CLINICAL TRIALS PROFILE FOR FENTANYL-100

505(b)(2) Clinical Trials for Fentanyl-100

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 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.
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.

All Clinical Trials for Fentanyl-100

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.
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.

Clinical Trial Conditions for Fentanyl-100

Condition Name

Condition Name for Fentanyl-100
Intervention	Trials
Pain	161
Postoperative Pain	107
Pain, Postoperative	92
Anesthesia	85

Condition MeSH

Condition MeSH for Fentanyl-100
Intervention	Trials
Pain, Postoperative	247
Acute Pain	56
Vomiting	46
Breakthrough Pain	43

Clinical Trial Locations for Fentanyl-100

Trials by Country

Trials by Country for Fentanyl-100
Location	Trials
United States	865
Egypt	270
Canada	99
China	81
Korea, Republic of	71

Trials by US State

Trials by US State for Fentanyl-100
Location	Trials
California	77
New York	63
Texas	62
North Carolina	50
Illinois	44

Clinical Trial Progress for Fentanyl-100

Clinical Trial Phase

Clinical Trial Phase for Fentanyl-100
Clinical Trial Phase	Trials
Phase 4	564
Phase 3	200
Phase 2/Phase 3	51

Clinical Trial Status

Clinical Trial Status for Fentanyl-100
Clinical Trial Phase	Trials
Completed	890
Recruiting	230
Unknown status	195

Clinical Trial Sponsors for Fentanyl-100

Sponsor Name

Sponsor Name for Fentanyl-100
Sponsor	Trials
Cairo University	47
Ain Shams University	40
Mansoura University	38

Sponsor Type

Sponsor Type for Fentanyl-100
Sponsor	Trials
Other	1765
Industry	254
U.S. Fed	33

The Fentanyl Crisis and the Quest for a Solution: Updates on the Fentanyl Vaccine and Market Analysis

Introduction

Fentanyl, a highly potent synthetic opioid, has become a significant threat to public health globally, particularly in the United States. Its widespread misuse and the resulting overdose deaths have prompted urgent calls for innovative solutions. One such solution is the development of a fentanyl vaccine, which could potentially revolutionize the treatment of opioid use disorder (OUD). Here, we will delve into the latest updates on clinical trials for the fentanyl vaccine, analyze the current market dynamics, and project future trends.

The Fentanyl Epidemic: A Public Health Crisis

Fentanyl is 50 times more potent than heroin and 100 times more potent than morphine, making it a highly addictive and deadly substance. The DEA has reported that six out of ten fentanyl-laced fake prescription pills now contain a potentially lethal dose of fentanyl, highlighting the escalating danger[5].

Development of the Fentanyl Vaccine

A research team led by the University of Houston has made a groundbreaking discovery with the development of a vaccine targeting fentanyl. This vaccine generates anti-fentanyl antibodies that bind to consumed fentanyl, preventing it from entering the brain and thus eliminating the euphoric effects. This breakthrough could serve as a relapse prevention agent for individuals trying to quit using opioids[1].

Clinical Trials Update

The vaccine has shown promising results in lab studies, with no adverse side effects observed in immunized rats. The anti-fentanyl antibodies were specific to fentanyl and its derivatives, ensuring that other opioids could still be used for pain relief. The team is planning to start manufacturing clinical-grade vaccine in the coming months, with human clinical trials scheduled to begin soon[1].

Market Analysis: The Illicit Fentanyl Trade

Darknet Markets and Global Distribution

Fentanyl and its analogues are widely available on darknet markets, facilitating a global trade in these highly potent synthetic opioids. The efficiency and anonymity of these markets, combined with the use of postal services for distribution, make it challenging to regulate the manufacture and distribution of fentanyl. Chinese and South American crime groups dominate this illicit trade, adapting to the opportunities offered by darknet markets[2].

Economic Impact

The illicit fentanyl market is highly lucrative. For instance, ten grams of fentanyl purchased on the darknet can produce the equivalent of one kilogram of synthetic heroin, valued at between A$160,000 and A$195,000 in the Australian domestic illicit market. This makes the Australian drug market one of the most expensive in the world[2].

Cartel Involvement

Mexican cartels, particularly the Sinaloa and Jalisco cartels, are major players in the production and trafficking of fentanyl-laced fake prescription pills. These pills are often indistinguishable from real prescription medications and are frequently deadly. The DEA has seized millions of these pills, highlighting the scale of the problem[5].

Market Projections

Potential Impact of the Fentanyl Vaccine

If the fentanyl vaccine proves successful in clinical trials, it could significantly alter the landscape of OUD treatment. Here are a few potential market projections:

Reduction in Overdose Deaths

The vaccine could lead to a substantial reduction in fentanyl-related overdose deaths by preventing the drug from producing its euphoric effects. This would not only save lives but also reduce the economic burden associated with emergency medical responses and long-term healthcare costs.

Shift in Treatment Paradigms

Current treatments for OUD, such as methadone, buprenorphine, and naltrexone, have limitations in terms of formulation, compliance, and access. A vaccine could offer a more reliable and long-term solution, potentially reducing the demand for these traditional treatments and shifting market dynamics.

Regulatory and Legal Implications

The introduction of a fentanyl vaccine could prompt regulatory changes, such as stricter controls on the prescription and distribution of opioids. It may also lead to increased legal actions against cartels and individuals involved in the illicit fentanyl trade.

Challenges and Considerations

Regulatory Hurdles

Before the vaccine can be widely available, it must navigate through rigorous clinical trials and regulatory approvals. The FDA has a history of scrutinizing opioid-related treatments, as seen with the approval and subsequent revisions of fentanyl products like Fentora[3].

Public Awareness and Education

Public awareness campaigns will be crucial to educate individuals about the dangers of fentanyl and the potential benefits of the vaccine. This is particularly important given the widespread misuse of fentanyl-laced fake prescription pills.

Access and Equity

Ensuring equitable access to the vaccine will be a significant challenge. The cost of development and production, combined with potential regulatory barriers, could limit availability, especially in underserved communities.

Key Takeaways

• Vaccine Development: A fentanyl vaccine is in development, showing promise in lab studies by preventing fentanyl from entering the brain.
• Clinical Trials: Human clinical trials are planned to start soon after the manufacturing of clinical-grade vaccine.
• Market Dynamics: The illicit fentanyl trade is dominated by darknet markets and Mexican cartels, with significant economic and public health impacts.
• Potential Impact: The vaccine could reduce overdose deaths, shift treatment paradigms, and lead to regulatory and legal changes.
• Challenges: Regulatory hurdles, public awareness, and access equity are critical considerations for the successful implementation of the vaccine.

FAQs

Q: How does the fentanyl vaccine work?

A: The fentanyl vaccine generates anti-fentanyl antibodies that bind to consumed fentanyl, preventing it from entering the brain and thus eliminating the euphoric effects.

Q: What are the current treatments for opioid use disorder (OUD)?

A: Current treatments include methadone, buprenorphine, and naltrexone, each with its own limitations in terms of formulation, compliance, and access.

Q: Why is fentanyl so dangerous?

A: Fentanyl is highly addictive and 50 times more potent than heroin and 100 times more potent than morphine, making even small doses potentially lethal.

Q: Who are the main players in the illicit fentanyl trade?

A: Mexican cartels, particularly the Sinaloa and Jalisco cartels, are major players in the production and trafficking of fentanyl-laced fake prescription pills.

Q: What are the potential economic impacts of the fentanyl vaccine?

A: The vaccine could reduce healthcare costs associated with emergency medical responses and long-term care for OUD, as well as impact the illicit opioid market by reducing demand.

Sources

1. University of Houston News: "Fentanyl Vaccine Potential 'Game Changer' for Opioid Epidemic"
2. Australian Institute of Criminology: "Fentanyl availability on darknet markets"
3. FDA: "Overdose Prevention Activities Timeline"
4. FDA: "Duragesic - accessdata.fda.gov"
5. DEA: "DEA Laboratory Testing Reveals that 6 out of 10 Fentanyl-Laced Fake Prescription Pills Now Contain a Potentially Lethal Dose of Fentanyl"

Last updated: 2024-12-31