Overview
Hydromorphone is a pure opioid, a semi-synthetic hydrogenated ketone derivative of morphine that has been available clinically since 1920. Structurally, hydromorphone derived from morphine in the modification of the hydroxyl group in the carbon 6 to a carbonyl and the absence of a double bond between the carbon 7 and 8. Due to these modifications, it presents a very high potency and comparable side effect profile to the parent compound. Even though hydromorphone does not present a 6-hydroxyl group, it is categorized under the family of phenanthrenes and it is considered a chemical under the schedule II (medical purposes with high addiction potential). The first reported approved product containing hydromorphone in the form of hydromorphone hydrochloride was developed by Fresenius Kabi USA and FDA approved in 1984.
Background
Hydromorphone is a pure opioid, a semi-synthetic hydrogenated ketone derivative of morphine that has been available clinically since 1920. Structurally, hydromorphone derived from morphine in the modification of the hydroxyl group in the carbon 6 to a carbonyl and the absence of a double bond between the carbon 7 and 8. Due to these modifications, it presents a very high potency and comparable side effect profile to the parent compound. Even though hydromorphone does not present a 6-hydroxyl group, it is categorized under the family of phenanthrenes and it is considered a chemical under the schedule II (medical purposes with high addiction potential). The first reported approved product containing hydromorphone in the form of hydromorphone hydrochloride was developed by Fresenius Kabi USA and FDA approved in 1984.
Indication
Hydromorphone is indicated for the management of moderate to severe acute pain and severe chronic pain. Due to its addictive potential and overdose risk, hydromorphone is only prescribed when other first-line treatments have failed. The WHO has proposed a three-step ladder for the management of pain in which it is suggested to start with a non-opioid medication followed by addition of weak opioids to the non-opioid treatment for moderate pain and finishing in the use of strong opioids such as hydromorphone along with the existing regimen for cases of severe pain. Off-label, hydromorphone can be administered for the suppression of refractory cough.
Associated Conditions
- Neuropathic Pain
- Refractory Chronic Cough
- Moderate to severe pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/04/29 | Phase 1 | Recruiting | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
2025/03/11 | Phase 4 | Recruiting | |||
2025/01/21 | Phase 2 | Recruiting | Wuhan Union Hospital, China | ||
2025/01/20 | Phase 4 | Recruiting | |||
2024/11/01 | Phase 4 | Active, not recruiting | University of Tennessee Graduate School of Medicine | ||
2024/10/01 | Early Phase 1 | Recruiting | |||
2024/07/29 | Phase 4 | Recruiting | |||
2024/05/13 | Phase 2 | Recruiting | |||
2024/05/09 | Phase 1 | Terminated | |||
2024/03/20 | Phase 4 | Recruiting | The Fourth Affiliated Hospital of Zhejiang University School of Medicine |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Teva Parenteral Medicines, Inc. | 0703-0018 | INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR | 10 mg in 1 mL | 9/21/2022 | |
Hospira, Inc. | 0409-1312 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 2 mg in 1 mL | 12/26/2023 | |
Ascent Pharmaceuticals, Inc. | 43602-266 | ORAL | 8 mg in 1 1 | 9/24/2020 | |
Akorn | 17478-540 | INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR | 10 mg in 1 mL | 6/1/2020 | |
Teva Parenteral Medicines, Inc. | 0703-0110 | INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR | 10 mg in 1 mL | 9/21/2022 | |
Physicians Total Care, Inc. | 54868-6387 | ORAL | 8 mg in 1 1 | 1/28/2013 | |
H.J. Harkins Company, Inc. | 52959-413 | ORAL | 8 mg in 1 1 | 12/8/2011 | |
Bryant Ranch Prepack | 72162-1081 | ORAL | 2 mg in 1 1 | 5/10/2023 | |
STAT Rx USA LLC | 16590-942 | ORAL | 8 mg in 1 1 | 11/8/2011 | |
American Health Packaging | 60687-590 | ORAL | 4 mg in 1 1 | 12/11/2023 |
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 |
---|---|---|---|---|---|
Hydromorphone Hydrochloride Sustained-release Tablets | 国药准字H20234714 | 化学药品 | 片剂 | 12/29/2023 | |
Hydromorphone Hydrochloride Sustained-release Tablets | 国药准字H20234712 | 化学药品 | 片剂 | 12/29/2023 | |
Hydromorphone Hydrochloride Sustained-release Tablets | 国药准字H20234713 | 化学药品 | 片剂 | 12/29/2023 | |
Hydromorphone Hydrochloride Injection | 国药准字H20120094 | 化学药品 | 注射剂 | 8/11/2022 | |
Hydromorphone Hydrochloride Injection | 国药准字H20120100 | 化学药品 | 注射剂 | 8/15/2022 | |
Hydromorphone Hydrochloride Injection | 国药准字H20174033 | 化学药品 | 注射剂 | 8/15/2022 | |
Hydromorphone Hydrochloride Injection | 国药准字H20217021 | 化学药品 | 注射剂 | 8/15/2022 | |
Hydromorphone Hydrochloride Injection | 国药准字H20217022 | 化学药品 | 注射剂 | 8/15/2022 | |
Hydromorphone Hydrochloride Injection | 国药准字H20120095 | 化学药品 | 注射剂 | 8/11/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |