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 |
|---|---|---|---|---|---|
2022/10/27 | Not Applicable | Completed | |||
2022/09/22 | Not Applicable | Completed | |||
2022/09/16 | Not Applicable | ENROLLING_BY_INVITATION | |||
2022/09/14 | Early Phase 1 | Recruiting | |||
2022/09/08 | Phase 2 | Completed | Lee's Pharmaceutical Limited | ||
2022/09/08 | N/A | Completed | Dr. Mihai Octavian Botea | ||
2022/09/02 | Not Applicable | Completed | Second Affiliated Hospital of Nanchang University | ||
2022/08/22 | Not Applicable | Not yet recruiting | General Hospital of Ningxia Medical University | ||
2022/08/16 | Not Applicable | Recruiting | Kasr El Aini Hospital | ||
2022/08/15 | Not Applicable | Active, not recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 0641-6024 | INTRAMUSCULAR, INTRAVENOUS | 50 ug in 1 mL | 3/5/2024 | |
| Cephalon, LLC | 63459-548 | BUCCAL, SUBLINGUAL | 800 ug in 1 1 | 12/17/2023 | |
| Apotex Corp. | 60505-7081 | TRANSDERMAL | 25 ug in 1 h | 5/1/2023 | |
| Galena Biopharma, Inc. | 57881-338 | SUBLINGUAL | 800 ug in 1 1 | 11/30/2014 | |
| Quality Care Products, LLC | 35356-634 | TRANSDERMAL | 75 ug in 1 h | 10/22/2019 | |
| West Therapeutic Development LLC | 71500-140 | NASAL | 400 ug in 1 1 | 3/31/2021 | |
| Fresenius Kabi USA, LLC | 63323-808 | INTRAVENOUS, INTRAMUSCULAR | 50 ug in 1 mL | 1/31/2023 | |
| Cephalon, LLC | 63459-542 | BUCCAL, SUBLINGUAL | 200 ug in 1 1 | 12/17/2023 | |
| Hikma Pharmaceuticals USA Inc. | 0641-6026 | INTRAVENOUS | 50 ug in 1 mL | 3/5/2024 | |
| Cantrell Drug Company | 52533-080 | EPIDURAL | 2 ug in 1 mL | 1/12/2015 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||