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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/27 | Not Applicable | Recruiting | CAMC Health System | ||
2025/06/25 | Phase 4 | Completed | Nashwa Ahmed | ||
2025/05/29 | Not Applicable | Completed | |||
2025/05/13 | N/A | Recruiting | |||
2025/05/01 | Phase 1 | Not yet recruiting | Lee's Pharmaceutical Limited | ||
2025/04/30 | Phase 1 | Completed | |||
2025/04/02 | Not Applicable | Completed | |||
2025/03/27 | Not Applicable | ENROLLING_BY_INVITATION | |||
2025/03/11 | Phase 4 | Recruiting | |||
2025/03/10 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Cephalon, LLC | 63459-546 | BUCCAL, SUBLINGUAL | 600 ug in 1 1 | 12/17/2023 | |
Mylan Pharmaceuticals Inc. | 0378-9127 | TRANSDERMAL | 87.5 ug in 1 h | 4/13/2023 | |
Cantrell Drug Company | 52533-174 | EPIDURAL | 1 ug in 1 mL | 1/13/2015 | |
SpecGx LLC | 0406-9204 | TRANSMUCOSAL | 400 ug in 1 1 | 10/19/2023 | |
ProStrakan, Inc. | 42747-228 | SUBLINGUAL | 800 ug in 1 1 | 1/21/2011 | |
Hikma Pharmaceuticals USA Inc. | 0641-6249 | INTRAMUSCULAR, INTRAVENOUS | 50 ug in 1 mL | 3/5/2024 | |
Quality Care Products, LLC | 55700-749 | TRANSDERMAL | 12 ug in 1 h | 7/13/2023 | |
Fresenius Kabi USA, LLC | 63323-810 | INTRAVENOUS, INTRAMUSCULAR | 100 ug in 2 mL | 1/31/2023 | |
Mayne Pharma | 51862-637 | BUCCAL, SUBLINGUAL | 600 ug in 1 1 | 1/31/2024 | |
Exela Pharma Sciences, LLC | 51754-2150 | INTRAVENOUS | 50 ug in 1 mL | 12/18/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 8/31/2010 | ||
Authorised | 7/20/2009 | ||
Authorised | 4/4/2008 | ||
Authorised | 7/20/2009 | ||
Authorised | 4/4/2008 | ||
Authorised | 8/31/2010 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
DUROGESIC TRANSDERMAL SYSTEM 50 mcg/hr | SIN08335P | PATCH | 8.4 mg | 7/29/1995 | |
ABSTRAL SUBLINGUAL TABLET 200 mcg | SIN15148P | TABLET | 200 µg | 1/6/2017 | |
Fentanyl-hameln Injection 50 mcg/ml | SIN13542P | INJECTION, SOLUTION | 0.05mg/ml | 8/28/2008 | |
PECFENT NASAL SPRAY SOLUTION 100 MCG/SPRAY | SIN16026P | SPRAY, METERED | 100 μg/spray | 10/12/2020 | |
Durogesic Transdermal System 12mcg/hr | SIN13153P | PATCH | 2.1 mg | 11/2/2005 | |
ABSTRAL SUBLINGUAL TABLET 800 mcg | SIN15152P | TABLET | 800 µg | 1/6/2017 | |
FANTAMAX TTS MATRIX 12μg/h | SIN13949P | PATCH | 2.89 mg | 4/19/2011 | |
FANTAMAX TTS MATRIX 25μg/h | SIN13620P | PATCH | 5.78 mg/10.5 sq cm | 3/19/2009 | |
ABSTRAL SUBLINGUAL TABLET 300 mcg | SIN15149P | TABLET | 300 µg | 1/6/2017 | |
PECFENT NASAL SPRAY SOLUTION 400 MCG/SPRAY | SIN16027P | SPRAY, METERED | 400 μg/spray | 10/12/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Fentanyl Citrate Injection | 国药准字H20123298 | 化学药品 | 注射剂 | 6/17/2022 | |
Fentanyl Citrate Injection | 国药准字H42022076 | 化学药品 | 注射剂 | 6/10/2020 | |
Fentanyl Citrate Injection | 国药准字H20123297 | 化学药品 | 注射剂 | 6/17/2022 | |
Fentanyl Citrate Injection | 国药准字H20113509 | 化学药品 | 注射剂 | 9/9/2021 | |
Fentanyl Citrate Injection | 国药准字H20003688 | 化学药品 | 注射剂 | 6/10/2020 | |
Fentanyl Citrate Injection | 国药准字H20113508 | 化学药品 | 注射剂 | 9/9/2021 | |
Fentanyl Transdermal Patches | 国药准字H20057054 | 化学药品 | 贴剂 | 7/22/2020 | |
Fentanyl Transdermal Patches | 国药准字HJ20150595 | 化学药品 | 贴剂 | 9/17/2020 | |
Fentanyl Transdermal Patches | 国药准字H20163278 | 化学药品 | 贴剂 | 2/24/2022 | |
Fentanyl Transdermal Patches | 国药准字HJ20150594 | 化学药品 | 贴剂 | 9/17/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |