | SPRAVATO | JANSSEN PHARMS | N211243 | March 5, 2019 | RX | SPRAY | NASAL | 8785500 | March 5, 2033 | TREATMENT OF TREATMENT-RESISTANT DEPRESSION IN ADULT IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT |
EQ 28MG BASE | SPRAVATO | JANSSEN PHARMS | N211243 | March 5, 2019 | RX | SPRAY | NASAL | 10869844 | Sept. 10, 2035 | TREATMENT OF DEPRESSIVE SYMPTOMS IN ADULTS WITH MDD WITH ACUTE SUICIDAL IDEATION OR BEHAVIOR BY NASALLY ADMINISTERING 56MG OR 84 MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT |
EQ 28MG BASE | SPRAVATO | JANSSEN PHARMS | N211243 | March 5, 2019 | RX | SPRAY | NASAL | 10869844 | Sept. 10, 2035 | TREATMENT OF TRD IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE FOLLOWED BY A MAINTENANCE PHASE OF 56MG OR 84 MG WEEKLY OR 1X EVERY TWO WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT |
EQ 28MG BASE | SPRAVATO | JANSSEN PHARMS | N211243 | March 5, 2019 | RX | SPRAY | NASAL | 10869844 | Sept. 10, 2035 | TREATMENT OF TRD IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE IN CONJUNCTION WITH AN ORAL ANTIDEPRESSENT |
EQ 28MG BASE | SPRAVATO | JANSSEN PHARMS | N211243 | March 5, 2019 | RX | SPRAY | NASAL | 11311500 | Sept. 10, 2035 | TREATMENT OF DEPRESSIVE SYMPTOMS IN ADULTS WITH MDD WITH ACUTE SUICIDAL IDEATION OR BEHAVIOR BY NASALLY ADMINISTERING 56MG OR 84 MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT |
EQ 28MG BASE | SPRAVATO | JANSSEN PHARMS | N211243 | March 5, 2019 | RX | SPRAY | NASAL | 11311500 | Sept. 10, 2035 | TREATMENT OF TRD IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE FOLLOWED BY A MAINTENANCE PHASE OF 56MG OR 84 MG WEEKLY OR 1X EVERY TWO WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT |
EQ 28MG BASE | SPRAVATO | JANSSEN PHARMS | N211243 | March 5, 2019 | RX | SPRAY | NASAL | 11311500 | Sept. 10, 2035 | TREATMENT OF TRD IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE IN CONJUNCTION WITH AN ORAL ANTIDEPRESSENT |
EQ 28MG BASE | SPRAVATO | JANSSEN PHARMS | N211243 | March 5, 2019 | RX | SPRAY | NASAL | 11173134 | Sept. 14, 2035 | TREATMENT OF TRD IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE IN A MAINTENANCE PHASE WEEKLY OR 1X EVERY TWO WEEKS TO ADULTS WHO HAVE BEEN ADMINISTERED ESKETAMINE IN A INDUCTION PHASE FOR ABOUT 4 WEEKS |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
EQ 28MG BASE | SPRAVATO | JANSSEN PHARMS | N211243 | March 5, 2019 | RX | SPRAY | NASAL | July 31, 2023 | TREATMENT OF SYMPTOMS IN ADULTS WITH MAJOR DEPRESSIVE DISORDER (MDD) WITH ACUTE SUICIDAL IDEATION OR BEHAVIOR. |
EQ 28MG BASE | SPRAVATO | JANSSEN PHARMS | N211243 | March 5, 2019 | RX | SPRAY | NASAL | March 5, 2024 | NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT). |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Glutamate NMDA receptor | Ion channel | ANTAGONIST | Ki | 6.16 | SCIENTIFIC LITERATURE |
ID | Source |
---|---|
D07283 | KEGG_DRUG |
33643-47-9 | SECONDARY_CAS_RN |
4038229 | VANDF |
4038230 | VANDF |
CHEBI:60799 | CHEBI |
CHEMBL395091 | ChEMBL_ID |
CHEMBL2364609 | ChEMBL_ID |
DB11823 | DRUGBANK_ID |
C000629870 | MESH_SUPPLEMENTAL_RECORD_UI |
9152 | IUPHAR_LIGAND_ID |
7884 | INN_ID |
50LFG02TXD | UNII |
182137 | PUBCHEM_CID |
2119365 | RXNORM |
309966 | MMSL |
36280 | MMSL |
d09174 | MMSL |
015448 | NDDF |
015449 | NDDF |
785816006 | SNOMEDCT_US |
789486001 | SNOMEDCT_US |
C2825616 | UMLSCUI |
JC9 | PDB_CHEM_ID |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Spravato | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49396-0280 | SPRAY | 28 mg | NASAL | Export only | 1 sections |
Spravato | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-028 | SOLUTION | 28 mg | NASAL | NDA | 38 sections |