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.
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 |
|---|---|---|---|---|---|
2025/01/20 | Phase 4 | Recruiting | |||
2025/01/07 | Not Applicable | Recruiting | |||
2024/12/11 | Phase 3 | Recruiting | |||
2024/12/04 | Phase 4 | Not yet recruiting | |||
2024/12/04 | Phase 2 | Recruiting | |||
2024/11/25 | Phase 4 | Not yet recruiting | |||
2024/11/08 | Phase 2 | Active, not recruiting | |||
2024/10/22 | Not Applicable | Completed | Ondokuz Mayıs University | ||
2024/10/01 | Early Phase 1 | Recruiting | |||
2024/08/27 | Not Applicable | Recruiting | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| STAT RX USA LLC | 16590-597 | ORAL | 90 mg in 1 1 | 9/22/2011 | |
| Sun Pharmaceutical Industries, Inc. | 63304-450 | ORAL | 15 mg in 1 1 | 12/14/2023 | |
| Purdue Pharma LP | 59011-261 | ORAL | 30 mg in 1 1 | 3/23/2017 | |
| Upsher-Smith Laboratories, LLC | 0832-0228 | ORAL | 50 mg in 1 1 | 2/29/2024 | |
| Fresenius Kabi USA, LLC | 63323-455 | INTRAVENOUS, INTRAMUSCULAR | 5 mg in 1 mL | 12/30/2019 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0517 | ORAL | 100 mg in 5 mL | 11/15/2024 | |
| Bryant Ranch Prepack | 63629-2301 | ORAL | 20 mg in 1 mL | 1/6/2022 | |
| Padagis US LLC | 0574-7114 | RECTAL | 20 mg in 1 1 | 7/8/2019 | |
| Ascend Laboratories, LLC | 67877-671 | ORAL | 30 mg in 1 1 | 8/18/2021 | |
| Rhodes Pharmaceuticals L.P. | 42858-631 | ORAL | 30 mg in 1 1 | 12/27/2023 |
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 |
|---|---|---|---|---|---|
| Morphine Hydrochloride Tablets | 国药准字H63020015 | 化学药品 | 片剂 | 5/11/2020 | |
| Morphine Hydrochloride Tablets | 国药准字H63020014 | 化学药品 | 片剂 | 5/9/2020 | |
| Morphine Hydrochloride Tablets | 国药准字H20063220 | 化学药品 | 片剂 | 9/2/2020 | |
| Morphine Hydrochloride Tablets | 国药准字H20033010 | 化学药品 | 片剂 | 5/11/2020 | |
| Morphine Sulfate Injection | 国药准字H20010317 | 化学药品 | 注射剂 | 5/19/2020 | |
| Morphine Sulfate Injection | 国药准字H20010316 | 化学药品 | 注射剂 | 5/19/2020 | |
| Morphine Sulfate Injection | 国药准字H20010315 | 化学药品 | 注射剂 | 5/19/2020 | |
| Morphine Hydrochloride Sustained-release Tablets | 国药准字H10930001 | 化学药品 | 片剂(缓释) | 8/24/2020 | |
| Morphine Hydrochloride Sustained-release Tablets | 国药准字H10930078 | 化学药品 | 片剂(缓释) | 7/16/2020 | |
| Morphine Hydrochloride Sustained-release Tablets | 国药准字H10930002 | 化学药品 | 片剂(缓释) | 8/24/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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