MedPath

Hydromorphone

Generic Name
Hydromorphone
Brand Names
Dilaudid, Exalgo, Hydromorph Contin, Hydromorphone Hp Forte
Drug Type
Small Molecule
Chemical Formula
C17H19NO3
CAS Number
466-99-9
Unique Ingredient Identifier
Q812464R06

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.
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