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 |
|---|---|---|---|---|---|
2023/08/30 | Phase 2 | Recruiting | |||
2023/08/21 | Not Applicable | Recruiting | |||
2023/08/14 | N/A | Recruiting | |||
2023/08/14 | N/A | Completed | Burak Omur | ||
2023/08/08 | Phase 4 | Recruiting | Hospital for Special Surgery, New York | ||
2023/07/24 | Not Applicable | Completed | |||
2023/06/15 | Phase 4 | Recruiting | Pouya Azar | ||
2023/05/17 | Not Applicable | Completed | Chung-Ang University Gwangmyeong Hospital | ||
2023/05/12 | Phase 4 | Active, not recruiting | |||
2023/05/09 | Not Applicable | Not yet recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Galena Biopharma, Inc. | 57881-334 | SUBLINGUAL | 400 ug in 1 1 | 11/30/2014 | |
| Insys Therapeutics, Inc. | 20482-008 | SUBLINGUAL | 0.8 mg in 1 1 | 5/4/2021 | |
| Cantrell Drug Company | 52533-080 | EPIDURAL | 2 ug in 1 mL | 8/11/2014 | |
| Lake Erie Medical DBA Quality Care Products LLC | 55700-597 | TRANSDERMAL | 25 ug in 1 1 | 8/15/2022 | |
| ALVOGEN | 47781-428 | TRANSDERMAL | 100 ug in 1 1 | 1/18/2024 | |
| West Therapeutics Development, LLC | 71500-001 | SUBLINGUAL | 0.1 mg in 1 1 | 4/28/2021 | |
| Galena Biopharma, Inc. | 57881-332 | SUBLINGUAL | 200 ug in 1 1 | 11/30/2014 | |
| Cephalon, LLC | 63459-541 | BUCCAL, SUBLINGUAL | 100 ug in 1 1 | 12/17/2023 | |
| West Therapeutics Development, LLC | 71500-002 | SUBLINGUAL | 0.2 mg in 1 1 | 4/28/2021 | |
| Physicians Total Care, Inc. | 54868-0162 | TRANSDERMAL | 2.55 mg in 1 [USP'U] | 9/17/2010 |
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| MATRIFEN 50 microgramos/HORA PARCHE TRANSDERMICO | 68365 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized | |
| DOLOXITAL 75 MICROGRAMOS/HORA PARCHES TRANSDERMICOS EFG | Aristo Pharma Iberia S.L. | 73932 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
| ACTIQ 400 microgramos, COMPRIMIDOS PARA CHUPAR CON APLICADOR BUCAL INTEGRADO | 64057 | COMPRIMIDO PARA CHUPAR | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized | |
| FENTANILO MATRIX RATIOPHARM 12 microgramos/HORA PARCHES TRANSDERMICOS EFG | Teva Pharma S.L.U. | 70041 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
| ACTIQ 600 microgramos, COMPRIMIDOS PARA CHUPAR CON APLICADOR BUCAL INTEGRADO | 64058 | COMPRIMIDO PARA CHUPAR | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
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| No Philippines FDA approvals found for this drug. | |||||
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| No UK EMC drug information found for this drug. | |||||
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