oxymorphone
Trade name: opana
Approved
Apr 2, 1959
Oxymorphone is an analgesic that is FDA approved for the treatment of moderate to severe pain. It is also indicated for relief of anxiety in patients with dyspnea associated with pulmonary edema secondary to acute left ventricular dysfunction. Oxymorphone (brand names Opana, Numorphan, Numorphone) is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. Adverse reactions (≥ 2% of patients): seen with the immediate release tablet formulation Nausea, pyrexia, somnolence, vomiting, pruritus, headache, dizziness, constipation, and confusion. Concomitant use with serotonergic drugs may result in serotonin syndrome. Avoid use of mixed agonist/antagonist and partial agonist opioid analgesics with Opana because they may reduce analgesic effect of Opana or precipitate withdrawal symptoms. — NCATS
Clinical trial activity
25 trials · 13 clinical orgs · 15 marketing orgs
Earliest trial started Mar 1, 2001 (NCT00904280)
Timeline
1950s
- Apr 2, 1959
Endo Pharmaceuticals — Earliest FDA Approval
- Apr 2, 1959
Endo Pharmaceuticals — NDA Secondary Org
- Apr 2, 1959
Endo Pharmaceuticals — NDA Organization
2000s
- Jan 1, 2001
Endo Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
- Jun 22, 2006
Bristol-Myers Squibb — NDA Secondary Org
- Jun 22, 2006
Endo Pharmaceuticals — Marketing Organization
- Jan 1, 2007
Earliest Phase 1 Sponsor(trial)
2010s
- Jun 14, 2010
Impax Laboratories — Marketing Organization
- Sep 27, 2010
West-Ward Pharmaceutical — Marketing Organization
- Sep 27, 2010
Hikma — Marketing Organization
- Dec 13, 2010
Actavis — Marketing Organization
- Feb 15, 2011
Teva — Marketing Organization
- Jan 30, 2013
Avanthi Pharma — Marketing Organization
- Apr 25, 2013
Specgx Llc — Marketing Organization
- Oct 24, 2014
Par Pharmaceuticals — Marketing Organization
- Dec 15, 2014
Epic Pharma Llc — Marketing Organization
- Apr 24, 2015
Sun Pharmaceuticals — Marketing Organization
- Apr 26, 2016
Aurobindo Pharma — Marketing Organization
- Jan 1, 2018
Earliest Phase 2 Sponsor(trial)
- Feb 2, 2018
Ascent Pharmahealth — Marketing Organization
- Feb 2, 2018
Allergan PLC (2015) — Marketing Organization
Indications
Studied for
- Acute Pain · Phase 3
- Cancer Pain · Phase 3
- Chronic Disease · Phase 3
- Chronic Pain · Phase 4
- Healthy Volunteers · Phase 4
- Low Back Pain · Phase 3
- Narcotic-Related Disorders · Phase 4
- Neoplasms · Phase 3
- Neuralgia · Phase 3
- Opioid-Related Disorders · Phase 4
- Postoperative Pain · Phase 3
- Spinal Stenosis · Phase 4
- Substance-Related Disorders · Phase 4
Mechanism of action
Approval history
- approvedApr 2, 1959
Chemistry & pharmacology
SMILES
CN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5- Mol. weight
- 301.34 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral, Topical
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
Yes
Sources
- ChEMBLCHEMBL963 ↗
- WikipediaOxymorphone ↗
- NCATS9VXA968E0C ↗
- ChEMBLCHEMBL1200794 ↗
Also known as
- 14-hydroxydihydromorphinone
- 14-hydroxydihydromorphinone
- 14-hydroxydihydromorphinone
- dihydrohydroxymorphinone
- dihydrohydroxymorphinone
- en3202
- en3202
- numorphan
- numorphan
- opana
- opana
- opana
- opana
- opana er
- opana er
- oximorphonum
- oximorphonum
- oxymorphine
- oxymorphine
- oxymorphone
- oxymorphone
- oxymorphone
- oxymorphone
- oxymorphone
- oxymorphone
- oxymorphone
- oxymorphone
- oxymorphone
- oxymorphone
- (-)-oxymorphone
- oxymorphone hcl
- oxymorphone hcl
- oxymorphone hcl
- oxymorphone hydrochloride
- oxymorphone hydrochloride
- oxymorphone hydrochloride
- oxymorphone hydrochloride
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03389750 | Phase 2 | Mar 15, 2018 | Columbia University, University of Kentucky |
| NCT02625181 | N/A | Jul 1, 2016 | University of Washington, Vanderbilt University |
| NCT02687451 | Phase 3 | Mar 1, 2016 | Endo Pharmaceuticals |
| NCT02741076 | Phase 4 | Feb 10, 2016 | Member Companies of the Opioid PMR Consortium |
| NCT04681027 | Phase 3 | Mar 11, 2013 | Endo Pharmaceuticals |
| NCT01210352 | Phase 3 | Dec 1, 2010 | Endo Pharmaceuticals |
| NCT01206907 | Phase 3 | Oct 1, 2010 | Endo Pharmaceuticals |
| NCT00945919 | N/A | Jul 1, 2009 | Endo Pharmaceuticals, Icahn School of Medicine at Mount Sinai |
| NCT00955110 | Phase 4 | Jun 1, 2009 | Endo Pharmaceuticals, Kendle International Inc. |
| NCT00930943 | Phase 4 | May 1, 2009 | MedVadis Research Corporation |
| NCT00801398 | Phase 3 | Dec 1, 2008 | Endo Pharmaceuticals |
| NCT00765856 | Phase 3 | Oct 1, 2008 | Endo Pharmaceuticals |
| NCT01210638 | Phase 1 | Jun 1, 2008 | Novum Pharmaceutical Research Services, Roxane Laboratories |
| NCT00652093 | Phase 4 | Mar 1, 2008 | Endo Pharmaceuticals, University of Rochester |
| NCT00580294 | N/A | Nov 1, 2007 | Endo Pharmaceuticals, Icahn School of Medicine at Mount Sinai |
| NCT00857142 | Phase 1 | Nov 1, 2007 | Novum Pharmaceutical Research Services, Sandoz |
| NCT00857428 | Phase 1 | Nov 1, 2007 | Novum Pharmaceutical Research Services, Sandoz |
| NCT00225797 | Phase 3 | Nov 1, 2004 | Endo Pharmaceuticals |
| NCT00226421 | Phase 3 | Oct 1, 2004 | Endo Pharmaceuticals |
| NCT00226395 | Phase 3 | Sep 1, 2004 | Endo Pharmaceuticals |
Organizations
Research & Development (13)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Endo Pharmaceuticals | For profit | 18 | 15 | 3 | 2001 |
| Novum Pharmaceutical Research Services | For profit | 3 | 0 | 1 | 2007 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 2 | 2 | 1 | 2007 |
| Sandoz | For profit | 2 | 2 | 1 | 2007 |
| Columbia University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Kendle International Inc. | For profit | 1 | 0 | 1 | 2009 |
| MedVadis Research Corporation | For profit | 1 | 1 | 1 | 2009 |
| Member Companies of the Opioid PMR Consortium | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Roxane Laboratories | For profit | 1 | 1 | 1 | 2008 |
| University of Kentucky | Academic/Hospital | 1 | 0 | 1 | 2018 |
| University of Rochester | Academic/Hospital | 1 | 1 | 1 | 2008 |
| University of Washington | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Vanderbilt University | Academic/Hospital | 1 | 1 | 1 | 2016 |
Marketing (18)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | MKTG | Dec 13, 2010 |
| Allergan PLC (2015) | For profit | MKTG | Feb 2, 2018 |
| Ascent Pharmahealth | For profit | MKTG | Feb 2, 2018 |
| Aurobindo Pharma | For profit | MKTG | Apr 26, 2016 |
| Avanthi Pharma | For profit | MKTG | Jan 30, 2013 |
| Bristol-Myers Squibb | For profit | NDA2 | Jun 22, 2006 |
| Endo Pharmaceuticals | For profit | NDA2 | Apr 2, 1959 |
| Endo Pharmaceuticals | For profit | NDA | Apr 2, 1959 |
| Endo Pharmaceuticals | For profit | MKTG | Jun 22, 2006 |
| Epic Pharma Llc | For profit | MKTG | Dec 15, 2014 |
| Hikma | For profit | MKTG | Sep 27, 2010 |
| Hikma | For profit | SYN | Sep 27, 2010 |
| Impax Laboratories | For profit | MKTG | Jun 14, 2010 |
| Par Pharmaceuticals | For profit | MKTG | Oct 24, 2014 |
| Specgx Llc | For profit | MKTG | Apr 25, 2013 |
| Sun Pharmaceuticals | For profit | MKTG | Apr 24, 2015 |
| Teva | For profit | MKTG | Feb 15, 2011 |
| West-Ward Pharmaceutical | For profit | MKTG | Sep 27, 2010 |