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 |
|---|---|---|---|---|---|
2022/01/11 | Phase 2 | UNKNOWN | |||
2021/12/09 | Early Phase 1 | Completed | |||
2021/12/03 | Phase 1 | Recruiting | |||
2021/11/30 | Phase 3 | Completed | Oslo University Hospital | ||
2021/11/11 | Not Applicable | Active, not recruiting | |||
2021/11/03 | Not Applicable | Completed | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||
2021/10/26 | Phase 4 | UNKNOWN | Sonoran Spine Research and Education Foundation | ||
2021/10/13 | Not Applicable | Completed | |||
2021/10/11 | Phase 4 | Recruiting | Zhongda Hospital | ||
2021/10/06 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Major Pharmaceuticals | 0904-6557 | ORAL | 15 mg in 1 1 | 1/3/2019 | |
| SpecGx LLC | 0406-8320 | ORAL | 200 mg in 1 1 | 1/30/2023 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-1170 | ORAL | 10 mg in 5 mL | 1/18/2021 | |
| Fresenius Kabi, USA LLC | 76045-008 | INTRAVENOUS, INTRAMUSCULAR | 10 mg in 1 mL | 8/10/2018 | |
| Bryant Ranch Prepack | 71335-0676 | ORAL | 30 mg in 1 1 | 10/31/2019 | |
| Tris Pharma Inc | 27808-082 | ORAL | 20 mg in 1 mL | 7/31/2022 | |
| SpecGx LLC | 0406-8003 | ORAL | 20 mg in 1 mL | 1/30/2023 | |
| Mayne Pharma Commercial LLC | 51862-617 | ORAL | 30 mg in 1 1 | 7/5/2023 | |
| Bryant Ranch Prepack | 72162-1791 | ORAL | 100 mg in 1 1 | 9/8/2023 | |
| STAT RX USA LLC | 16590-885 | ORAL | 200 mg in 1 1 | 6/15/2011 |
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 |
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| 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. | |||||