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.
Background
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/12/23 | Phase 3 | Suspended | Endo Pharmaceuticals | ||
2018/07/06 | Early Phase 1 | Active, not recruiting | |||
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2010/09/22 | Phase 3 | Withdrawn | Endo Pharmaceuticals | ||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. | |||||