CLINICAL TRIALS PROFILE FOR FENTANYL-87

505(b)(2) Clinical Trials for FENTANYL-87

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01691690 ↗	Analgesic Effect of IV Acetaminophen in Tonsillectomies	Completed	Nationwide Children's Hospital	Phase 2	2012-10-01	Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	Pacira Pharmaceuticals, Inc	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	University of California, San Diego	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Combination	NCT00620828 ↗	The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty	Completed	Pfizer	Phase 4	2007-05-01	The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
New Combination	NCT00620828 ↗	The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty	Completed	Duke University	Phase 4	2007-05-01	The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.

All Clinical Trials for FENTANYL-87

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004424 ↗	Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy	Completed	Case Western Reserve University	N/A	1996-07-01	OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
NCT00004424 ↗	Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy	Completed	FDA Office of Orphan Products Development	N/A	1996-07-01	OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
NCT00000273 ↗	A Laboratory Model for Heroin Abuse Medications - 8	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1995-08-01	The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
NCT00000273 ↗	A Laboratory Model for Heroin Abuse Medications - 8	Completed	New York State Psychiatric Institute	Phase 2	1995-08-01	The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
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.

Clinical Trial Conditions for FENTANYL-87

Condition Name

Condition Name for FENTANYL-87
Intervention	Trials
Pain	161
Postoperative Pain	107
Pain, Postoperative	92
Anesthesia	85

Condition MeSH

Condition MeSH for FENTANYL-87
Intervention	Trials
Pain, Postoperative	247
Acute Pain	56
Vomiting	46
Breakthrough Pain	43

Clinical Trial Locations for FENTANYL-87

Trials by Country

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−

Trials by Country for FENTANYL-87
Location	Trials
United States	865
Egypt	270
Canada	99
China	81
Korea, Republic of	71

Trials by US State

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Trials by US State for FENTANYL-87
Location	Trials
California	77
New York	63
Texas	62
North Carolina	50
Illinois	44

Clinical Trial Progress for FENTANYL-87

Clinical Trial Phase

Clinical Trial Phase for FENTANYL-87
Clinical Trial Phase	Trials
Phase 4	564
Phase 3	200
Phase 2/Phase 3	51

Clinical Trial Status

Clinical Trial Status for FENTANYL-87
Clinical Trial Phase	Trials
Completed	890
Recruiting	230
Unknown status	195

Clinical Trial Sponsors for FENTANYL-87

Sponsor Name

Sponsor Name for FENTANYL-87
Sponsor	Trials
Cairo University	47
Ain Shams University	40
Mansoura University	38

Sponsor Type

Sponsor Type for FENTANYL-87
Sponsor	Trials
Other	1765
Industry	254
U.S. Fed	33

Fentanyl: Clinical Trials, Market Analysis, and Projections

Introduction

Fentanyl, a potent synthetic opioid, has been at the forefront of both medical and illicit drug landscapes. This article delves into recent clinical trials, market analysis, and projections for fentanyl, highlighting its medical uses, illicit market dynamics, and public health implications.

Clinical Trials Update

Efficacy of Buprenorphine Formulations for OUD

A recent clinical trial compared the efficacy of extended-release subcutaneous buprenorphine (SC-BPN) versus sublingual buprenorphine-naloxone (BPN-NX) in treating opioid use disorder (OUD), particularly among patients with fentanyl use[1].

• Key Findings: The trial, conducted over 24 weeks, showed that SC-BPN was more effective in reducing fentanyl use. Patients receiving SC-BPN had a higher percentage of urine samples negative for fentanyl (74.6% vs 61.9% for BPN-NX) and opioids (36.7% vs 30.6% for BPN-NX) compared to those receiving BPN-NX.
• Implications: These results suggest that the subcutaneous formulation of buprenorphine may offer an advantage in treating OUD, especially in cases involving fentanyl.

Market Analysis

Illicit Fentanyl Market

The illicit market for fentanyl is complex and highly lucrative, driven by its potency and ease of distribution.

• Darknet Markets: Fentanyl and its analogues are widely available on darknet markets. Despite bans, such as Dream Market's ban in 2018, fentanyl continues to be listed and sold. The efficiency and anonymity of these markets make regulation challenging[2].
• Global Supply Chain: Precursor chemicals for fentanyl are often diverted or clandestinely manufactured in countries like China and India, then shipped to North America via Mexico. Chinese and South American crime groups dominate this supply chain[2].
• Economic Impact: The illicit fentanyl market is highly profitable. For example, 10 grams of fentanyl can produce the equivalent of one kilogram of synthetic heroin, valued at between A$160,000 and A$195,000 in the Australian market[2].

Prescription Fentanyl Market

On the legitimate side, fentanyl is used as a potent analgesic for severe pain, particularly in cancer patients.

• Regulatory Efforts: The FDA has implemented several measures to ensure the safe use of fentanyl and other opioids. This includes the development of Risk Evaluation and Mitigation Strategies (REMS) programs, which require manufacturers to provide training for prescribers and ensure safe use practices[3].
• Product Approvals: Several fentanyl products have been approved with REMS programs in place, such as Abstral, Lazanda, and Subsys. These products are designed to mitigate the risk of abuse and overdose[3].

Public Health Implications

Overdose Deaths

The presence of fentanyl and its analogues in the drug supply has significant public health implications.

• Overdose Trends: According to CDC data, approximately 72,000 drug overdose deaths in the U.S. in 2023 involved illegally manufactured fentanyls (IMFs). The percentage of overdose deaths with IMFs detected remained stable at 70-80% in most regions, but increased in the West[4].
• Carfentanil Emergence: Carfentanil, a fentanyl analogue 100 times more potent than fentanyl, has seen a significant increase in detection in overdose deaths. This trend highlights the need for adaptable overdose prevention strategies[4].

Prevention Efforts

To address the opioid crisis, public health efforts are focusing on several key areas.

• Naloxone Availability: The FDA has supported initiatives to make naloxone, an opioid overdose reversal drug, more widely available. This includes community distribution programs and training for healthcare providers[3].
• Prescription Monitoring: State prescription drug monitoring programs (PDMPs) are being enhanced to track and reduce the misuse of opioids. These programs help identify high-volume prescribers and educate them on safer prescribing practices[3].

Market Projections

Illicit Market

The illicit fentanyl market is expected to remain a significant challenge due to its profitability and the adaptability of criminal organizations.

• Continued Availability: Despite regulatory efforts, fentanyl is likely to remain widely available on darknet markets and through other illicit channels. The anonymity and efficiency of these markets make them difficult to regulate[2].
• Emergence of New Analogues: The reemergence of carfentanil and other potent fentanyl analogues suggests that the illicit market will continue to evolve, posing ongoing risks to public health[4].

Prescription Market

The legitimate market for fentanyl is expected to be shaped by ongoing regulatory efforts and the development of new formulations.

• Abuse-Deterrent Formulations: The FDA's focus on abuse-deterrent formulations is likely to influence the development of new opioid products. This could lead to safer prescribing practices and reduced misuse[3].
• Expanded REMS Programs: The expansion of REMS programs to cover more opioid products will continue to be a key strategy in managing the opioid crisis. These programs aim to ensure that prescribers are adequately trained and that patients are monitored closely[3].

Key Takeaways

• Clinical Efficacy: Extended-release subcutaneous buprenorphine shows promise in treating OUD, especially among patients with fentanyl use.
• Illicit Market Dynamics: Fentanyl remains a lucrative and dangerous component of the illicit drug market, with ongoing challenges in regulation.
• Public Health Implications: The presence of fentanyl and its analogues continues to drive high overdose death rates, necessitating adaptable prevention strategies.
• Regulatory Efforts: The FDA's initiatives, including REMS programs and abuse-deterrent formulations, aim to mitigate the risks associated with opioid use.

FAQs

What is the current status of fentanyl in clinical trials for OUD?

Clinical trials suggest that extended-release subcutaneous buprenorphine is effective in treating OUD, particularly among patients with fentanyl use, showing higher rates of opioid-negative urine samples compared to sublingual buprenorphine-naloxone[1].

How widespread is fentanyl on darknet markets?

Fentanyl is widely available on darknet markets, despite bans and regulatory efforts. These markets continue to be a significant avenue for the distribution of synthetic opioids[2].

What are the public health implications of fentanyl and its analogues?

The presence of fentanyl and its analogues, such as carfentanil, in the drug supply has led to a high number of overdose deaths. Public health efforts focus on making naloxone more available and adapting prevention strategies to address the evolving opioid crisis[4].

What regulatory measures are in place for prescription fentanyl?

The FDA has implemented REMS programs for fentanyl products to ensure safe use practices. These programs include training for prescribers and monitoring of patients to reduce the risk of abuse and overdose[3].

How is the emergence of carfentanil impacting public health?

The reemergence of carfentanil has led to a significant increase in overdose deaths. This trend underscores the need for adaptable prevention strategies that can address the presence of potent opioids in the drug supply[4].

Sources

1. Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder: A Randomized Clinical Trial. JAMA Network Open.
2. Fentanyl availability on darknet markets. Australian Institute of Criminology.
3. Overdose Prevention Activities Timeline - FDA. U.S. Food and Drug Administration.
4. Detection of Illegally Manufactured Fentanyls and Carfentanil in Drug Overdose Deaths — United States, January 2021–June 2024. Centers for Disease Control and Prevention.