CLINICAL TRIALS PROFILE FOR FENTANYL CITRATE

All Clinical Trials for Fentanyl Citrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003000 ↗	Morphine for the Treatment of Pain in Patients With Breast Cancer	Completed	Roswell Park Cancer Institute		1992-05-01	RATIONALE: Morphine helps to relieve the pain associated with cancer surgery. Giving morphine in different ways may offer more pain relief. PURPOSE: This randomized clinical trial is studying how well morphine injected directly into the underarm area works compared with morphine injected into the back of the shoulder in treating pain in patients who have breast cancer and who are undergoing axillary lymph node dissection.
NCT00105287 ↗	Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients	Completed	Cephalon	Phase 3	2005-01-01	The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.
NCT00105937 ↗	OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients	Completed	Cephalon	Phase 3	2004-04-01	The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.
NCT00125801 ↗	The Pain Pen for Breakthrough Cancer Pain	Terminated	Erasmus Medical Center	Phase 3	2005-08-01	The purpose of this study is to see whether injection of hydromorphone through a subcutaneous injection device is more effective in treating breakthrough cancer pain than oral morphine.
NCT00209534 ↗	A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy	Completed	Bio Analytical Research Corporation	Phase 2	2003-01-01	This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing adequate sedation in patients undergoing colonoscopy. Prior to the procedure, patients received fentanyl citrate for pain management followed five minutes later by AQUAVAN® Injection for sedation. Throughout the procedure, study personnel assessed the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator were asked to complete satisfaction surveys.
NCT00209534 ↗	A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy	Completed	HHI Clinical Research (Biostatistics)	Phase 2	2003-01-01	This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing adequate sedation in patients undergoing colonoscopy. Prior to the procedure, patients received fentanyl citrate for pain management followed five minutes later by AQUAVAN® Injection for sedation. Throughout the procedure, study personnel assessed the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator were asked to complete satisfaction surveys.
NCT00209534 ↗	A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy	Completed	MDS Pharma Services	Phase 2	2003-01-01	This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing adequate sedation in patients undergoing colonoscopy. Prior to the procedure, patients received fentanyl citrate for pain management followed five minutes later by AQUAVAN® Injection for sedation. Throughout the procedure, study personnel assessed the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator were asked to complete satisfaction surveys.

Clinical Trial Conditions for Fentanyl Citrate

Condition Name

Condition Name for Fentanyl Citrate
Intervention	Trials
Pain	23
Cancer	9
Breakthrough Pain	5
Postoperative Pain	5

Condition MeSH

Condition MeSH for Fentanyl Citrate
Intervention	Trials
Breakthrough Pain	16
Pain, Postoperative	10
Cancer Pain	6
Dyspnea	5

Clinical Trial Locations for Fentanyl Citrate

Trials by Country

Trials by Country for Fentanyl Citrate
Location	Trials
United States	199
Canada	9
Egypt	7
India	6
Korea, Republic of	5

Trials by US State

Trials by US State for Fentanyl Citrate
Location	Trials
New York	14
California	12
Texas	11
Florida	10
North Carolina	10

Clinical Trial Progress for Fentanyl Citrate

Clinical Trial Phase

Clinical Trial Phase for Fentanyl Citrate
Clinical Trial Phase	Trials
Phase 4	25
Phase 3	25
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Fentanyl Citrate
Clinical Trial Phase	Trials
Completed	60
Unknown status	12
Terminated	12

Clinical Trial Sponsors for Fentanyl Citrate

Sponsor Name

Sponsor Name for Fentanyl Citrate
Sponsor	Trials
Cephalon	11
Eisai Inc.	8
PPD	5

Sponsor Type

Sponsor Type for Fentanyl Citrate
Sponsor	Trials
Other	86
Industry	54
NIH	3

Fentanyl Citrate: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

Fentanyl citrate, a synthetic opioid analgesic, is widely used for managing severe pain, particularly in cancer patients and those undergoing surgical procedures. This article delves into recent clinical trials, market analysis, and future projections for fentanyl citrate.

Clinical Trials and Efficacy

Nebulized Fentanyl Citrate

A randomized clinical trial compared the pain relief achieved with nebulized fentanyl citrate versus intravenous (i.v.) fentanyl citrate in children presenting to the emergency department with painful conditions. The study found that nebulized fentanyl citrate at a dose of 3.0 microg/kg was a feasible alternative to i.v. fentanyl citrate, showing a significant mean decrease in pain scores. The nebulized group had a mean decrease in pain of 77.8 mm on the visual analog scale (VAS), compared to 55.1 mm for the i.v. group. No adverse events were detected, indicating the safety and efficacy of nebulized fentanyl citrate for acute pain management in children[1].

Combined Oral Fentanyl Citrate and Midazolam

Another clinical trial evaluated the efficacy of combined oral fentanyl citrate and midazolam as premedication for bone marrow aspiration and biopsy in patients with hematological malignancies. This randomized, controlled, and patient-blinded trial showed that the combination provided effective sedation and analgesia, improving patient comfort during these procedures[4].

Market Analysis

Global Market Size and Growth

The global fentanyl market was valued at over USD 17.02 billion in 2024 and is projected to exceed USD 37.54 billion by 2037, growing at a compound annual growth rate (CAGR) of 6.4% during the forecast period of 2025-2037. This growth is driven by the increasing prevalence of cancer worldwide, increased awareness and investment in cancer research, and rising global healthcare spending[2].

End-User Segmentation

The market is segmented by end-users into hospitals, oncology centers, surgical centers, and others. Oncology centers are expected to hold the largest market share, approximately 35% by 2037, due to the specialized cancer treatments they offer and the growing number of cancer patients. Hospitals also play a significant role, with their large patient base and expanding number of facilities[2].

Regional Market Dynamics

The North American region is projected to hold the largest market share, around 35% by 2037, due to factors such as a growing population, extensive research activities, health insurance coverage for cancer diagnoses, and the economic affordability of advanced treatments. The Asia Pacific region is expected to hold the second largest share, driven by the rapidly aging population and government initiatives to raise cancer awareness and improve medical infrastructure[2].

Market Drivers and Challenges

Growth Drivers

• Increasing Prevalence of Cancer: The rising number of cancer cases globally is a significant driver, with over 10 million cancer-related deaths reported in 2020[2].
• Healthcare Spending: Increased global healthcare spending, such as the USD 1,111,082 per capita spent in 2018, is boosting the market[2].
• Awareness and Research: Growing awareness campaigns about the therapeutic effects of fentanyl and increased investment in medical research are also driving market growth[2].

Challenges

• Regulatory Scrutiny: Fentanyl, being a potent opioid, is under strict regulatory scrutiny due to its potential for abuse and overdose.
• Side Effects: Despite its efficacy, fentanyl can have significant side effects, which need careful monitoring and management[3].

New Formulations and Delivery Methods

Orally Disintegrating Tablets

New formulations like orally disintegrating tablets (ODTs) of fentanyl citrate, such as Fentora, have been introduced. These formulations offer immediate release and are designed for breakthrough pain in adult cancer patients. Bioavailability and bioequivalence studies have supported the safety and efficacy of these new formulations[3].

Nebulized Administration

The use of nebulized fentanyl citrate, as mentioned in the clinical trial, provides an alternative delivery method that can be particularly useful in emergency settings or for patients who have difficulty with other administration routes[1].

Key Takeaways

• Clinical Efficacy: Fentanyl citrate has shown efficacy in various clinical trials, including its use in nebulized form and in combination with midazolam.
• Market Growth: The global fentanyl market is expected to grow significantly, driven by the increasing prevalence of cancer and rising healthcare spending.
• Regional Dynamics: North America and the Asia Pacific region are key markets due to their demographic and healthcare infrastructure factors.
• New Formulations: Innovations in delivery methods, such as orally disintegrating tablets and nebulized administration, are expanding the therapeutic options for fentanyl citrate.

FAQs

What is the primary use of fentanyl citrate?

Fentanyl citrate is primarily used for managing severe pain, especially in cancer patients and those undergoing surgical procedures.

What are the key drivers of the fentanyl market growth?

The key drivers include the increasing prevalence of cancer, growing global healthcare spending, and increased awareness and investment in cancer research.

What are the new formulations of fentanyl citrate?

New formulations include orally disintegrating tablets (ODTs) like Fentora and nebulized fentanyl citrate, which offer alternative delivery methods.

Which regions are expected to dominate the fentanyl market?

North America and the Asia Pacific region are projected to hold the largest and second largest market shares, respectively.

What are the potential challenges for the fentanyl market?

Challenges include regulatory scrutiny due to its potential for abuse, side effects, and the need for careful monitoring and management.

Sources

1. Randomized clinical trial of nebulized fentanyl citrate versus i.v. fentanyl citrate in children: PubMed, "Randomized clinical trial of nebulized fentanyl citrate versus i.v. fentanyl citrate in children presenting to the emergency department with painful conditions."
2. Fentanyl Market Size | Growth Analysis 2025-2037: Research Nester, "Fentanyl Market Size | Growth Analysis 2025-2037."
3. Australian public assessment report for Fentanyl citrate (Fentora): TGA, "Australian public assessment report for Fentanyl citrate (Fentora)."
4. Combined Oral Fentanyl Citrate and Midazolam as Premedication: MDPI, "Combined Oral Fentanyl Citrate and Midazolam as Premedication for Bone Marrow Aspiration and Biopsy in Patients with Hematological Malignancies: A Randomized, Controlled and Patient-Blinded Clinical Trial."