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Oxymorphone

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

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.

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

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2020/12/23
Phase 3
Suspended
Endo Pharmaceuticals
2018/07/06
Early Phase 1
Active, not recruiting
2016/02/22
Phase 3
Terminated
Endo Pharmaceuticals
2015/12/09
Not Applicable
Completed
2010/09/28
Phase 3
Completed
Endo Pharmaceuticals
2010/09/28
Phase 1
Completed
2010/09/22
Phase 3
Withdrawn
Endo Pharmaceuticals
2009/08/07
Phase 4
Completed
Endo Pharmaceuticals
2009/07/24
Not Applicable
UNKNOWN
2009/07/02
Phase 4
Completed
MedVadis Research Corporation

FDA Drug Approvals

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