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.
Background
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 |
|---|---|---|---|---|---|
2025/02/19 | Not Applicable | Recruiting | |||
2025/02/19 | Phase 1 | Completed | |||
2025/02/12 | Phase 4 | Recruiting | Jehan George Sadek | ||
2025/02/11 | Not Applicable | Recruiting | |||
2025/01/29 | Phase 2 | Not yet recruiting | |||
2025/01/20 | Phase 4 | Recruiting | |||
2025/01/13 | Phase 4 | Recruiting | |||
2025/01/08 | Phase 4 | Not yet recruiting | Qassim Health Cluster | ||
2024/12/09 | Phase 4 | Not yet recruiting | |||
2024/12/06 | Phase 4 | Not yet recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Insys Therapeutics, Inc. | 20482-006 | SUBLINGUAL | 0.6 mg in 1 1 | 5/4/2021 | |
| Civica, Inc. | 72572-171 | INTRAMUSCULAR, INTRAVENOUS | 50 ug in 1 mL | 4/2/2024 | |
| Cantrell Drug Company | 52533-025 | INTRAVENOUS | 20 ug in 1 mL | 8/13/2014 | |
| Hospira, Inc. | 0409-9093 | INTRAVENOUS, INTRAMUSCULAR | 50 ug in 1 mL | 12/11/2019 | |
| Cantrell Drug Company | 52533-025 | INTRAVENOUS | 20 ug in 1 mL | 1/30/2013 | |
| Cephalon, LLC | 63459-506 | ORAL, TRANSMUCOSAL | 600 ug in 1 1 | 12/18/2023 | |
| ALVOGEN | 47781-427 | TRANSDERMAL | 75 ug in 1 1 | 1/18/2024 | |
| Lake Erie Medical DBA Quality Care Products LLC | 35356-635 | TRANSDERMAL | 100 ug in 1 h | 10/22/2019 | |
| Dispensing Solutions Inc. | 68258-3025 | TRANSDERMAL | 100 ug in 1 h | 3/3/2010 | |
| Quality Care Products, LLC | 55700-753 | TRANSDERMAL | 25 ug in 1 h | 7/13/2023 |
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 |
|---|---|---|---|---|---|
| DBL FENTANYL INJECTION 50 mcg/ml | SIN00754P | INJECTION | 50mcg/mL | 5/4/1988 | |
| FENTANYL INJECTION 0.1 mg/2 ml | SIN01113P | INJECTION | 0.1 mg/2 ml | 5/12/1988 | |
| FANTAMAX TTS MATRIX 50μg/h | SIN13621P | PATCH | 11.56 mg/21 sq cm | 3/19/2009 | |
| FENTANYL KALCEKS SOLUTION FOR INJECTION 0.05 MG/ML | SIN15802P | INJECTION, SOLUTION | 0.05 mg/ml | 9/10/2019 | |
| ABSTRAL SUBLINGUAL TABLET 400 mcg | SIN15150P | TABLET | 400 µg | 1/6/2017 | |
| DUROGESIC TRANSDERMAL SYSTEM 25 mcg/hr | SIN08334P | PATCH | 4.2 mg | 7/29/1995 | |
| ABSTRAL SUBLINGUAL TABLET 100 mcg | SIN15147P | TABLET | 100 µg | 1/6/2017 | |
| Fentanyl 50 micrograms/ml Solution for Injection | SIN10358P | INJECTION | 50 mcg/ml | 11/4/1998 | |
| DUROGESIC TRANSDERMAL SYSTEM 75 mcg/hr | SIN08332P | PATCH | 12.6 mg | 7/29/1995 | |
| MARTINDALE PHARMA FENTANYL SOLUTION FOR INJECTION 50MCG/ML | SIN15688P | INJECTION, SOLUTION | 50MCG | 5/16/2019 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Fentanyl Transdermal Patches | 国药准字HJ20150593 | 化学药品 | 贴剂 | 9/17/2020 | |
| Fentanyl Transdermal Patches | 国药准字HJ20150596 | 化学药品 | 贴剂 | 9/17/2020 | |
| Fentanyl Transdermal Patches | 国药准字H20123327 | 化学药品 | 贴剂 | 2/24/2022 | |
| Fentanyl Transdermal Patches | 国药准字HJ20150592 | 化学药品 | 贴剂 | 9/17/2020 | |
| Fentanyl Transdermal Patches | 国药准字H20163277 | 化学药品 | 贴剂 | 2/24/2022 | |
| Fentanyl Transdermal Patches | 国药准字H20163127 | 化学药品 | 贴剂 | 2/24/2022 | |
| Fentanyl Transdermal Patches | 国药准字H20163279 | 化学药品 | 贴剂 | 2/24/2022 | |
| Fentanyl Transdermal Patches | 国药准字HJ20150591 | 化学药品 | 贴剂 | 9/17/2020 | |
| Fentanyl Transdermal Patches | 国药准字H20057055 | 化学药品 | 贴剂 | 7/22/2020 |
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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