Oxymorphone

Overview

An opioid analgesic with actions and uses similar to those of morphine, apart from an absence of cough suppressant activity. It is used in the treatment of moderate to severe pain, including pain in obstetrics. It may also be used as an adjunct to anesthesia (From Martindale, The Extra Pharmacopoeia, 30th ed, p1092). On June 8, 2017, FDA requested Endo Pharmaceuticals to remove the medication from the market due to opioid misuse and abuse risks associated with the product's injectable reformulation.

Indication

For the treatment of moderate-to-severe pain.

Associated Conditions

Anxiety
Severe Pain
Moderate Pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety, Tolerability, Effectiveness, and Pharmacokinetic Data in Opioid-experienced Children	2020/12/23	NCT04681027	Phase 3	Suspended	Endo Pharmaceuticals
Levorphanol as a Second Line Opioid in Reducing Pain in Patients With Cancer	2018/07/06	NCT03579446	Early Phase 1	Terminated	M.D. Anderson Cancer Center
Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects	2016/02/22	NCT02687451	Phase 3	Terminated	Endo Pharmaceuticals
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis	2015/12/09	NCT02625181	Not Applicable	Completed	Vanderbilt University
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects	2010/09/28	NCT01210352	Phase 3	Completed	Endo Pharmaceuticals
Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions	2010/09/28	NCT01210638	Phase 1	Completed	Roxane Laboratories
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects	2010/09/22	NCT01206907	Phase 3	Withdrawn	Endo Pharmaceuticals
Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)	2009/08/07	NCT00955110	Phase 4	Completed	Endo Pharmaceuticals
A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone	2009/07/24	NCT00945919	Not Applicable	UNKNOWN	Icahn School of Medicine at Mount Sinai
Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning	2009/07/02	NCT00930943	Phase 4	Completed	MedVadis Research Corporation

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
OXYMORPHONE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	72865-130	ORAL	5 mg in 1 1	5/7/2020
Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	64896-697	ORAL	10 mg in 1 1	8/16/2022
Oxymorphone hydrochloride	Ranbaxy Pharmaceuticals Inc.	63304-224	ORAL	40 mg in 1 1	9/13/2016
Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	0115-1231	ORAL	5 mg in 1 1	1/10/2024
OXYMORPHONE HYDROCHLORIDE	Camber Pharmaceuticals, Inc	31722-929	ORAL	5 mg in 1 1	8/27/2020
OXYMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	63629-1925	ORAL	10 mg in 1 1	8/27/2020
Oxymorphone Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	35356-968	ORAL	10 mg in 1 1	1/8/2024
Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	64896-695	ORAL	5 mg in 1 1	8/16/2022
Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	0115-1317	ORAL	30 mg in 1 1	1/10/2024
Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	64896-698	ORAL	15 mg in 1 1	8/16/2022

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
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
OPANA ER	paladin pharma inc.	02383454	Tablet (Extended-Release) - Oral	20 MG	N/A
NUMORPHAN INJECTION 1.5MG/ML	bristol-myers squibb canada	01916505	Liquid - Intramuscular , Subcutaneous , Intravenous	1.5 MG / ML	12/31/1993
OPANA ER	paladin pharma inc.	02383470	Tablet (Extended-Release) - Oral	40 MG	N/A
OPANA ER	paladin pharma inc.	02383438	Tablet (Extended-Release) - Oral	10 MG	N/A
OPANA ER	paladin pharma inc.	02383403	Tablet (Extended-Release) - Oral	5 MG	N/A
NUMORPHAN SUPPOSITORY 5MG	bristol-myers squibb canada	01916513	Suppository - Rectal	5 MG	12/31/1993

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

AI-Powered Research

Premium Access