Overview
An opioid analgesic with actions and uses similar to those of morphine, apart from an absence of cough suppressant activity. It is used in the treatment of moderate to severe pain, including pain in obstetrics. It may also be used as an adjunct to anesthesia (From Martindale, The Extra Pharmacopoeia, 30th ed, p1092). On June 8, 2017, FDA requested Endo Pharmaceuticals to remove the medication from the market due to opioid misuse and abuse risks associated with the product's injectable reformulation.
Indication
For the treatment of moderate-to-severe pain.
Associated Conditions
- Anxiety
- Severe Pain
- Moderate Pain
Research Report
A Comprehensive Pharmacological and Clinical Monograph on Oxymorphone (DB01192)
Executive Summary
Oxymorphone is a potent, semi-synthetic morphinane alkaloid and opioid analgesic first developed in Germany in 1914.[1] As a small molecule drug, it exerts its primary therapeutic and adverse effects through potent agonist activity at the µ-opioid receptor, making it an effective agent for the management of moderate-to-severe pain.[3] Clinically, it has been available in immediate-release (IR) formulations for acute pain and extended-release (ER) formulations for chronic pain requiring around-the-clock therapy.[5]
Its pharmacokinetic profile is distinguished by two key features: a very low oral bioavailability of approximately 10% due to extensive first-pass metabolism, and a metabolic pathway that proceeds primarily through glucuronidation, notably independent of the cytochrome P450 (CYP) enzyme system.[3] This latter characteristic theoretically positions it as a favorable option in patients on complex medication regimens to avoid CYP-mediated drug-drug interactions.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/12/23 | Phase 3 | Suspended | Endo Pharmaceuticals | ||
2018/07/06 | Early Phase 1 | Terminated | |||
2016/02/22 | Phase 3 | Terminated | Endo Pharmaceuticals | ||
2015/12/09 | Not Applicable | Completed | |||
2010/09/28 | Phase 3 | Completed | Endo Pharmaceuticals | ||
2010/09/28 | Phase 1 | Completed | |||
2010/09/22 | Phase 3 | Withdrawn | Endo Pharmaceuticals | ||
2009/08/07 | Phase 4 | Completed | Endo Pharmaceuticals | ||
2009/07/24 | Not Applicable | UNKNOWN | |||
2009/07/02 | Phase 4 | Completed | MedVadis Research Corporation |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| XLCare Pharmaceuticals, Inc. | 72865-130 | ORAL | 5 mg in 1 1 | 5/7/2020 | |
| Amneal Pharmaceuticals LLC | 64896-697 | ORAL | 10 mg in 1 1 | 8/16/2022 | |
| Ranbaxy Pharmaceuticals Inc. | 63304-224 | ORAL | 40 mg in 1 1 | 9/13/2016 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1231 | ORAL | 5 mg in 1 1 | 1/10/2024 | |
| Camber Pharmaceuticals, Inc | 31722-929 | ORAL | 5 mg in 1 1 | 8/27/2020 | |
| Bryant Ranch Prepack | 63629-1925 | ORAL | 10 mg in 1 1 | 8/27/2020 | |
| Lake Erie Medical DBA Quality Care Products LLC | 35356-968 | ORAL | 10 mg in 1 1 | 1/8/2024 | |
| Amneal Pharmaceuticals LLC | 64896-695 | ORAL | 5 mg in 1 1 | 8/16/2022 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1317 | ORAL | 30 mg in 1 1 | 1/10/2024 | |
| Amneal Pharmaceuticals LLC | 64896-698 | ORAL | 15 mg in 1 1 | 8/16/2022 |
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 |
|---|---|---|---|---|---|
| OPANA ER | paladin pharma inc. | 02383454 | Tablet (Extended-Release) - Oral | 20 MG | N/A |
| NUMORPHAN INJECTION 1.5MG/ML | bristol-myers squibb canada | 01916505 | Liquid - Intramuscular
,
Subcutaneous
,
Intravenous | 1.5 MG / ML | 12/31/1993 |
| OPANA ER | paladin pharma inc. | 02383470 | Tablet (Extended-Release) - Oral | 40 MG | N/A |
| OPANA ER | paladin pharma inc. | 02383438 | Tablet (Extended-Release) - Oral | 10 MG | N/A |
| OPANA ER | paladin pharma inc. | 02383403 | Tablet (Extended-Release) - Oral | 5 MG | N/A |
| NUMORPHAN SUPPOSITORY 5MG | bristol-myers squibb canada | 01916513 | Suppository - Rectal | 5 MG | 12/31/1993 |
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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