MedPath

Fentanyl

Generic Name
Fentanyl
Brand Names
Abstral, Actiq, Duragesic, Effentora, Fentora, Instanyl, Lazanda, Sublimaze, Subsys, PecFent
Drug Type
Small Molecule
Chemical Formula
C22H28N2O
CAS Number
437-38-7
Unique Ingredient Identifier
UF599785JZ

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

HSA Drug Approvals

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.
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