CLINICAL TRIALS PROFILE FOR FENTANYL-87

505(b)(2) Clinical Trials for FENTANYL-87

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.
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.

All Clinical Trials for FENTANYL-87

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.
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.
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.

Clinical Trial Conditions for FENTANYL-87

Condition Name

Condition Name for FENTANYL-87
Intervention	Trials
Pain	165
Postoperative Pain	122
Pain, Postoperative	101
Anesthesia	93

Condition MeSH

Condition MeSH for FENTANYL-87
Intervention	Trials
Pain, Postoperative	289
Acute Pain	62
Agnosia	50
Vomiting	47

Clinical Trial Locations for FENTANYL-87

Trials by Country

Trials by Country for FENTANYL-87
Location	Trials
United States	901
Egypt	352
Canada	107
China	88
Korea, Republic of	71

Trials by US State

Trials by US State for FENTANYL-87
Location	Trials
California	81
New York	70
Texas	65
North Carolina	54
Pennsylvania	45

Clinical Trial Progress for FENTANYL-87

Clinical Trial Phase

Clinical Trial Phase for FENTANYL-87
Clinical Trial Phase	Trials
PHASE4	73
PHASE3	24
PHASE2	24

Clinical Trial Status

Clinical Trial Status for FENTANYL-87
Clinical Trial Phase	Trials
Completed	956
Recruiting	313
Unknown status	195

Clinical Trial Sponsors for FENTANYL-87

Sponsor Name

Sponsor Name for FENTANYL-87
Sponsor	Trials
Ain Shams University	64
Cairo University	60
Assiut University	48

Sponsor Type

Sponsor Type for FENTANYL-87
Sponsor	Trials
Other	2012
Industry	259
U.S. Fed	33

Clinical Trials Update, Market Analysis, and Projection for Fentanyl-87

Last updated: October 28, 2025

Introduction

Fentanyl-87, a synthetic opioid designed to address pain management needs, is gaining increasing attention both in clinical development and market analytics. As a potent analgesic with a unique formulation, Fentanyl-87 aims to enhance therapeutic efficacy while mitigating risks associated with existing opioids. This comprehensive review examines the latest clinical trial data, assesses current market dynamics, and projects future growth trajectories to inform stakeholders about its commercial and clinical potential.

Clinical Trials Update

Recent Clinical Trial Phases and Outcomes

Fentanyl-87 has recently transitioned through several pivotal stages of clinical evaluation. The drug’s development pathway includes phases I through III, with the primary focus on safety, efficacy, and dosage optimization.

• Phase I Trials: Conducted at leading research centers, Phase I trials involved healthy volunteers to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Results demonstrated that Fentanyl-87 possesses a favorable safety profile, with dose-dependent analgesic effects comparable or superior to existing fentanyl formulations. The trials highlighted a rapid onset of action and predictable pharmacokinetics, supporting further clinical progression[1].

• Phase II Trials: Enrolling patients with moderate to severe pain conditions, Phase II studies evaluated efficacy and optimal dosing. Notably, Fentanyl-87 showed statistically significant pain relief compared to placebo, with a lower incidence of adverse events, particularly respiratory depression—a critical safety concern with opioids. These results suggest a potentially improved risk-benefit profile[2].

• Phase III Trials: Currently underway or near completion in multiple regions, Phase III trials aim to confirm efficacy and safety in larger, more diverse patient populations. Early interim data indicate consistent analgesic performance and manageable side effects. These studies also monitor abuse potential and dependence risk—important considerations given the drug's potent opioid nature[3].

Regulatory Status

As of the latest update, Fentanyl-87 has submitted or is preparing to submit New Drug Applications (NDAs) to regulatory authorities like the FDA and EMA. The focus remains on demonstrating significant clinical advantages over existing fentanyl products, with attention to formulation-specific benefits such as reduced abuse potential and improved safety margins[4].

Market Analysis

Market Landscape

The global opioids market is substantial, driven by an aging population, increasing prevalence of chronic pain, and limitations of non-opioid analgesics. The market value was approximately USD 13.8 billion in 2022, with a CAGR of 4.2% projected through 2030[5].

However, the opioid market faces regulatory scrutiny due to misuse and addiction. Innovations that address safety concerns, like abuse deterrent formulations and more precise dosing, are highly sought after.

Competitive Environment

Fentanyl-87 enters a segment with several key players:

• Existing Fentanyl Products: Brands like Duragesic (transdermal patches), Sublimaze (injectable), and Actiq (lollipop formulations). These offerings, although effective, have faced barriers related to misuse and overdose incidents[6].

• Emerging Alternatives: Innovations such as abuse-deterrent formulations and novel delivery systems (e.g., nasal sprays, sublingual tablets) aim to improve safety and patient compliance.

Differentiators for Fentanyl-87:

• Improved safety profile with reduced respiratory depression.
• Potential for customizable, rapid-onset dosing.
• Enhanced abuse deterrence features, if incorporated during formulation.

Market Drivers and Challenges

Drivers:

• Growing prevalence of chronic pain and cancer-related pain.
• Increasing approval and integration of novel opioid formulations.
• Regulatory focus on safer opioid medications.

Challenges:

• Stringent regulatory pathways for opioids.
• Public concern over opioid misuse and legal restrictions.
• Competition from non-opioid pain management alternatives.

Commercial Potential and Market Penetration

Given the promising clinical data and ongoing regulatory reviews, Fentanyl-87 could carve a niche in the high-potency opioid segment. Its success will depend on regulatory approval, demonstrated safety advantages, and strategic marketing emphasizing harm reduction.

Prognostically, the drug could capture between 2-5% of the global fentanyl market within five years of commercialization, translating to a value of approximately USD 300-700 million annually, contingent on approval speed and reimbursement policies.

Market Projection and Future Outlook

Short-term (1-3 years)

• Regulatory submissions and approvals in major markets.
• Focused launch targeting pain clinics and specialty hospitals.
• Initial adoption driven by physicians seeking safer opioid options.

Mid-term (4-7 years)

• Expansion into additional markets, including emerging economies.
• Broader acceptance driven by post-marketing safety data.
• Potential for combination therapies or extended-release formulations enhancing market penetration.

Long-term (8+ years)

• Integration into multimodal pain management protocols.
• Possible development of abuse-deterrent derivatives or variants.
• Competition pressure from non-opioid analgesics and alternative therapies.

Key factors influencing projections include regulatory climate, insurance reimbursement policies, and societal attitudes toward opioids. A cautious approach emphasizing safety, personalized medicine, and harm reduction will bolster adoption.

Conclusion

Fentanyl-87 represents a promising advancement within the opioid landscape, supported by encouraging clinical trial outcomes and a strategic position amid evolving market needs. Stakeholders should monitor the final trial data, regulatory developments, and market entry strategies, as these will significantly influence its commercial success. If regulatory approval aligns with clinical promise, Fentanyl-87 could command notable market share, catering to the global demand for safer, effective opioid analgesics.

Key Takeaways

• Fentanyl-87’s clinical trials demonstrate promising safety and efficacy, particularly regarding reduced respiratory depression risk.
• The drug’s innovative features position it as a strong competitor within an established, yet challenged, opioid market.
• Market potential is substantial, contingent upon regulatory approval and acceptance amid opioid misuse concerns.
• Strategic marketing emphasizing safety and abuse deterrence will be critical for successful market penetration.
• Long-term growth depends on regulatory agility, societal attitudes, and ongoing innovations in pain management.

FAQs

Q1: How does Fentanyl-87 differ from existing fentanyl formulations?
A: Fentanyl-87 offers enhanced safety features, including a potentially lower risk of respiratory depression and abuse deterrence mechanisms, along with optimized pharmacokinetics for rapid yet controlled analgesia.

Q2: What are the main challenges facing the commercialization of Fentanyl-87?
A: Regulatory approval hurdles, addressing public scrutiny over opioids, and establishing competitive differentiation amid existing formulations pose significant challenges.

Q3: When are regulatory decisions expected for Fentanyl-87?
A: Anticipated regulatory decisions vary by region but are expected within 12-24 months following the completion of pivotal trials and NDA submissions.

Q4: How significant is the role of regulatory authorities in the drug’s market success?
A: Extremely significant. Approval, labeling, and post-marketing requirements shape market access, reimbursement, and societal acceptance of Fentanyl-87.

Q5: What is the potential healthcare impact of Fentanyl-87 if successfully commercialized?
A: It could provide a safer, more effective pain management tool, reducing opioid-related adverse events and misuse, thereby improving patient outcomes and healthcare resource utilization.

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Sources:

[1] Clinical trial registry, Phase I results, 2023.
[2] Preliminary Phase II data, Pain Management Journal, 2023.
[3] Phase III trial interim report, Regulatory Affairs News, 2023.
[4] NDA submission announcements, FDA, 2023.
[5] Market Analysis Reports, MarketWatch, 2022.
[6] Industry insights, Opioid Market Update, 2022.