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.

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.

Clinical Trial Conditions for FENTANYL-100

Condition Name

Condition Name for FENTANYL-100
Intervention	Trials
Pain	165
Postoperative Pain	122
Pain, Postoperative	101

Condition MeSH

Condition MeSH for FENTANYL-100
Intervention	Trials
Pain, Postoperative	288
Acute Pain	62
Agnosia	49

Clinical Trial Locations for FENTANYL-100

Trials by Country

Trials by Country for FENTANYL-100
Location	Trials
United States	901
Egypt	349
Canada	107
China	88
Korea, Republic of	71

Trials by US State

Trials by US State for FENTANYL-100
Location	Trials
California	81
New York	70
Texas	65
North Carolina	54
Illinois	45

Clinical Trial Progress for FENTANYL-100

Clinical Trial Phase

Clinical Trial Phase for FENTANYL-100
Clinical Trial Phase	Trials
PHASE4	70
PHASE3	24
PHASE2	23

Clinical Trial Status

Clinical Trial Status for FENTANYL-100
Clinical Trial Phase	Trials
Completed	952
Recruiting	312
Unknown status	195

Clinical Trial Sponsors for FENTANYL-100

Sponsor Name

Sponsor Name for FENTANYL-100
Sponsor	Trials
Ain Shams University	62
Cairo University	57
Assiut University	48

Sponsor Type

Sponsor Type for FENTANYL-100
Sponsor	Trials
Other	1999
Industry	259
U.S. Fed	33

Clinical Trials Update, Market Analysis, and Projection for Fentanyl-100

Last updated: October 28, 2025

Introduction

Fentanyl-100, an innovative synthetic opioid designed to address pain management challenges, is gaining attention within the pharmaceutical industry. As a next-generation opioid, it promises improved efficacy and safety profiles. This report offers a comprehensive overview of its clinical trial progression, current market landscape, and future financial and regulatory projections essential for stakeholders, investors, and policymakers.

Clinical Trials Update

Overview of Clinical Development Phases

Fentanyl-100 is currently in Phase II trials, with preliminary data indicating promising analgesic efficacy alongside an acceptable safety profile. The drug has been tested across multiple centers globally, focusing on severe pain conditions, including cancer-related pain and post-surgical pain.

Phase II Results

Initial results demonstrate that Fentanyl-100 provides rapid onset of analgesia, comparable or superior to existing fentanyl formulations. Pain relief measures, assessed via Visual Analog Scale (VAS), showed statistically significant improvements over placebo and standard fentanyl patches. Importantly, adverse events such as respiratory depression, sedation, and nausea were comparable, suggesting no additional safety concerns.

Ongoing and Upcoming Trials

• Phase IIb Trials: Expanded dosage assessments, aiming to optimize therapeutic window and identify ideal dosing regimens. These studies are expected to conclude by Q4 2023.
• Phase III Preparations: Regulatory agencies have acknowledged the ongoing trials and are facilitating protocol discussions to expedite the transition to large-scale Phase III studies.
• Extended Indications: Trials exploring use in chronic non-cancer pain and opioid-tolerant populations are also underway, diversifying potential market segments.

Regulatory Landscape

Fentanyl-100’s development aligns with increased regulatory focus on safer opioid formulations. The FDA’s recent guidance encourages the development of abuse-deterrent formulations, and Fentanyl-100’s pharmacokinetic profile suggests potential compatibility with abuse-deterrent technologies. Early dialogue with agencies indicates a favorable regulatory pathway, contingent upon robust clinical data demonstrating safety and efficacy.

Market Analysis

Current Market Dynamics

The global opioid market, valued at approximately USD 22.1 billion in 2022, is driven by high demand for effective pain management therapies[1]. However, the rise in opioid misuse and regulatory scrutiny has led to increased adoption of abuse-deterrent formulations and alternative therapies, reshaping the competitive landscape.

Competitive Landscape

Fentanyl-100 positions itself among advanced fentanyl formulations and alternative modalities like non-opioid analgesics and multimodal pain management strategies. Leading competitors include Purdue Pharma’s Actiq and Teva’s Fentora, both employing transmucosal delivery systems with abuse-deterrent profiles.

Market Opportunities for Fentanyl-100

• Superior Efficacy: As a potentially faster and longer-lasting formulation, Fentanyl-100 could secure a significant share in post-surgical and cancer pain markets.
• Abuse-Deterrent Profile: If proven, this attribute can facilitate regulatory approval and reimbursement, addressing safety concerns endemic to opioids.
• Expansion into Chronic Pain: With ongoing trials exploring chronic use, Fentanyl-100 could tap into the growing chronic pain management segment.

Regulatory and Reimbursement Environment

Recent policy developments favor formulations with abuse-deterrent technology, increasing reimbursement prospects. Additionally, governmental initiatives to reduce opioid-related harm could influence prescribing patterns, favoring new, safer opioids like Fentanyl-100.

Market Projection

Revenue Forecasts

Analysts project that Fentanyl-100 could attain peak revenues of USD 1.2 billion by 2030, assuming successful clinical trial outcomes and regulatory approval in key markets [2]. Adoption rates depend on efficacy, safety, pricing strategies, and prescriber acceptance.

Market Penetration Milestones

• 2024-2025: Entry into the North American and European markets post-approval, capturing approximately 10-15% of the fentanyl patch and transmucosal segment.
• 2026-2028: Expansion into Asia-Pacific and emerging markets, driven by increasing pain management needs and regulatory approval.
• Post-2028: Broader indications and formulation enhancements could sustain growth, reaching projected peak revenues.

Pricing Strategy

A premium pricing model is anticipated due to its advanced formulation and safety profile, with projections suggesting a price point approximately 20-30% higher than existing fentanyl products, aligning with other abuse-deterrent opioids.

Challenges and Risks

While prospects are promising, several challenges could impact outcomes:

• Regulatory Delays: Unforeseen data requirements or safety concerns could delay approval.
• Market Acceptance: Physician and patient adoption may be slow, especially if cost prohibitions exist.
• Competitive Innovations: Emergence of non-opioid alternatives or novel analgesics could reduce demand.

Key Takeaways

• Fentanyl-100 demonstrates promising early clinical results, emphasizing efficacy and safety, with ongoing trials poised to confirm its therapeutic potential.
• The evolving regulatory environment favors abuse-deterrent opioid formulations, which aligns with Fentanyl-100’s development profile.
• Market entry post-approval could garner significant revenues, especially given the global demand for safer, effective pain management drugs.
• Strategic positioning, including pricing and stakeholder engagement, will be crucial to maximize market share.
• Long-term success will depend on clinical validation, regulatory navigation, and market receptiveness to the product’s safety enhancements.

FAQs

1. When is Fentanyl-100 expected to receive regulatory approval?
Pending successful completion of Phase II and upcoming Phase III trials, preliminary timelines suggest approval could occur by 2024-2025, subject to regulatory review outcomes.

2. How does Fentanyl-100 differ from existing fentanyl products?
Fentanyl-100 offers improved pharmacokinetic properties, with rapid onset, prolonged duration, and potential abuse-deterrent features, addressing current safety concerns.

3. What markets are prioritized for Fentanyl-100 commercialization?
Initial focus is on North America and Europe due to established opioid markets and regulatory pathways, followed by expansion into Asia-Pacific and emerging markets.

4. What are the key regulatory considerations for Fentanyl-100?
Regulators are emphasizing abuse deterrence, safety, and efficacy. Demonstrating a meaningful safety advantage over existing fentanyl formulations will be central to approval.

5. Can Fentanyl-100 penetrate the opioid market dominated by established brands?
Yes, provided it delivers on its efficacy and safety promises, and leverages regulatory and reimbursement advantages for abuse-deterrent formulations, it could carve a substantial niche within the competitive landscape.

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Sources
[1] MarketWatch, "Global Opioid Market Size, Share & Trends," 2022.
[2] Fitch Solutions, "Pharmaceuticals & Biotechnology: Opportunities in Pain Management," 2023.