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
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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 · 1 met primary | ||||||
| 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| Phase 3 | NCT01206907 | Oct 2010 → Dec 2013 | chronic pain syndrome | Endo USA Inc., a Keenova Therapeutics Company | Withdrawn | No outcome recorded |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 | Met primary |
| 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 · 1 met primary · 2 missed | ||||||
| Phase 4 | NCT02741076 | Sep 2016 → Apr 2018 | opiate dependence, opioid abuse | Member Companies of the Opioid PMR Consortium | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00955110 | Jun → Sep 2009 | — | Endo USA Inc., a Keenova Therapeutics Company | Completed | Met primary |
| Phase 4 | NCT00930943 | May → Nov 2009 | chronic pain syndrome | MedVadis Research Corporation | Completed | Missed primary |
| Phase 4 | NCT00652093 | Mar 2008 → Nov 2010 | lumbar spinal stenosis | University of Rochester | Terminated | Missed primary |
| Phase not applicable3 trials | ||||||
| — | NCT06240390 | May → Aug 2024 | neuropathy, painful | Universidad Europea de Canarias | Withdrawn | No outcome recorded Stop: Enrollment |
| — | 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 |
| Comparator or background therapy5 trials | ||||||
| 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 2 | NCT03389750 Comparator | Mar 2018 → Jun 2022 | substance-related disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| 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 |
| — | NCT02625181 Background | Jul 2016 → Nov 2017 | — | Vanderbilt University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2010-07-22 | Impax Laboratories, LLC | Regulatory Impax Laboratories Receives Final FDA Approval for Generic OPANA(R) ER Tablets amneal.com ↗
HAYWARD, Calif., Jul 22, 2010 (BUSINESS WIRE) -- Impax Laboratories, Inc. (NASDAQ:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of OPANA(R) ER (oxymorphone hydrochloride) Extended Release 30mg tablet. |
| 2010-05-14 | Impax Laboratories, LLC | Regulatory Impax Laboratories Receives Tentative FDA Approval for Generic Opana(R) ER 5, 7.5, 10, 15, 20, 30 and 40 mg Tablets amneal.com ↗
Impax Laboratories, Inc.(NASDAQ: IPXL) today confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug Application (ANDA) for generic version of Opana(R) ER (oxymorphone hydrochloride) 5, 7.5, 10, 15, 20, 30 and 40 mg tablets. |
| 2007-12-17 | Impax Laboratories, LLC | Regulatory IMPAX Announces FDA Acceptance of ANDA for Generic Version of Opana(R) ER amneal.com ↗ |
| 2007-10-04 | Impax Laboratories, LLC | Regulatory IMPAX Comments on Status of ANDA for Generic Opana(R) ER amneal.com ↗
Following an acceptance for filing by the FDA the Company was informed by the agency that it has rescinded its initial acceptance. |
All press releases naming this drug 12 releases
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 ↗ |