oxymorphone

Trade name: opana

Small moleculeapproved

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

Phase 1
3
Phase 2
15
Phase 3
14
Phase 4
4

Earliest trial started Mar 1, 2001 (NCT00904280)

Timeline

1950s

  1. Apr 2, 1959

    Endo Pharmaceuticals — Earliest FDA Approval

  2. Apr 2, 1959

    Endo Pharmaceuticals — NDA Secondary Org

  3. Apr 2, 1959

    Endo Pharmaceuticals — NDA Organization

2000s

  1. Jan 1, 2001

    Endo Pharmaceuticals — Earliest Phase 3 Sponsor(trial)

  2. Jun 22, 2006

    Bristol-Myers Squibb — NDA Secondary Org

  3. Jun 22, 2006

    Endo Pharmaceuticals — Marketing Organization

  4. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jun 14, 2010

    Impax Laboratories — Marketing Organization

  2. Sep 27, 2010

    West-Ward Pharmaceutical — Marketing Organization

  3. Sep 27, 2010

    Hikma — Marketing Organization

  4. Dec 13, 2010

    Actavis — Marketing Organization

  5. Feb 15, 2011

    Teva — Marketing Organization

  6. Jan 30, 2013

    Avanthi Pharma — Marketing Organization

  7. Apr 25, 2013

    Specgx Llc — Marketing Organization

  8. Oct 24, 2014

    Par Pharmaceuticals — Marketing Organization

  9. Dec 15, 2014

    Epic Pharma Llc — Marketing Organization

  10. Apr 24, 2015

    Sun Pharmaceuticals — Marketing Organization

  11. Apr 26, 2016

    Aurobindo Pharma — Marketing Organization

  12. Jan 1, 2018

    Earliest Phase 2 Sponsor(trial)

  13. Feb 2, 2018

    Ascent Pharmahealth — Marketing Organization

  14. Feb 2, 2018

    Allergan PLC (2015) — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedApr 2, 1959

Chemistry & pharmacology

Loading structure…

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

Black box warning

Sources

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 IDPhaseStart dateSponsor(s)
NCT03389750Phase 2Mar 15, 2018Columbia University, University of Kentucky
NCT02625181N/AJul 1, 2016University of Washington, Vanderbilt University
NCT02687451Phase 3Mar 1, 2016Endo Pharmaceuticals
NCT02741076Phase 4Feb 10, 2016Member Companies of the Opioid PMR Consortium
NCT04681027Phase 3Mar 11, 2013Endo Pharmaceuticals
NCT01210352Phase 3Dec 1, 2010Endo Pharmaceuticals
NCT01206907Phase 3Oct 1, 2010Endo Pharmaceuticals
NCT00945919N/AJul 1, 2009Endo Pharmaceuticals, Icahn School of Medicine at Mount Sinai
NCT00955110Phase 4Jun 1, 2009Endo Pharmaceuticals, Kendle International Inc.
NCT00930943Phase 4May 1, 2009MedVadis Research Corporation
NCT00801398Phase 3Dec 1, 2008Endo Pharmaceuticals
NCT00765856Phase 3Oct 1, 2008Endo Pharmaceuticals
NCT01210638Phase 1Jun 1, 2008Novum Pharmaceutical Research Services, Roxane Laboratories
NCT00652093Phase 4Mar 1, 2008Endo Pharmaceuticals, University of Rochester
NCT00580294N/ANov 1, 2007Endo Pharmaceuticals, Icahn School of Medicine at Mount Sinai
NCT00857142Phase 1Nov 1, 2007Novum Pharmaceutical Research Services, Sandoz
NCT00857428Phase 1Nov 1, 2007Novum Pharmaceutical Research Services, Sandoz
NCT00225797Phase 3Nov 1, 2004Endo Pharmaceuticals
NCT00226421Phase 3Oct 1, 2004Endo Pharmaceuticals
NCT00226395Phase 3Sep 1, 2004Endo Pharmaceuticals
Showing 20 of 25 trials
Page 1 / 2

Organizations

Research & Development (13)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Endo PharmaceuticalsFor profit181532001
Novum Pharmaceutical Research ServicesFor profit3012007
Icahn School of Medicine at Mount SinaiAcademic/Hospital2212007
SandozFor profit2212007
Columbia UniversityAcademic/Hospital1112018
Kendle International Inc.For profit1012009
MedVadis Research CorporationFor profit1112009
Member Companies of the Opioid PMR ConsortiumAcademic/Hospital1112016
Roxane LaboratoriesFor profit1112008
University of KentuckyAcademic/Hospital1012018
University of RochesterAcademic/Hospital1112008
University of WashingtonAcademic/Hospital1012016
Vanderbilt UniversityAcademic/Hospital1112016
13 organizations
Page 1 / 1

Marketing (18)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGDec 13, 2010
Allergan PLC (2015)For profitMKTGFeb 2, 2018
Ascent PharmahealthFor profitMKTGFeb 2, 2018
Aurobindo PharmaFor profitMKTGApr 26, 2016
Avanthi PharmaFor profitMKTGJan 30, 2013
Bristol-Myers SquibbFor profitNDA2Jun 22, 2006
Endo PharmaceuticalsFor profitNDA2Apr 2, 1959
Endo PharmaceuticalsFor profitNDAApr 2, 1959
Endo PharmaceuticalsFor profitMKTGJun 22, 2006
Epic Pharma LlcFor profitMKTGDec 15, 2014
HikmaFor profitMKTGSep 27, 2010
HikmaFor profitSYNSep 27, 2010
Impax LaboratoriesFor profitMKTGJun 14, 2010
Par PharmaceuticalsFor profitMKTGOct 24, 2014
Specgx LlcFor profitMKTGApr 25, 2013
Sun PharmaceuticalsFor profitMKTGApr 24, 2015
TevaFor profitMKTGFeb 15, 2011
West-Ward PharmaceuticalFor profitMKTGSep 27, 2010