CLINICAL TRIALS PROFILE FOR FENTANYL-37

505(b)(2) Clinical Trials for FENTANYL-37

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
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 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-37

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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-37

Condition Name

Condition Name for FENTANYL-37
Intervention	Trials
Pain	161
Postoperative Pain	107
Pain, Postoperative	92

Condition MeSH

Condition MeSH for FENTANYL-37
Intervention	Trials
Pain, Postoperative	247
Acute Pain	56
Vomiting	46

Clinical Trial Locations for FENTANYL-37

Trials by Country

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−

Trials by Country for FENTANYL-37
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-37
Location	Trials
California	77
New York	63
Texas	62
North Carolina	50
Illinois	44

Clinical Trial Progress for FENTANYL-37

Clinical Trial Phase

Clinical Trial Phase for FENTANYL-37
Clinical Trial Phase	Trials
Phase 4	564
Phase 3	200
Phase 2/Phase 3	51

Clinical Trial Status

Clinical Trial Status for FENTANYL-37
Clinical Trial Phase	Trials
Completed	890
Recruiting	230
Unknown status	195

Clinical Trial Sponsors for FENTANYL-37

Sponsor Name

Sponsor Name for FENTANYL-37
Sponsor	Trials
Cairo University	47
Ain Shams University	40
Mansoura University	38

Sponsor Type

Sponsor Type for FENTANYL-37
Sponsor	Trials
Other	1765
Industry	254
U.S. Fed	33

Understanding Fentanyl: Clinical Trials, Market Analysis, and Projections

Introduction

Fentanyl, a synthetic opioid, has been at the forefront of public health concerns due to its high potency and widespread misuse. This article delves into recent clinical trials, market analysis, and projections related to fentanyl, providing a comprehensive overview of its impact and future implications.

Clinical Trials: Naloxone Dosing Strategies for Fentanyl Overdose

Recent clinical trials have focused on optimizing naloxone dosing strategies to counteract fentanyl overdoses. A randomized clinical trial conducted in 2021 at Spaulding Clinical Research in Wisconsin compared different intranasal naloxone repeat dosing strategies to determine their effectiveness in rescuing patients from fentanyl overdoses[1].

Key Findings

• The trial involved healthy participants and compared the pharmacokinetics of intranasal naloxone between different repeat dosing strategies.
• The results showed that administering one dose of naloxone at 0, 2.5, 5, and 7.5 minutes significantly increased naloxone plasma concentration at 10 minutes compared to a single dose at 0 and 2.5 minutes.
• Additionally, administering two doses at 0 and 2.5 minutes significantly increased naloxone plasma concentration at 4.5 minutes.
• The study used a validated physiologic pharmacokinetic-pharmacodynamic model to estimate the effect of naloxone dosing strategies on fentanyl and carfentanil overdoses.

Implications

These findings suggest that tailored naloxone dosing strategies can be more effective in managing fentanyl overdoses. However, additional research is needed to determine the optimal dosing in community settings.

Market Analysis: Fentanyl Availability and Distribution

Darknet Markets

Fentanyl is widely available on darknet markets, which are e-commerce platforms that operate anonymously on the dark web. A study by the Australian Institute of Criminology revealed that fentanyl vendors on these markets often offer worldwide shipping, including to regions like Australia[2].

Key Statistics

• Over 27 kilograms of fentanyl products were available on these markets during the observation period.
• The potency of fentanyl amplifies its impact; for example, 10 grams of fentanyl can produce the equivalent of one kilogram of synthetic heroin, valued highly in the illicit market.
• Chinese and South American crime groups dominate the supply of these illicit products, adapting to the opportunities offered by darknet markets.

Regional Trends

The availability and impact of fentanyl vary by region. In the United States, for instance:

CDC Report

A CDC report highlighted that approximately 72,000 drug overdose deaths in the U.S. in 2023 involved illegally manufactured fentanyls (IMFs), with a steady percentage of deaths involving IMFs across most regions except the West, where the percentage increased significantly[4].

Carfentanil Emergence

Carfentanil, a fentanyl analog 100 times more potent than fentanyl, has seen a significant increase in detection in overdose deaths, with a sevenfold increase from January-June 2023 to January-June 2024.

Projections and Public Health Implications

Overdose Prevention Efforts

Given the widespread presence of IMFs, including carfentanil, public health efforts need to be adaptive and robust. The CDC suggests that overdose prevention strategies that can quickly respond to changes in the drug supply could lead to lasting reductions in overdose deaths[4].

Decriminalization and Overdose Rates

A cohort study in Oregon examined the association between drug decriminalization and fatal overdose rates. While initial analyses suggested a positive association between decriminalization and overdose rates, adjusting for the spread of fentanyl in the unregulated drug market eliminated this association. This indicates that the impact of decriminalization policies on overdose rates is complex and influenced by changes in the drug supply[3].

Future Directions

Research and Policy

Future research should focus on optimal naloxone dosing in community settings and the impact of drug policies on overdose rates, accounting for changes in the composition of unregulated drug markets.

Public Health Strategies

Public health strategies must be multifaceted, including harm reduction measures, rapid adaptation to new opioids in the drug supply, and robust surveillance systems to track trends in overdose deaths.

Key Takeaways

• Optimized Naloxone Dosing: Clinical trials suggest that tailored naloxone dosing strategies can be more effective in managing fentanyl overdoses.
• Market Availability: Fentanyl is widely available on darknet markets, contributing to its high potency and lethal impact.
• Regional Trends: The impact of fentanyl varies by region, with significant increases in overdose deaths involving IMFs and carfentanil in certain areas.
• Public Health Implications: Adaptive overdose prevention strategies and robust surveillance are crucial in addressing the ongoing opioid crisis.
• Policy Considerations: Drug policies, including decriminalization, must be evaluated in the context of changing drug market compositions.

FAQs

Q: What are the key findings from the clinical trial on naloxone dosing strategies for fentanyl overdose?

A: The trial found that administering naloxone in multiple doses at specific intervals significantly increased naloxone plasma concentrations, which could be more effective in managing fentanyl overdoses.

Q: How is fentanyl distributed on darknet markets?

A: Fentanyl is distributed on darknet markets through vendors who often offer worldwide shipping, with Chinese and South American crime groups dominating the supply.

Q: What is the impact of carfentanil on overdose deaths?

A: Carfentanil, 100 times more potent than fentanyl, has seen a significant increase in detection in overdose deaths, with a sevenfold increase in the U.S. from January-June 2023 to January-June 2024.

Q: How does drug decriminalization affect overdose rates?

A: The impact of drug decriminalization on overdose rates is complex and influenced by changes in the drug supply. Adjusting for the spread of fentanyl eliminates the positive association between decriminalization and overdose rates.

Q: What are the implications for public health practice in addressing fentanyl overdoses?

A: Public health efforts should include adaptive overdose prevention strategies, robust surveillance systems, and harm reduction measures to address the widespread presence of IMFs and other potent opioids.

Sources

1. Intranasal Naloxone Repeat Dosing Strategies and Fentanyl Overdose. JAMA Network Open, 2024.
2. Fentanyl availability on darknet markets. Australian Institute of Criminology, 2020.
3. Drug Decriminalization, Fentanyl, and Fatal Overdoses in Oregon. JAMA Network Open, 2024.
4. Detection of Illegally Manufactured Fentanyls and Carfentanil. CDC, 2024.