Drugs / Oxymorphone
Oxymorphone
also known as
Opana ER · Oxymorphone ER · Opana · oxymorphone extended release · 14-hydroxydihydromorphinone · 7,8-dihydro-14-hydroxymorphinone · Dihydroxymorphinone · IDS-NO-003 · +14 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | OPANA | — | 2019-10-25 | fda.gov ↗ |
| Approved | US (FDA) | OPANA | — | 1959-04-02 | fda.gov ↗ |
Trials 22 · a red edge is where a trial was stopped
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00857428 | Nov 2007 | — | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT00857142 | Nov → Dec 2007 | pain agnosia | Sandoz | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05463367 | Jan 2021 → Jun 2025 overdue | chronic pain syndrome, opiate dependence, substance abuse | Northwestern University | Active not recruiting | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT02687451 | Apr 2016 → Jul 2020 | — | Endo USA Inc., a Keenova Therapeutics Company | Terminated | No outcome recorded |
| Phase 3 | NCT01210352 | Dec 2010 → Oct 2017 | — | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 3 | NCT01206907 | Oct 2010 → Dec 2013 | chronic pain syndrome | Endo USA Inc., a Keenova Therapeutics Company | Withdrawn | No outcome recorded |
| Phase 3 | NCT00801398 | Feb 2009 → Apr 2011 | — | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 3 | NCT00765856 | Nov 2008 → Feb 2010 | chronic pain syndrome | Endo USA Inc., a Keenova Therapeutics Company | Terminated | No outcome recorded |
| Phase 3 | NCT00225797 | Nov 2004 → Jul 2005 | chronic pain syndrome | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 3 | NCT00226421 | Oct 2004 → Aug 2005 | chronic pain syndrome | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 3 | NCT00226395 | Sep 2004 → Aug 2005 | — | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 3 | NCT00911261 | Aug 2003 → Mar 2005 | cancer, chronic pain syndrome, neuropathy, painful | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 3 | NCT00911287 | Jun 2003 → Jan 2004 | chronic pain syndrome | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 3 | NCT00904449 | Apr 2001 → Dec 2002 | — | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 3 | NCT00904280 | Mar 2001 → Jul 2003 | — | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT02741076 | Sep 2016 → Apr 2018 | opiate dependence, opioid abuse | Member Companies of the Opioid PMR Consortium | Terminated | No outcome recorded |
| Phase 4 | NCT00955110 | Jun → Sep 2009 | — | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 4 | NCT00930943 | May → Nov 2009 | chronic pain syndrome | MedVadis Research Corporation | Completed | No outcome recorded |
| Phase 4 | NCT00652093 | Mar 2008 → Nov 2010 | lumbar spinal stenosis | University of Rochester | Terminated | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06240390 | May → Aug 2024 | neuropathy, painful | Universidad Europea de Canarias | Withdrawn | No outcome recorded |
| — | NCT00945919 | Jul 2009 → Dec 2010 | chronic pain syndrome, neuropathy, painful | Icahn School of Medicine at Mount Sinai | Unknown | No outcome recorded |
| — | NCT00580294 | Nov 2007 → Aug 2008 | pain agnosia | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03579446 Background | Nov 2018 → Jun 2023 | hematopoietic and lymphoid cell neoplasm, metastatic malignant neoplasm | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03389750 Comparator | Mar 2018 → Jun 2022 | substance-related disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04681027 Comparator | Mar 2013 → Apr 2017 | chronic pain syndrome | Endo USA Inc., a Keenova Therapeutics Company | Suspended | No outcome recorded |
| Phase 3 | NCT00904085 Comparator | Apr → Jun 2003 | — | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02625181 Background | Jul 2016 → Nov 2017 | — | Vanderbilt University | Completed | No outcome recorded |
Evidence & citations 25 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | oxymorphone | “Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit” NCT00652093 ↗26“Intravenous Challenge Drug: Oxymorphone” NCT03389750 ↗ “Hydrocodone Oxymorphone (Opana®)” NCT06240390 ↗ “oxymorphone” NCT05463367 ↗ |
| Known as | 14-hydroxydihydromorphinone | ChEMBL registry synonym — accepted as the source's own label CHEMBL963 ↗ |
| Known as | 7,8-dihydro-14-hydroxymorphinone | ChEMBL registry synonym — accepted as the source's own label CHEMBL963 ↗ |
| Known as | Dihydroxymorphinone | ChEMBL registry synonym — accepted as the source's own label CHEMBL963 ↗ |
| Known as | IDS-NO-003 | ChEMBL registry synonym — accepted as the source's own label CHEMBL963 ↗ |
| Known as | NIH 10323 | ChEMBL registry synonym — accepted as the source's own label CHEMBL963 ↗ |
| Known as | NSC-19045 | ChEMBL registry synonym — accepted as the source's own label CHEMBL963 ↗ |
| Known as | Numorphan | ChEMBL registry synonym — accepted as the source's own label CHEMBL963 ↗ |
| Known as | Numorphan CR | “Numorphan® CR (Oxymorphone HCL Controlled Release)” NCT00904280 ↗ |
| Known as | OM-ER | “OBJECTIVE: To compare cognitive and psychomotor effects of oxymorphone extended release (OM-ER) versus oxycodone controlled release (OC-CR).” PMID 21102969 ↗ Nov 2010 |
| Known as | Opana | “The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended release tablets (Sandoz) with Opana extended release oxymorphone...” NCT00857142 ↗2“Oxymorphone, a potent mu-opioid pain medication approved by the Food and Drug Administration as Opana and Opana ER” NCT03389750 ↗ “Hydrocodone Oxymorphone (Opana®)” NCT06240390 ↗ |
| Known as | Opana ER | “A Study to Evaluate the Relative Bioavaility of Oxymorphone Hydrochloride 40 mg Extended-Release Tablets(Sandoz, Inc. Compared to Opana ER (Oxymorphone Hydrochloride)...” NCT00857142 ↗4“This project will explore the safety and feasibility of performing a successful intravenous patient controlled analgesia (IV PCA) Oxymorphone titration and conversion to oral...” NCT00945919 ↗ “OBJECTIVE: Determine the efficacy and tolerability of oxymorphone extended release (OPANA ER) in opioid-naive patients with moderate to severe chronic low back pain (CLBP).” PMID 17257473 ↗ Jan 2007 “The purpose of this study is to compare the subjective and objective effects of Oxymorphone ER (Opana ER) versus Oxycodone CR (Oxycontin).” NCT00955110 ↗ “Oxymorphone, a potent mu-opioid pain medication approved by the Food and Drug Administration as Opana and Opana ER” NCT03389750 ↗ |
| Known as | OPANA ER (oxymorphone HCl) Extended-Release Tablets | “OPANA® ER (oxymorphone HCl) Extended-Release Tablets” NCT04681027 ↗ |
| Known as | Opana IR | “Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit” NCT00652093 ↗ |
| Known as | opana: oxymorphone HCL | “opana: oxymorphone HCL” NCT00652093 ↗ |
| Known as | Oximorfona | ChEMBL registry synonym — accepted as the source's own label CHEMBL963 ↗ |
| Known as | Oxycodone hydrochloride impurity, oxymorphone- | ChEMBL registry synonym — accepted as the source's own label CHEMBL963 ↗ |
| Known as | Oxymorphone cii | ChEMBL registry synonym — accepted as the source's own label CHEMBL963 ↗ |
| Known as | Oxymorphone ER | “The purpose of this study is to evaluate the long-term safety and tolerability of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate...” NCT00904280 ↗3“The purpose of this study is to compare the subjective and objective effects of Oxymorphone ER (Opana ER) versus Oxycodone CR (Oxycontin).” NCT00955110 ↗ “Study Medication: Oxymorphone ER 5 mg, 10 mg, and 20 mg tablets. Rescue Medication: Oxymorphone IR 5 mg tablets.” NCT00911287 ↗ “Drug: Oxymorphone ER” NCT00904449 ↗ |
| Known as | oxymorphone extended release | “OBJECTIVE: To compare cognitive and psychomotor effects of oxymorphone extended release (OM-ER) versus oxycodone controlled release (OC-CR).” PMID 21102969 ↗ Nov 20101“Oxymorphone Extended Release Tablets in Opioid-Naïve Patients With Chronic Low Back Pain” NCT00225797 ↗ |
| Known as | oxymorphone HCl | “Drug: oxymorphone HCl” NCT01210352 ↗ |
| Known as | oxymorphone hydrochloride | “The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended release tablets (Sandoz) with Opana extended release oxymorphone...” NCT00857142 ↗ |
| Known as | Oxymorphone IR | “Study Medication: Oxymorphone ER 5 mg, 10 mg, and 20 mg tablets. Rescue Medication: Oxymorphone IR 5 mg tablets.” NCT00911287 ↗ |
| Modality | Small molecule | — CHEMBL963 ↗ |
| Route | Oral | “patients will receive daily oxymorphone ER by mouth (PO) q12h.” NCT00225797 ↗ |