MedPath

Oxymorphone

Generic Name
Oxymorphone
Brand Names
Opana
Drug Type
Small Molecule
Chemical Formula
C17H19NO4
CAS Number
76-41-5
Unique Ingredient Identifier
9VXA968E0C
Background

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
Associated Therapies
Perioperative analgesia, Obstetrical analgesia therapy

Safety, Tolerability, Effectiveness, and Pharmacokinetic Data in Opioid-experienced Children

Phase 3
Suspended
Conditions
Chronic Pain
Postsurgical Pain
Interventions
First Posted Date
2020-12-23
Last Posted Date
2020-12-23
Lead Sponsor
Endo Pharmaceuticals
Target Recruit Count
15
Registration Number
NCT04681027
Locations
🇺🇸

Endo Clinical Trial Site #3, Orange, California, United States

🇺🇸

Endo Clinical Trial Site #5, New Orleans, Louisiana, United States

🇺🇸

Endo Clinical Trial Site #1, Oklahoma City, Oklahoma, United States

and more 2 locations

Levorphanol as a Second Line Opioid in Reducing Pain in Patients With Cancer

Early Phase 1
Active, not recruiting
Conditions
Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Hematopoietic and Lymphoid Cell Neoplasm
Interventions
First Posted Date
2018-07-06
Last Posted Date
2025-03-25
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
43
Registration Number
NCT03579446
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects

Phase 3
Terminated
Conditions
Post-Operative Pain
Acute Pain
Interventions
First Posted Date
2016-02-22
Last Posted Date
2021-10-26
Lead Sponsor
Endo Pharmaceuticals
Target Recruit Count
28
Registration Number
NCT02687451
Locations
🇺🇸

Endo Clinical Trial Site #1, Dallas, Texas, United States

🇺🇸

Endo Clinical Trial Site #4, Houston, Texas, United States

🇺🇸

Endo Clinical Trial Site #2, Durham, North Carolina, United States

Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

Not Applicable
Completed
Conditions
Postoperative Nausea and Vomiting
Interventions
First Posted Date
2015-12-09
Last Posted Date
2019-03-07
Lead Sponsor
Vanderbilt University
Target Recruit Count
27034
Registration Number
NCT02625181
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects

Phase 3
Completed
Conditions
Post Operative Pain
Interventions
First Posted Date
2010-09-28
Last Posted Date
2021-08-20
Lead Sponsor
Endo Pharmaceuticals
Target Recruit Count
61
Registration Number
NCT01210352
Locations
🇺🇸

Endo Clinical Trial Site #3, Aurora, Colorado, United States

🇺🇸

Endo Clinical Trial Site #11, Oklahoma City, Oklahoma, United States

🇺🇸

Endo Clinical Trial Site #1, Little Rock, Arkansas, United States

and more 5 locations

Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions

Phase 1
Completed
Conditions
Pain
Interventions
First Posted Date
2010-09-28
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
42
Registration Number
NCT01210638
Locations
🇺🇸

Novum Pharmaceutical Research Services, Houston, Texas, United States

Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects

Phase 3
Withdrawn
Conditions
Chronic Pain
First Posted Date
2010-09-22
Last Posted Date
2012-08-17
Lead Sponsor
Endo Pharmaceuticals
Registration Number
NCT01206907

Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)

Phase 4
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-08-07
Last Posted Date
2017-10-05
Lead Sponsor
Endo Pharmaceuticals
Target Recruit Count
78
Registration Number
NCT00955110

A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone

Not Applicable
Conditions
Chronic Nociceptive Pain
Neuropathic Pain
Non-cancer Pain
First Posted Date
2009-07-24
Last Posted Date
2009-07-24
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Target Recruit Count
12
Registration Number
NCT00945919
Locations
🇺🇸

Mount Sinai School of Medicine, New York, New York, United States

Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning

Phase 4
Completed
Conditions
Chronic Pain
Interventions
First Posted Date
2009-07-02
Last Posted Date
2023-05-09
Lead Sponsor
MedVadis Research Corporation
Target Recruit Count
30
Registration Number
NCT00930943
Locations
🇺🇸

MedVadis Research Corporation, Wellesley Hills, Massachusetts, United States

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