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Last Updated: April 7, 2025

CLINICAL TRIALS PROFILE FOR FENTANYL-62


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505(b)(2) Clinical Trials for FENTANYL-62

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
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.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

All Clinical Trials for FENTANYL-62

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for FENTANYL-62

Condition Name

16110792850020406080100120140160PainPostoperative PainPain, PostoperativeAnesthesia[disabled in preview]
Condition Name for FENTANYL-62
Intervention Trials
Pain 161
Postoperative Pain 107
Pain, Postoperative 92
Anesthesia 85
[disabled in preview] 0
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Condition MeSH

2475646430050100150200250Pain, PostoperativeAcute PainVomitingBreakthrough Pain[disabled in preview]
Condition MeSH for FENTANYL-62
Intervention Trials
Pain, Postoperative 247
Acute Pain 56
Vomiting 46
Breakthrough Pain 43
[disabled in preview] 0
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Clinical Trial Locations for FENTANYL-62

Trials by Country

+
Trials by Country for FENTANYL-62
Location Trials
United States 865
Egypt 270
Canada 99
China 81
Korea, Republic of 71
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Trials by US State

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

Clinical Trial Phase

60.1%21.3%5.4%13.1%0050100150200250300350400450500550600Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for FENTANYL-62
Clinical Trial Phase Trials
Phase 4 564
Phase 3 200
Phase 2/Phase 3 51
[disabled in preview] 123
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Clinical Trial Status

60.6%15.7%13.3%10.5%0100200300400500600700800900CompletedRecruitingUnknown status[disabled in preview]
Clinical Trial Status for FENTANYL-62
Clinical Trial Phase Trials
Completed 890
Recruiting 230
Unknown status 195
[disabled in preview] 154
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Clinical Trial Sponsors for FENTANYL-62

Sponsor Name

trials05101520253035404550Cairo UniversityAin Shams UniversityMansoura University[disabled in preview]
Sponsor Name for FENTANYL-62
Sponsor Trials
Cairo University 47
Ain Shams University 40
Mansoura University 38
[disabled in preview] 37
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Sponsor Type

85.1%12.2%0020040060080010001200140016001800OtherIndustryU.S. Fed[disabled in preview]
Sponsor Type for FENTANYL-62
Sponsor Trials
Other 1765
Industry 254
U.S. Fed 33
[disabled in preview] 23
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Fentanyl: Clinical Trials, Market Analysis, and Projections

Introduction to Fentanyl

Fentanyl is a synthetic opioid analgesic that is significantly more potent than morphine and heroin. It is used medically to treat severe pain, particularly in cancer patients, but its illicit manufacture and distribution have led to a surge in overdose deaths.

Clinical Trials: Naloxone and Fentanyl Overdose

Recent clinical trials have focused on strategies to counteract fentanyl overdoses, particularly through the use of naloxone.

Naloxone Repeat Dosing Strategies

A randomized clinical trial conducted in 2021 at Spaulding Clinical Research in Wisconsin investigated the pharmacokinetics of intranasal naloxone using different repeat dosing strategies to rescue patients from simulated fentanyl and carfentanil overdoses. The trial compared the plasma concentrations of naloxone between different dosing regimens and estimated their effects on fentanyl overdose using a physiologic pharmacokinetic-pharmacodynamic model[1].

  • Key Findings:
    • The trial evaluated naloxone administered in various dosing schedules, including single and multiple doses at different time intervals.
    • The primary outcome was the time to achieve higher naloxone plasma concentrations, and secondary outcomes included estimated brain hypoxia time and other pharmacokinetic parameters.
    • The study found that different dosing strategies had significant impacts on naloxone plasma concentrations and the estimated time to rescue patients from fentanyl overdoses.

Market Analysis of Fentanyl

Current 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 CAGR of 6.4% during the forecast period of 2025-2037[3].

Growth Drivers

  • Increasing Cancer Prevalence: The rise in cancer cases globally, particularly among the elderly, drives the demand for fentanyl as it is commonly prescribed for managing severe pain in cancer patients.
  • Global Healthcare Spending: Increased healthcare spending worldwide is expected to boost the market growth.
  • Awareness and New Treatments: Growing awareness about cancer and the development of new treatments contribute to the market expansion.

Market Segmentation

  • End Users: The market is segmented into hospitals, oncology centers, surgical centers, and others. Oncology centers are expected to hold the largest market share due to the specific focus on cancer treatments[3].
  • Route of Administration: The oral film segment is anticipated to garner a significant share due to its safer effects and ease of administration, especially for elderly patients[3].

Regional Market Forecast

  • North America: This region is expected to see significant growth driven by the large number of hospitals and increasing cancer prevalence.
  • Asia Pacific: The region is projected to hold the second-largest share, driven by the rapidly aging population and government initiatives to raise cancer awareness[3].

Public Health Implications of Fentanyl

Opioid Overdose Deaths

Fentanyl and its analogs have been a major factor in the sharp increase in opioid overdose deaths since 2013. Illicitly manufactured fentanyl, often mixed with heroin, has been responsible for a significant portion of these deaths. Fentanyl analogs, such as carfentanil, which is 10,000 times more potent than morphine, also contribute to the complexity of the illicit opioid market[2].

Demographics of Overdose Deaths

  • Gender and Ethnicity: Most overdose deaths involving fentanyl and its analogs are among non-Hispanic white males aged 25-44 years[2].
  • Geographic Distribution: Northeastern states and Missouri have seen a high incidence of fentanyl-related overdose deaths[2].

Illicit Fentanyl and Fentanyl Analogues

Trafficking and Abuse

Illicit fentanyl and its analogues are manufactured by modifying the basic chemical structure of fentanyl. This allows traffickers to create new substances that are not yet scheduled as controlled substances, thereby avoiding legal restrictions. These substances are often distributed through the dark web and social media, leading to rapid adoption and use[5].

Economic Impact

The illicit fentanyl market generates significant revenue. For example, one kilogram of fentanyl can be pressed into pills and sold for millions of dollars, highlighting the lucrative nature of this illegal trade[5].

Clinical Use of Fentanyl

Pain Management

Fentanyl is prescribed for managing sudden episodes of severe pain, particularly in cancer patients. It is available in various forms, including transdermal patches, sublingual tablets, and oral films. Studies have shown that fentanyl and other opioids like buprenorphine are equally efficacious in managing persistent pain, although fentanyl may require higher doses for comparable pain relief[4].

Side Effects and Treatment Outcomes

Clinical studies have indicated that while fentanyl provides significant pain relief, it also comes with side effects such as local skin reactions and systemic adverse effects. Switching between different formulations can help manage these side effects and improve treatment outcomes[4].

Key Takeaways

  • Clinical Trials: Recent trials focus on optimizing naloxone dosing strategies to counteract fentanyl overdoses.
  • Market Growth: The global fentanyl market is driven by increasing cancer prevalence, global healthcare spending, and awareness campaigns.
  • Public Health: Fentanyl and its analogs are major contributors to opioid overdose deaths, with significant public health implications.
  • Illicit Trade: Illicit fentanyl and its analogues pose a significant risk due to their potency and lucrative illegal trade.
  • Clinical Use: Fentanyl is effective in pain management but comes with notable side effects that need careful management.

FAQs

What is the current market size of the global fentanyl market?

The global fentanyl market was valued at over USD 17.02 billion in 2024[3].

How potent is fentanyl compared to morphine?

Fentanyl is approximately 30 times more potent than heroin and significantly more potent than morphine, with some analogs like carfentanil being 10,000 times more potent than morphine[2][5].

What are the primary drivers of the fentanyl market growth?

The market growth is driven by the increasing prevalence of cancer, global healthcare spending, and increased awareness about cancer treatments[3].

What are the common forms of fentanyl administration?

Fentanyl is available in various forms, including transdermal patches, sublingual tablets, buccal tablets, and oral films[3][4].

How does illicit fentanyl distribution impact public health?

Illicit fentanyl and its analogs significantly contribute to opioid overdose deaths and pose a major public health risk due to their high potency and widespread distribution through illicit channels[2][5].

Sources

  1. Intranasal Naloxone Repeat Dosing Strategies and Fentanyl Overdose - JAMA Network Open
  2. Deaths Involving Fentanyl, Fentanyl Analogs, and U-47700 - CDC
  3. Fentanyl Market Size | Growth Analysis 2025-2037 - Research Nester
  4. Feasibility Study of Transdermal Buprenorphine Versus Transdermal Fentanyl - Pain Medicine
  5. Fentanyl Analogues - United States Sentencing Commission

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