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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
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
Associated Therapies
Anesthetic premedication therapy, Anesthetics Agent, General Anesthesia, Induction of anesthesia therapy, Maintenance of anesthesia therapy, Regional Anesthesia therapy

Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects

Phase 2
Completed
Conditions
Intubated and Mechanically Ventilated Pediatric Subjects
Interventions
First Posted Date
2008-04-03
Last Posted Date
2017-04-13
Lead Sponsor
Hospira, now a wholly owned subsidiary of Pfizer
Target Recruit Count
69
Registration Number
NCT00652028
Locations
🇺🇸

Women and Children's Hospital of Buffalo, Buffalo, New York, United States

🇺🇸

Miami Children's Hospital, Miami, Florida, United States

🇺🇸

University Hospitals Medical Center, Cleveland, Ohio, United States

and more 6 locations

Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr

Phase 1
Terminated
Conditions
Healthy
Interventions
Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 1
Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 2
Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 3
First Posted Date
2008-04-01
Last Posted Date
2024-04-23
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
12
Registration Number
NCT00648414
Locations
🇺🇸

Kendle International Inc., Morgantown, West Virginia, United States

Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M)
Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M)
First Posted Date
2008-04-01
Last Posted Date
2024-04-23
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
12
Registration Number
NCT00650117
Locations
🇺🇸

Kendle International Inc., Morgantown, West Virginia, United States

Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System

First Posted Date
2008-04-01
Last Posted Date
2024-04-23
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
120
Registration Number
NCT00647842
Locations
🇺🇸

Kendle International Inc., Morgantown, West Virginia, United States

Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System With Askina Derm Overlay

First Posted Date
2008-04-01
Last Posted Date
2024-04-23
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
80
Registration Number
NCT00647686
Locations
🇺🇸

Kendle International Inc., Morgantown, West Virginia, United States

Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain

Phase 3
Completed
Conditions
Pain
Interventions
First Posted Date
2008-03-31
Last Posted Date
2012-09-14
Lead Sponsor
University of Aarhus
Target Recruit Count
22
Registration Number
NCT00647127
Locations
🇩🇰

Mech Sense, Department of Gastroenterology, Aalborg, Region Nordjyllan, Denmark

An Efficacy and Safety Study of Fentanyl (JNS020QD) in Participants With Cancer Pain

Phase 3
Completed
Conditions
Pain
Cancer
Interventions
First Posted Date
2008-03-24
Last Posted Date
2013-06-07
Lead Sponsor
Janssen Pharmaceutical K.K.
Target Recruit Count
66
Registration Number
NCT00641667

Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

Not Applicable
Completed
Conditions
Fentanyl Analgesia
Interventions
First Posted Date
2008-03-14
Last Posted Date
2008-03-14
Lead Sponsor
Federal University of São Paulo
Target Recruit Count
30
Registration Number
NCT00635986

Efficacy and Safety Study of Nasalfent for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids

Phase 3
Completed
Conditions
Cancers, Pain
Interventions
Drug: Immediate release morphine sulphate
First Posted Date
2008-01-10
Last Posted Date
2010-01-22
Lead Sponsor
Archimedes Development Ltd
Target Recruit Count
135
Registration Number
NCT00589823
Locations
🇬🇧

Prof Fallon, Edinburgh, United Kingdom

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