Overview
Fentanyl, a potent opioid agonist, was developed in the 1950s to fill a need for strong and rapid analgesia. Because of these characteristics, fentanyl is commonly used to treat chronic cancer pain or in anesthesia. Fentanyl is related to other opioids like morphine and oxycodone. Fentanyl's high potency has also made it a common adulterant in illicit drugs, especially heroin. In 2017, 47600 overdose deaths in the United States involved some opioid (over 2/3 of all overdose deaths). Opioid overdoses kill an average of 11 Canadians daily. Fentanyl was FDA approved in 1968.
Indication
Fentanyl intravenous or intramuscular injections are indicated for short term analgesia during induction, maintenance, and recovery from general or regional anesthesia. These injections are also used with a neuroleptic for premedication, induction, and as an adjunct to maintenance of anesthesia. Finally, fentanyl intravenous or intramuscular injections are used with oxygen for anesthesia in high risk patients. Fentanyl sublingual tablets, transmucosal lozenges, buccal tablets, sublingual sprays, transdermal systems, and nasal sprays are indicated for the management of breakthrough pain in opioid tolerant cancer patients who require around the clock pain management.
Associated Conditions
- Cancer Related Pain (Breakthrough Pain)
- Severe, Chronic Pain
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/06 | Not Applicable | Recruiting | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | ||
2024/08/01 | Phase 2 | Not yet recruiting | |||
2024/07/16 | Phase 1 | Completed | |||
2024/07/12 | Phase 4 | Recruiting | |||
2024/06/28 | Phase 4 | Not yet recruiting | |||
2024/06/18 | Phase 3 | Recruiting | |||
2024/06/18 | Not Applicable | Completed | |||
2024/05/30 | Early Phase 1 | Not yet recruiting | |||
2024/05/16 | Phase 2 | Recruiting | Kasr El Aini Hospital | ||
2024/05/14 | Not Applicable | Completed | Ondokuz Mayıs University |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 0641-6025 | INTRAMUSCULAR, INTRAVENOUS | 50 ug in 1 mL | 3/5/2024 | |
| Renaissance Lakewood LLC | 49396-0512 | NASAL | 2 mg in 1 mL | 3/3/2023 | |
| West Therapeutics Development, LLC | 71500-012 | SUBLINGUAL | 0.6 mg in 1 1 | 4/28/2021 | |
| DirectRX | 61919-602 | TRANSDERMAL | 25 ug in 1 h | 1/20/2020 | |
| SpecGx LLC | 0406-9206 | TRANSMUCOSAL | 600 ug in 1 1 | 10/19/2023 | |
| Apotex Corp. | 60505-7083 | TRANSDERMAL | 75 ug in 1 h | 5/1/2023 | |
| Apotex Corp. | 60505-7082 | TRANSDERMAL | 50 ug in 1 h | 5/1/2023 | |
| Mayne Pharma | 51862-638 | BUCCAL, SUBLINGUAL | 800 ug in 1 1 | 1/31/2024 | |
| Apotex Corp. | 60505-7011 | TRANSDERMAL | 25 ug in 1 h | 7/13/2023 | |
| Civica, Inc. | 72572-172 | INTRAVENOUS | 50 ug in 1 mL | 4/2/2024 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| DURAGESIC | 02275848 | Patch - Transdermal | 75 MCG / HOUR | 5/11/2009 | |
| CO FENTANYL | Cobalt Pharmaceuticals Company | 02386852 | Patch - Transdermal | 25 MCG / HOUR | 10/18/2012 |
| APO-FENTANYL MATRIX | 02314630 | Patch - Transdermal | 25 MCG / HOUR | 5/13/2009 | |
| TEVA-FENTANYL | teva canada limited | 02282968 | Patch - Transdermal | 50 MCG / HOUR | 7/4/2006 |
| TEVA-FENTANYL | teva canada limited | 02311925 | Patch - Transdermal | 12 MCG / HOUR | 6/27/2008 |
| RAN-FENTANYL TRANSDERMAL SYSTEM | ranbaxy pharmaceuticals canada inc. | 02249391 | Patch - Transdermal | 2.5 MG | 7/11/2006 |
| SANDOZ FENTANYL PATCH | 02327112 | Patch - Transdermal | 12 MCG / HOUR | 11/1/2010 | |
| SANDOZ FENTANYL PATCH | 02327155 | Patch - Transdermal | 75 MCG / HOUR | 11/1/2010 | |
| RAN-FENTANYL MATRIX PATCH | ranbaxy pharmaceuticals canada inc. | 02330148 | Patch - Transdermal | 75 MCG / HOUR | 9/28/2009 |
| CO FENTANYL | Cobalt Pharmaceuticals Company | 02386879 | Patch - Transdermal | 50 MCG / HOUR | 10/18/2012 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ABATTRA 12 MICROGRAMOS/HORA PARCHES TRANSDERMICOS EFG | Aristo Pharma Iberia S.L. | 74120 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
| FENDIVIA 12 microgramos/HORA PARCHE TRANSDERMICO | 68518 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized | |
| DUROGESIC MATRIX 50 microgramos/H PARCHES TRANSDERMICOS | Janssen Cilag S.A. | 61960 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
| MATRIFEN 12 microgramos/HORA PARCHE TRANSDERMICO | 68363 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized | |
| FENTANILO MATRIX STADA 75 microgramos/H PARCHES TRANSDERMICOS EFG | Laboratorio Stada S.L. | 71765 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
| DOLOXITAL 50 MICROGRAMOS/HORA PARCHES TRANSDERMICOS EFG | Aristo Pharma Iberia S.L. | 73931 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
| FENDIVIA 75 microgramos/HORA PARCHE TRANSDERMICO | 68495 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized | |
| FENTANILO MATRIX VIATRIS 25 mcg/H PARCHES TRANSDERMICOS EFG | 75952 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized | |
| FENTANILO MATRIX ZENTIVA 75 microgramos/H PARCHES TRANSDERMICOS EFG | 68564 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Not Commercialized | |
| FENTANILO MATRIX NORMON 100 microgramos/H PARCHES TRANSDERMICOS EFG | Laboratorios Normon S.A. | 72740 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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