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 |
|---|---|---|---|---|---|
2024/08/19 | Phase 4 | Completed | Ismail Tekin | ||
2024/08/16 | Phase 4 | Completed | |||
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 | Recruiting | |||
2024/05/30 | Early Phase 1 | Not yet recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Apotex Corp. | 60505-7017 | TRANSDERMAL | 87.5 ug in 1 h | 7/13/2023 | |
| Hikma Pharmaceuticals USA Inc. | 0641-6028 | INTRAMUSCULAR, INTRAVENOUS | 50 ug in 1 mL | 3/5/2024 | |
| Bryant Ranch Prepack | 63629-4976 | TRANSDERMAL | 75 ug in 1 h | 7/13/2023 | |
| SpecGx LLC | 0406-9202 | TRANSMUCOSAL | 200 ug in 1 1 | 10/19/2023 | |
| West Therapeutic Development LLC | 71500-110 | NASAL | 100 ug in 1 1 | 3/31/2021 | |
| Insys Therapeutics, Inc. | 20482-004 | SUBLINGUAL | 0.4 mg in 1 1 | 5/4/2021 | |
| Cephalon, LLC | 63459-544 | BUCCAL, SUBLINGUAL | 400 ug in 1 1 | 12/17/2023 | |
| H.J. Harkins Company, Inc. | 52959-566 | ORAL, TRANSMUCOSAL | 1200 1 in 1 1 | 9/6/2011 | |
| Mayne Pharma | 51862-635 | BUCCAL, SUBLINGUAL | 200 ug in 1 1 | 1/31/2024 | |
| Exela Pharma Sciences, LLC | 51754-2160 | INTRAVENOUS | 50 ug in 1 mL | 12/18/2023 |
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 |
|---|---|---|---|---|---|
| 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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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DENPAX fentanyl 12 micrograms/hour transdermal patch | 163066 | Medicine | A | 12/7/2010 | |
| MARCAIN 0.125% WITH FENTANYL 1000 microgram/200mL | 72870 | Medicine | A | 5/3/2000 | |
| SUBLIMAZE fentanyl 500 microgram/10mL (as citrate) injection ampoule | 48264 | Medicine | A | 3/7/1994 | |
| ASPEN FENTANYL fentanyl (as citrate) 500 microgram/10 mL solution for injection | 170931 | Medicine | A | 8/3/2011 | |
| DUROGESIC fentanyl 25 micrograms/h transdermal patch sachet | 112368 | Medicine | A | 11/23/2005 | |
| ASPEN FENTANYL fentanyl (as citrate) 250 microgram/5 mL solution for injection | 170930 | Medicine | A | 8/3/2011 | |
| DENPAX fentanyl 100 micrograms/hour transdermal patch | 163067 | Medicine | A | 12/7/2010 | |
| FENTANYL SANDOZ fentanyl 12 micrograms/hour transdermal drug delivery system sachet | 152572 | Medicine | A | 12/22/2009 | |
| FENTANYL JUNO fentanyl (as citrate) 100 microgram/2 mL injection ampoule | 384587 | Medicine | A | 10/11/2022 | |
| FENTANYL MEDICIANZ fentanyl (as citrate) 500 microgram/10 mL injection ampoule | 401505 | Medicine | A | 11/10/2023 |
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