Tapentadol
Nucynta (tapentadol) is a small molecule pharmaceutical. Tapentadol was first approved as Nucynta on 2008-11-20. It is used to treat pain in the USA. The pharmaceutical is active against mu-type opioid receptor and sodium-dependent noradrenaline transporter.
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Commercial
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Nucynta
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tapentadol hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NUCYNTA | Collegium Pharmaceutical | N-022304 RX | 2008-11-20 | 3 products, RLD, RS |
| NUCYNTA ER | Collegium Pharmaceutical | N-200533 RX | 2011-08-25 | 5 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nucynta | New Drug Application | 2023-12-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pain | EFO_0003843 | D010146 | R52 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TAPENTADOL HYDROCHLORIDE, NUCYNTA, COLLEGIUM PHARM INC | |||
| 2026-07-03 | NPP | ||
HCPCS
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Clinical
Clinical Trials
78 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | 1 | 6 | 15 | 1 | 1 | 23 |
| Chronic pain | D059350 | HP_0012532 | — | — | 3 | 9 | 1 | 2 | 15 |
| Back pain | D001416 | HP_0003418 | M54 | — | 2 | 9 | 3 | — | 14 |
| Low back pain | D017116 | HP_0003419 | M54.5 | — | 2 | 8 | 3 | — | 13 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 2 | 9 | 1 | — | 12 |
| Postoperative pain | D010149 | — | G89.18 | — | 4 | 3 | 3 | 1 | 11 |
| Acute pain | D059787 | — | R52 | — | 1 | 8 | 1 | 1 | 11 |
| Neuralgia | D009437 | EFO_0009430 | — | — | 1 | 1 | 3 | 2 | 7 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 2 | 3 | 1 | — | 6 |
| Peripheral nervous system diseases | D010523 | HP_0009830 | G64 | — | — | 3 | 1 | — | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | 1 | 5 | — | 1 | 7 |
| Cancer pain | D000072716 | — | G89.3 | — | 1 | 4 | — | 2 | 7 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | 1 | 3 | — | — | 4 |
| Arthralgia | D018771 | HP_0002829 | M25.5 | — | — | 4 | — | — | 4 |
| Hallux valgus | D006215 | HP_0001822 | — | — | — | 4 | — | — | 4 |
| Bunion | D000071378 | — | M21.61 | — | 1 | 3 | — | — | 4 |
| Joint diseases | D007592 | HP_0003040 | M12.9 | — | — | 2 | — | — | 2 |
| Pain measurement | D010147 | — | — | — | — | 2 | — | — | 2 |
| Nociceptive pain | D059226 | — | — | — | — | 1 | — | — | 1 |
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postherpetic neuralgia | D051474 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | — | — | — | — | 7 |
| Pharmacokinetics | D010599 | — | — | 4 | — | — | — | — | 4 |
| Hyperalgesia | D006930 | — | — | 1 | — | — | — | — | 1 |
| Disease | D004194 | EFO_0000408 | R69 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | — | 2 | 2 |
| Analgesia | D000698 | — | — | — | — | — | — | 2 | 2 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | — | — | — | 1 | 1 |
| Narcotic-related disorders | D000079524 | — | — | — | — | — | — | 1 | 1 |
| Immunity | D007109 | — | — | — | — | — | — | 1 | 1 |
| Substance abuse detection | D015813 | — | — | — | — | — | — | 1 | 1 |
| Procedural pain | D000073818 | — | — | — | — | — | — | 1 | 1 |
| Walker-warburg syndrome | D058494 | Orphanet_899 | Q04.3 | — | — | — | — | 1 | 1 |
| Syndrome | D013577 | — | — | — | — | — | — | 1 | 1 |
| Agnosia | D000377 | HP_0030222 | F88 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tapentadol |
| INN | tapentadol |
| Description | Tapentadol is an alkylbenzene. |
| Classification | Small molecule |
| Drug class | analgesics (mixed opiate receptor agonists/antagonists) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@@H](c1cccc(O)c1)[C@@H](C)CN(C)C |
Identifiers
| PDB | — |
| CAS-ID | 175591-09-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201776 |
| ChEBI ID | — |
| PubChem CID | 9838022 |
| DrugBank | DB06204 |
| UNII ID | H8A007M585 (ChemIDplus, GSRS) |
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Nucynta – Assertio Therapeutics
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Nucynta – Assertio Therapeutics
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Nucynta – Collegium Pharmaceutical
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Estimated US medical usage
Tapentadol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
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Additional graphs summarizing 2,398 documents
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Safety
Black-box Warning
Black-box warning for: Nucynta
Adverse Events
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30,410 adverse events reported
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