CLINICAL TRIALS PROFILE FOR FENTANYL-50

505(b)(2) Clinical Trials for FENTANYL-50

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	NCT01717157 ↗	A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers	Completed	Janssen Research & Development, LLC	Phase 1	2012-08-01	The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of 4 new formulations of fentanyl transdermal patch in healthy participants after a single application for 72 hours.
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-50

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00027014 ↗	Herb-Opioid Interactions	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 4	2001-09-01	This is a series of studies in healthy volunteers to assess the potential for adverse interactions between St. John's wort (SJW) extract and two narcotic (opioid) pain medications: oxycodone and fentanyl. In the case of oxycodone, we are interested in whether SJW treatment promotes the metabolism of oxycodone, such that it lowers the effectiveness of standard doses of oxycodone in treating pain problems. For the fentanyl study, we will investigate whether SJW treatment will interfere with the delivery of fentanyl to the brain and diminish it's effectiveness to relieve pain. There is evidence to suggest that SJW treatment may increase the activity of a transporter protein, named P-glycoprotein (Pgp), in the blood-brain barrier (BBB) that protects the brain from exposure to drugs and other dietary and environmental toxins.
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-50

Condition Name

Condition Name for FENTANYL-50
Intervention	Trials
Pain	161
Postoperative Pain	107
Pain, Postoperative	92
Anesthesia	85

Condition MeSH

Condition MeSH for FENTANYL-50
Intervention	Trials
Pain, Postoperative	247
Acute Pain	56
Vomiting	46
Breakthrough Pain	43

Clinical Trial Locations for FENTANYL-50

Trials by Country

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

Clinical Trial Progress for FENTANYL-50

Clinical Trial Phase

Clinical Trial Phase for FENTANYL-50
Clinical Trial Phase	Trials
Phase 4	564
Phase 3	200
Phase 2/Phase 3	51

Clinical Trial Status

Clinical Trial Status for FENTANYL-50
Clinical Trial Phase	Trials
Completed	890
Recruiting	230
Unknown status	195

Clinical Trial Sponsors for FENTANYL-50

Sponsor Name

Sponsor Name for FENTANYL-50
Sponsor	Trials
Cairo University	47
Ain Shams University	40
Mansoura University	38

Sponsor Type

Sponsor Type for FENTANYL-50
Sponsor	Trials
Other	1765
Industry	254
U.S. Fed	33

Fentanyl-50: Clinical Trials, Market Analysis, and Projections

Introduction to Fentanyl-50

Fentanyl-50, a formulation of the potent opioid fentanyl, is used primarily for managing severe pain, particularly in patients who are tolerant to other opioids. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Analgesic Effects and Pharmacokinetics

A significant clinical trial involving transdermal fentanyl patches, including the Fentanyl-50 formulation, was conducted to assess its analgesic, pharmacokinetic, and clinical respiratory effects. In this study, patients undergoing abdominal hysterectomy were administered either Fentanyl-50 (50 micrograms/h) or Fentanyl-75 (75 micrograms/h) patches, or placebo patches. The results showed that the Fentanyl-75 group had significantly lower visual analog scale pain scores and reduced the need for supplemental morphine postoperatively. However, both Fentanyl groups experienced increased abnormal respiratory patterns and required more oxygen supplementation compared to the placebo group[1].

Safety and Adverse Effects

The same trial highlighted significant safety concerns, including severe respiratory depression. Nine patients in the Fentanyl groups were withdrawn due to severe respiratory depression, whereas none in the placebo group experienced this issue. Despite these risks, there were no significant differences in the incidence of nausea, vomiting, or pruritus among the groups[1].

Market Analysis

Illicit Market and Darknet Presence

Fentanyl, including formulations like Fentanyl-50, has a significant presence on the illicit market, particularly on darknet platforms. These markets allow for the anonymous distribution of small quantities of fentanyl, often mixed with other drugs like cocaine, Xanax, and heroin. The potency of fentanyl amplifies its impact, making it a high-value, low-mass commodity. For instance, a mere 16.8 milligrams of fentanyl extracted from a 100-microgram transdermal patch can produce a substantial amount of heroin equivalent, valued highly in the illicit market[2].

Legal Market and Prescription Trends

In the legal market, fentanyl is prescribed for severe pain management, particularly for patients who have developed tolerance to other opioids. However, the legal market is heavily regulated, and prescriptions are tightly controlled due to the drug's high potential for abuse and overdose.

Projections and Future Trends

Regulatory Challenges

The illicit distribution of fentanyl and its analogs poses significant regulatory challenges. The efficiency and anonymity of darknet markets, combined with global supply chains, make it difficult to regulate the manufacture and distribution of these drugs. Efforts to combat this include enhanced surveillance and cooperation between law enforcement agencies across borders[5].

Treatment and Prevention

Given the complexities of treating opioid use disorder (OUD) involving fentanyl, there is a growing need for innovative treatment strategies. A recent breakthrough involves the development of a fentanyl vaccine that could prevent the drug from entering the brain, thereby eliminating its euphoric effects. This vaccine, currently in the preclinical stages, shows promise as a relapse prevention agent for individuals trying to quit using opioids. It is expected to undergo clinical trials in humans soon[4].

Market Impact of New Treatments

The introduction of a fentanyl vaccine could significantly alter the market dynamics. If successful, it could reduce the demand for illicit fentanyl and decrease the number of overdose cases. This would also impact the prescription market, as current treatments like methadone, buprenorphine, and naltrexone may see reduced usage in favor of vaccination as a preventive measure.

Challenges in Addressing Fentanyl Use

Complicating Factors in Addiction Treatment

Fentanyl's presence complicates the treatment of opioid and polydrug addiction. Its pharmacodynamics require different treatment approaches compared to semisynthetic opiates. Research is ongoing to understand these differences and to develop novel treatment strategies, including the design of mechanism-based treatments and the development of new medications or therapeutic devices[3].

Public Health Implications

The public health implications of fentanyl use are severe. The drug's potency and widespread availability contribute to a high risk of overdose deaths. Public health initiatives must focus on harm reduction, self-medicated recovery, and education about the dangers of fentanyl-laced street drugs.

Key Takeaways

• Clinical Efficacy: Fentanyl-50 is effective in pain management but comes with significant risks, including respiratory depression.
• Illicit Market: Fentanyl has a substantial presence on darknet markets, contributing to the opioid crisis.
• Regulatory Challenges: The global and anonymous nature of darknet markets complicates regulatory efforts.
• Innovative Treatments: The development of a fentanyl vaccine offers hope as a relapse prevention agent.
• Market Impact: Successful introduction of a fentanyl vaccine could alter market dynamics and reduce overdose cases.

FAQs

What are the primary risks associated with Fentanyl-50?

The primary risks include severe respiratory depression, increased need for oxygen supplementation, and the potential for overdose.

How is Fentanyl-50 used in the illicit market?

Fentanyl-50 is often extracted from transdermal patches and mixed with other street drugs, increasing the risk of overdose for users who may not be aware of its presence.

What is the current status of the fentanyl vaccine?

The fentanyl vaccine is in the preclinical stages and has shown promise in lab studies. Clinical trials in humans are planned soon.

How does the fentanyl vaccine work?

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

What are the implications of the fentanyl vaccine for the opioid epidemic?

If successful, the vaccine could significantly reduce relapse rates and overdose deaths, offering a new tool in the fight against the opioid epidemic.

Sources

1. PubMed: A double-blind, placebo-controlled trial of transdermal fentanyl after abdominal hysterectomy.
2. Australian Institute of Criminology: Fentanyl availability on darknet markets.
3. NIH Grants: Fentanyl and its Analogs.
4. University of Houston: Fentanyl Vaccine Potential 'Game Changer' for Opioid Epidemic.
5. PNNL: Fentanyl Analogs.