Overview
Morphine, the main alkaloid of opium, was first obtained from poppy seeds in 1805. It is a potent analgesic, though its use is limited due to tolerance, withdrawal, and the risk of abuse. Morphine is still routinely used today, though there are a number of semi-synthetic opioids of varying strength such as codeine, fentanyl, methadone, hydrocodone, hydromorphone, meperidine, and oxycodone. Morphine was granted FDA approval in 1941.
Background
Morphine, the main alkaloid of opium, was first obtained from poppy seeds in 1805. It is a potent analgesic, though its use is limited due to tolerance, withdrawal, and the risk of abuse. Morphine is still routinely used today, though there are a number of semi-synthetic opioids of varying strength such as codeine, fentanyl, methadone, hydrocodone, hydromorphone, meperidine, and oxycodone. Morphine was granted FDA approval in 1941.
Indication
Morphine is used for the management of chronic, moderate to severe pain. Opiods, including morphine, are effective for the short term management of pain. Patients taking opioids long term may need to be monitored for the development of physical dependence, addiction disorder, and drug abuse.
Associated Conditions
- Chronic Pain
- Severe Pain
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/07/02 | Phase 3 | Withdrawn | Women and Infants Hospital of Rhode Island | ||
2020/06/26 | Phase 1 | Completed | |||
2020/06/24 | Not Applicable | Completed | |||
2020/06/12 | Phase 3 | Completed | |||
2020/06/11 | Phase 1 | Recruiting | University Hospital, Grenoble | ||
2020/05/14 | Phase 4 | Completed | |||
2020/04/24 | Phase 2 | Completed | |||
2020/04/10 | Phase 4 | Completed | |||
2020/03/18 | Phase 4 | Completed | |||
2020/03/10 | Phase 2 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi, USA LLC | 76045-007 | INTRAVENOUS, INTRAMUSCULAR | 8 mg in 1 mL | 8/10/2018 | |
| American Health Packaging | 60687-617 | ORAL | 15 mg in 1 1 | 9/29/2023 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0404 | ORAL | 100 mg in 5 mL | 11/15/2024 | |
| Nortec Development Associates, Inc. | 42689-006 | ORAL | 30 mg in 1 1 | 11/3/2023 | |
| Precision Dose, Inc. | 68094-356 | ORAL | 100 mg in 5 mL | 6/30/2023 | |
| Physicians Total Care, Inc. | 54868-4973 | ORAL | 30 mg in 1 1 | 1/11/2012 | |
| Bryant Ranch Prepack | 63629-1088 | ORAL | 30 mg in 1 1 | 10/31/2019 | |
| Bryant Ranch Prepack | 63629-1090 | ORAL | 100 mg in 1 1 | 5/18/2023 | |
| ANI Pharmaceuticals, Inc. | 62559-153 | ORAL | 1 g in 100 mL | 6/20/2017 | |
| STAT Rx USA LLC | 42549-602 | ORAL | 15 mg in 1 1 | 2/28/2012 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||