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
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

A 15-day Study to Assess the Safety and Clinical Utility of Duragesic (Fentanyl Transdermal Patch) in the Treatment of Children With Continuous Pain Requiring Narcotic Pain Relief Therapy

Phase 3
Completed
Conditions
Chronic Pain
First Posted Date
2006-01-02
Last Posted Date
2011-05-17
Lead Sponsor
Janssen Pharmaceutica N.V., Belgium
Target Recruit Count
53
Registration Number
NCT00271414

Clinical Use and Safety of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer

Phase 3
Completed
Conditions
Pain
Cancer
First Posted Date
2005-12-26
Last Posted Date
2011-05-19
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
32
Registration Number
NCT00269763

Efficacy of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer

Phase 3
Completed
Conditions
Pain
Cancer
First Posted Date
2005-12-26
Last Posted Date
2011-05-19
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
7
Registration Number
NCT00269737

Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients

Phase 3
Completed
Conditions
Pain
Cancer
Interventions
First Posted Date
2005-12-09
Last Posted Date
2024-06-18
Lead Sponsor
Kyowa Kirin Co., Ltd.
Target Recruit Count
139
Registration Number
NCT00263575
Locations
🇺🇸

Carolinas Pain Institute, Winston-Salem, North Carolina, United States

Efficacy and Safety of Sublingual Fentanyl Tablets in Treatment of Breakthrough Pain in Cancer Patients.

Phase 3
Completed
Conditions
Pain
Cancer
First Posted Date
2005-12-07
Last Posted Date
2009-06-04
Lead Sponsor
Kyowa Kirin Co., Ltd.
Registration Number
NCT00262678
Locations
🇺🇸

Carolinas Pain Institute, Winston-Salem, North Carolina, United States

Postoperative Pain After Orthopedic Surgery: Does it Help to Give Fentanyl Before Start of Remifentanil Based Anesthesia?

Phase 3
Completed
Conditions
Pain, Postoperative
First Posted Date
2005-10-18
Last Posted Date
2011-07-06
Lead Sponsor
Ullevaal University Hospital
Target Recruit Count
100
Registration Number
NCT00241332
Locations
🇳🇴

Ullevaal University Hospital, Oslo, Norway

Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain

Phase 2
Completed
Conditions
Pain
Cancer
Sickle Cell Anemia
Severe Burns
First Posted Date
2005-10-12
Last Posted Date
2014-05-09
Lead Sponsor
Cephalon
Registration Number
NCT00236093
Locations
🇺🇸

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States

🇺🇸

Childrens National Medical Center, Washington, District of Columbia, United States

🇺🇸

Sacred Heart Medical Center, Spokane, Washington, United States

and more 25 locations

Evaluate the Efficacy and Safety of ACTIQ in Patients With Cancer and Breakthrough Pain

Phase 3
Completed
Conditions
Breakthrough Pain
First Posted Date
2005-10-12
Last Posted Date
2013-01-29
Lead Sponsor
Cephalon
Registration Number
NCT00236145

Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)

Phase 2
Completed
Conditions
Cancer
Breakthrough Pain
First Posted Date
2005-10-12
Last Posted Date
2014-05-09
Lead Sponsor
Cephalon
Target Recruit Count
38
Registration Number
NCT00236041
Locations
🇺🇸

Tod Children's Hospital, Youngstown, Ohio, United States

🇺🇸

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States

🇺🇸

Scottish Rite Children's Medical Center, Atlanta, Georgia, United States

and more 28 locations

Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain

Phase 4
Completed
Conditions
Low Back Pain
First Posted Date
2005-10-12
Last Posted Date
2013-11-20
Lead Sponsor
PriCara, Unit of Ortho-McNeil, Inc.
Target Recruit Count
358
Registration Number
NCT00237341
© Copyright 2025. All Rights Reserved by MedPath