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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/17 | Not Applicable | Not yet recruiting | The Second Hospital of Anhui Medical University | ||
2025/06/17 | Not Applicable | Recruiting | |||
2025/06/10 | Not Applicable | Completed | |||
2025/06/04 | Not Applicable | Active, not recruiting | |||
2025/05/25 | Not Applicable | Recruiting | |||
2025/05/22 | Phase 2 | Not yet recruiting | Ipsita Goswami | ||
2025/05/21 | Phase 4 | Recruiting | Walter Reed Army Institute of Research (WRAIR) | ||
2025/04/29 | Phase 3 | Recruiting | Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd | ||
2025/04/27 | Not Applicable | Recruiting | The Second Hospital of Anhui Medical University | ||
2025/04/20 | Phase 4 | Recruiting | Meri Mirceta |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Rhodes Pharmaceuticals L.P. | 42858-515 | ORAL | 15 mg in 1 1 | 12/27/2023 | |
| Bryant Ranch Prepack | 63629-1091 | ORAL | 200 mg in 1 1 | 10/31/2019 | |
| Quality Care Products LLC | 49999-848 | ORAL | 15 mg in 1 1 | 1/6/2020 | |
| Cantrell Drug Company | 52533-059 | INTRAVENOUS | 1 mg in 1 mL | 10/20/2014 | |
| Bryant Ranch Prepack | 71335-0707 | ORAL | 60 mg in 1 1 | 10/31/2019 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0235 | ORAL | 15 mg in 1 1 | 9/1/2018 | |
| Hospira, Inc. | 0409-1890 | INTRAVENOUS | 2 mg in 1 mL | 3/30/2023 | |
| STAT RX USA LLC | 16590-697 | ORAL | 20 mg in 1 1 | 6/15/2011 | |
| Bryant Ranch Prepack | 63629-1965 | ORAL | 10 g in 1000 mL | 2/8/2021 | |
| Upsher-Smith Laboratories, LLC | 0832-0225 | ORAL | 10 mg in 1 1 | 2/29/2024 |
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 |
|---|---|---|---|---|---|
| MST CONTINUS TABLET 10 mg | SIN05506P | TABLET, FILM COATED | 10 mg | 3/4/1991 | |
| MORPHINE SULFATE KALCEKS SOLUTION FOR INJECTION 10MG/ML | SIN16891P | INJECTION, SOLUTION | 10.00mg/mL | 10/20/2023 | |
| DBL MORPHINE SULFATE INJECTION BP 10 mg/ml | SIN00757P | INJECTION | 10 mg/ml | 5/4/1988 | |
| ORAMORPH SYRUP 2MG/ML | SIN16036P | SYRUP | 2MG/ML | 10/30/2020 | |
| Morphine-hameln 10 mg/ml Injection | SIN13598P | INJECTION, SOLUTION | 10mg | 2/9/2009 | |
| SOOV CREAM | SIN08901P | CREAM | 1.00% w/w | 9/4/1996 | |
| MST CONTINUS TABLET 30 mg | SIN05508P | TABLET, FILM COATED | 30 mg | 3/4/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Morphine Sulfate Oral Solution | 国药准字H20080713 | 化学药品 | 口服溶液剂 | 3/29/2023 | |
| Morphine Sulfate Oral Solution | 国药准字H20080714 | 化学药品 | 口服溶液剂 | 3/29/2023 | |
| Morphine Sulfate Tablets | 国药准字H10950106 | 化学药品 | 片剂 | 5/19/2020 | |
| Morphine Sulfate Tablets | 国药准字H10950105 | 化学药品 | 片剂 | 5/19/2020 | |
| Morphine Sulfate Tablets | 国药准字H10950107 | 化学药品 | 片剂 | 5/19/2020 | |
| Morphine Sulphate Sustained-release Tablets | 国药准字HJ20130901 | 化学药品 | 片剂 | 6/14/2024 | |
| Morphine Sulphate Sustained-release Tablets | 国药准字HJ20130903 | 化学药品 | 片剂 | 8/6/2024 | |
| Morphine Sulphate Sustained-release Tablets | 国药准字HJ20130904 | 化学药品 | 片剂 | 8/6/2024 | |
| Morphine Sulphate Sustained-release Tablets | 国药准字HJ20130902 | 化学药品 | 片剂 | 3/25/2021 | |
| Morphine Sulphate Sustained-release Tablets | 国药准字H10980062 | 化学药品 | 片剂 | 5/9/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| UNI-MORPHINE SYRUP (ALCOHOL FREE) 10MG/5ML | N/A | europharm lab co ltd | N/A | N/A | 11/12/2015 |
| UNI-MORPHINE SYRUP (ALCOHOL FREE) 50MG/5ML | N/A | europharm lab co ltd | N/A | N/A | 11/12/2015 |
| UNI-MORPHINE SYRUP (ALCOHOL FREE) 5MG/5ML | N/A | europharm lab co ltd | N/A | N/A | 11/12/2015 |