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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.

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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FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Galena Biopharma, Inc.
57881-334
SUBLINGUAL
400 ug in 1 1
11/30/2014
Insys Therapeutics, Inc.
20482-008
SUBLINGUAL
0.8 mg in 1 1
5/4/2021
Cantrell Drug Company
52533-080
EPIDURAL
2 ug in 1 mL
8/11/2014
Lake Erie Medical DBA Quality Care Products LLC
55700-597
TRANSDERMAL
25 ug in 1 1
8/15/2022
ALVOGEN
47781-428
TRANSDERMAL
100 ug in 1 1
1/18/2024
West Therapeutics Development, LLC
71500-001
SUBLINGUAL
0.1 mg in 1 1
4/28/2021
Galena Biopharma, Inc.
57881-332
SUBLINGUAL
200 ug in 1 1
11/30/2014
Cephalon, LLC
63459-541
BUCCAL, SUBLINGUAL
100 ug in 1 1
12/17/2023
West Therapeutics Development, LLC
71500-002
SUBLINGUAL
0.2 mg in 1 1
4/28/2021
Physicians Total Care, Inc.
54868-0162
TRANSDERMAL
2.55 mg in 1 [USP'U]
9/17/2010

EMA Drug Approvals

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No EMA approvals found for this drug.

HSA Drug Approvals

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NMPA Drug Approvals

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Approval Number
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Approval Date
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PPB Drug Approvals

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TGA Drug Approvals

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