CLINICAL TRIALS PROFILE FOR FENTANYL HYDROCHLORIDE

505(b)(2) Clinical Trials for fentanyl hydrochloride

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 hydrochloride

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 hydrochloride

Condition Name

Condition Name for fentanyl hydrochloride
Intervention	Trials
PAIN	161
Postoperative Pain	107
Pain, Postoperative	92
Anesthesia	85

Condition MeSH

Condition MeSH for fentanyl hydrochloride
Intervention	Trials
Pain, Postoperative	247
Acute Pain	56
Vomiting	46
Breakthrough Pain	43

Clinical Trial Locations for fentanyl hydrochloride

Trials by Country

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

Clinical Trial Progress for fentanyl hydrochloride

Clinical Trial Phase

Clinical Trial Phase for fentanyl hydrochloride
Clinical Trial Phase	Trials
Phase 4	564
Phase 3	200
Phase 2/Phase 3	51

Clinical Trial Status

Clinical Trial Status for fentanyl hydrochloride
Clinical Trial Phase	Trials
Completed	890
Recruiting	230
Unknown status	195

Clinical Trial Sponsors for fentanyl hydrochloride

Sponsor Name

Sponsor Name for fentanyl hydrochloride
Sponsor	Trials
Cairo University	47
Ain Shams University	40
Mansoura University	38

Sponsor Type

Sponsor Type for fentanyl hydrochloride
Sponsor	Trials
Other	1765
Industry	254
U.S. Fed	33

Fentanyl Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Fentanyl Hydrochloride

Fentanyl hydrochloride is a potent synthetic opioid used primarily for pain management, especially in cases where other opioids are ineffective. It is known for its rapid onset and short duration of action, making it a versatile option in both clinical and illicit contexts. However, its potency also contributes to the ongoing opioid crisis, highlighting the need for careful management and innovative treatments.

Clinical Trials and Research

Reversal of Fentanyl-Induced Respiratory Depression

Recent clinical trials have focused on the reversal of fentanyl-induced respiratory depression, a critical aspect of opioid overdose treatment. A study by Purdue Pharma explored the efficacy of nalmefene and naloxone in reversing respiratory depression caused by fentanyl. The results indicated that nalmefene (1 mg) was as effective as, or even better than, intramuscular (IM) naloxone and intranasal (IN) naloxone in reversing fentanyl-induced respiratory depression[1].

Patient-Controlled Transdermal Fentanyl

Another area of research involves the development of patient-controlled transdermal fentanyl systems. These systems use iontophoresis and electrotransport delivery platform technology to deliver small doses of fentanyl through the skin, potentially reducing the risks associated with traditional intravenous patient-controlled analgesia (PCA) systems. This method aims to improve patient safety and pain control postoperatively[4].

FDA Initiatives and Approvals

The FDA has been actively involved in advancing the development of treatments for opioid use disorder (OUD). Recent approvals include generic versions of extended-release injectable naltrexone and extended-release injectable buprenorphine for the treatment of moderate-to-severe OUD. The FDA also continues to clarify premarket expectations for medical devices intended to treat OUD, engaging with sponsors through the Q-submission program[3].

Market Analysis

Global Opioids Market Size

The global opioids market was valued at approximately $22.74 billion in 2023 and is projected to reach around $26.78 billion by 2034, growing at a CAGR of 1.5%. North America currently holds the highest market share, accounting for 45.13% of the global market in 2023. The Asia-Pacific region is expected to expand at the fastest CAGR during the forecast period[2].

Market Segmentation

• By Application: The pain relief segment dominated the market with a 24% share in 2023. The anesthesia segment is anticipated to grow at the fastest CAGR over the projected period.
• By Route of Administration: The injectable segment held the highest revenue share of 44% in 2023, while the oral segment is expected to expand at a CAGR of 2.5% over the predicted period.
• By Distribution Channel: Retail pharmacies led the market with a maximum share of 38% in 2023, with the three-dimensional segment growing at a CAGR of 2.8% over the predicted period[2].

Key Players

Major players in the opioids market include Purdue Pharmaceuticals L.P., Teva Pharmaceuticals Inc., Sun Pharmaceutical Industries Ltd, Mallinckrodt Pharmaceuticals LLC, and Amneal Pharmaceuticals Inc., among others. These companies are actively involved in developing new treatments, settling legal issues related to opioid sales, and expanding their product portfolios[2].

Projections and Future Outlook

Growing Need for Opioid Antagonists

The increasing prevalence of fatal overdoses involving synthetic opioids like fentanyl and carfentanil underscores the need for stronger, longer-acting opioid antagonist treatments. In response, there has been a call for the development of such treatments, with companies like Purdue Pharma committing to research and distribution of opioid overdose reversal agents[1].

Regulatory and Policy Initiatives

The Biden-Harris Administration has launched initiatives to support opioid treatment and recovery services, particularly in rural communities. For instance, a nearly $50 million initiative was announced in March 2024 to enhance these services. Such initiatives are expected to drive the demand for effective opioid treatments and reversal agents[2].

Technological Advancements

Advancements in drug delivery systems, such as the patient-controlled transdermal fentanyl system, are expected to improve safety and efficacy. These innovations could shift market dynamics by offering safer alternatives to traditional opioid delivery methods[4].

Safety and Regulatory Considerations

Important Safety Information

Nalmefene Hydrochloride Injection, used for the reversal of opioid-induced respiratory depression, has specific indications and contraindications. It is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, but should be used with caution due to potential side effects and interactions[1].

FDA Overdose Prevention Framework

The FDA's Overdose Prevention Framework includes activities such as advancing the development of evidence-based treatments for substance use disorders and clarifying premarket expectations for medical devices intended to treat OUD. This framework is crucial for ensuring that new treatments meet stringent safety and efficacy standards[3].

Illicit Fentanyl and Public Health Implications

Fentanyl Purity and Seizures

The purity of illicit fentanyl has significantly increased, with average purity levels rising from 2.8% to 11.9% for samples weighing less than 1 kg since 2017. This increase in purity, combined with the widespread availability of fentanyl in various forms (powders, tablets), exacerbates the public health crisis[5].

Public Health Response

The DEA and other federal agencies are working to combat the illicit fentanyl crisis through enhanced seizures, improved testing methods, and public awareness campaigns. The FDA's approval of over-the-counter naloxone hydrochloride nasal spray, as seen with Amneal's product in April 2024, is a significant step in making emergency opioid overdose treatment more accessible[2][5].

Key Takeaways

• Clinical Trials: Recent studies focus on reversing fentanyl-induced respiratory depression using nalmefene and naloxone, and developing safer opioid delivery systems.
• Market Analysis: The global opioids market is projected to grow to $26.78 billion by 2034, with North America leading and the Asia-Pacific region growing at the fastest CAGR.
• Regulatory Initiatives: The FDA and other agencies are actively involved in advancing treatments for OUD and ensuring safety through regulatory frameworks.
• Public Health: The increasing purity and availability of illicit fentanyl pose significant public health risks, necessitating robust responses from regulatory and healthcare sectors.

FAQs

What is the current state of clinical trials for fentanyl hydrochloride?

Clinical trials are focusing on the reversal of fentanyl-induced respiratory depression using agents like nalmefene and naloxone, as well as developing safer delivery systems such as patient-controlled transdermal fentanyl.

How is the global opioids market projected to grow?

The global opioids market is expected to grow from $22.74 billion in 2023 to around $26.78 billion by 2034, with a CAGR of 1.5%.

What are the key segments driving the opioids market?

The pain relief and anesthesia segments are significant, with the injectable route of administration holding the highest revenue share. Retail pharmacies are the leading distribution channel.

What regulatory initiatives are in place to address the opioid crisis?

The FDA has an Overdose Prevention Framework that includes advancing evidence-based treatments and clarifying premarket expectations for medical devices. Additionally, initiatives like the Biden-Harris Administration's $50 million funding for opioid treatment in rural communities are underway.

How has the purity of illicit fentanyl changed over time?

The average purity of illicit fentanyl has significantly increased since 2017, posing a greater public health risk due to its potency.

Sources

1. Purdue Pharma. New Study Explores Nalmefene and Naloxone for Reversal of Respiratory Depression Induced by Fentanyl in a Clinical Opioid-Induced Respiratory Depression Model. October 28, 2024.
2. Biospace. Opioids Market Size to Worth Around USD 26.78 Billion by 2034. July 17, 2024.
3. FDA. An Update on FDA's Overdose Prevention Framework. August 31, 2023.
4. JAMA Network. Patient-Controlled Transdermal Fentanyl Hydrochloride vs Intravenous Morphine Pump for Postoperative Pain: A Randomized Controlled Trial.
5. DEA. Summary and Key Findings - FPP Report CY 2021. August 2022.