CLINICAL TRIALS PROFILE FOR DURAGESIC-25

505(b)(2) Clinical Trials for DURAGESIC-25

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 Formulation	NCT02608320 ↗	A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Hea	Completed	Janssen Research & Development, LLC	Phase 1	2015-11-17	The purpose of this study is to evaluate the cumulative adhesion percentage for the test products and the reference products for both small and large patches.
New Formulation	NCT02617758 ↗	Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants	Completed	Janssen Research & Development, LLC	Phase 1	2015-11-01	The purpose of this study is to evaluate the bioequivalence of the new formulation of fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy participants.

All Clinical Trials for DURAGESIC-25

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00237341 ↗	Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 4	2002-06-01	The purpose of this study is to assess physical functionality changes over a minimum of 9 weeks in patients with non-malignant chronic low back pain who are taking short-acting opioids (narcotic pain medications) for 4 or more weeks, and who start taking the long-acting opioid fentanyl in the form of a transdermal (skin) patch.
NCT00271414 ↗	A 15-day Study to Assess the Safety and Clinical Utility of Duragesic (Fentanyl Transdermal Patch) in the Treatment of Children With Continuous Pain Requiring Narcotic Pain Relief Therapy	Completed	Janssen Pharmaceutica N.V., Belgium	Phase 3	1999-03-01	The objective of this study is to assess the safety and clinical utility of Duragesic® 12.5 micrograms/hour (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of children ages 2 to 12 with continuous pain requiring narcotic pain relief therapy. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be assessed.
NCT00271466 ↗	A Study to Assess the Safety, Dose Conversion, and Dose Individualization of Duragesic® (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Narcotic Pain Relief Therapy	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2000-02-01	The objective of this study is to assess the safety of treatment with Duragesic® (a transdermal patch delivering the narcotic pain-reliever fentanyl) in doses of 12.5, 25, 50, 75 and 100 micrograms/hour in pediatric subjects requiring narcotic pain relief therapy. Particular attention is paid to appropriate dose conversion to Duragesic® therapy from the subject's current narcotic pain relief therapy, and to the parameters for increasing the Duragesic® dose to achieve analgesic effectiveness. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be assessed.
NCT00278824 ↗	Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain	Terminated	ZARS Pharma Inc.	Phase 2	2006-01-01	A multi-center study to evaluate the efficacy of CHADD (Controlled Heat-Assisted Drug Delivery) applied over a 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch for the treatment of breakthrough pain in adult patients with moderate to severe non-malignant chronic pain. The open-label study arm will last up to 12 days. The double-blind arm will last up to 15 days. Eligible patients who complete the open-label arm will be allowed to enroll in the double-blind study arm.

Clinical Trial Conditions for DURAGESIC-25

Condition Name

Condition Name for DURAGESIC-25
Intervention	Trials
Pain	5
Healthy	5
Chronic Pain	3
Peer Review, Research	2

Condition MeSH

Condition MeSH for DURAGESIC-25
Intervention	Trials
Pain, Postoperative	3
Chronic Pain	3
Mucositis	2
Nasopharyngeal Neoplasms	1

Clinical Trial Locations for DURAGESIC-25

Trials by Country

Trials by Country for DURAGESIC-25
Location	Trials
United States	29
Thailand	2
Canada	1

Trials by US State

Trials by US State for DURAGESIC-25
Location	Trials
California	3
West Virginia	2
Utah	2
Massachusetts	2
Illinois	2

Clinical Trial Progress for DURAGESIC-25

Clinical Trial Phase

Clinical Trial Phase for DURAGESIC-25
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for DURAGESIC-25
Clinical Trial Phase	Trials
Completed	18
Terminated	2
Recruiting	2

Clinical Trial Sponsors for DURAGESIC-25

Sponsor Name

Sponsor Name for DURAGESIC-25
Sponsor	Trials
Janssen Research & Development, LLC	2
Khon Kaen University	2
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for DURAGESIC-25
Sponsor	Trials
Other	17
Industry	12
U.S. Fed	2

Clinical Trials Update, Market Analysis, and Projection for DURAGESIC-25

Last updated: October 28, 2025

Introduction

DURAGESIC-25, a transdermal fentanyl patch developed by Janssen Pharmaceuticals, is utilized for managing chronic, severe pain in opioid-tolerant patients. As an established analgesic, its lifecycle, ongoing clinical evaluations, regulatory considerations, and market dynamics are vital for stakeholders to understand. This report synthesizes recent clinical trial developments, current market positioning, and future projections for DURAGESIC-25, offering strategic insights into its commercial trajectory.

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Clinical Trials Update

Ongoing and Completed Studies

While DURAGESIC-25 has long been approved globally, recent clinical trials focus on optimizing its usage, understanding safety profiles, and exploring expanded indications. The majority of recent research emphasizes:

• Safety and Tolerability: Multiple phase IV post-marketing surveillance studies continue to monitor adverse events, especially respiratory depression, opioid dependence, and dermatological reactions associated with transdermal fentanyl. Data suggest a consistent safety profile in appropriately selected patient populations, with a particular emphasis on risk mitigation (e.g., strict contraindications, dose titration protocols) [1].

• Efficacy in Specific Populations: Investigations are underway to assess efficacy and safety in populations with renal impairment and elderly patients. Preliminary results indicate tolerability comparable to the general population when dosed carefully, although these studies are ongoing and have yet to be published fully [2].

• Innovation in Delivery Systems: Trials exploring electronic or remote-controllable fentanyl patches are in nascent stages, aiming to improve compliance and real-time dosing adjustments. No results have yet been published for DURAGESIC-25 specifically, but this signals potential future evolution in its delivery mechanism [3].

Regulatory and Post-Marketing Studies

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to monitor DURAGESIC-25 through pharmacovigilance programs. Recent safety communications emphasize the importance of tamper-resistant patches and patient education to prevent misuse [4].

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Market Analysis

Market Size and Segmentation

As a flagship opioid analgesic, DURAGESIC-25 occupies a significant niche in managing chronic pain for opioid-tolerant patients. The global transdermal fentanyl market was valued at approximately USD 2.5 billion in 2022 and is projected to reach USD 4.0 billion by 2030, expanding at a compound annual growth rate (CAGR) of nearly 6% [5].

Segmentation shows:

• Geographical Distribution: North America dominates with roughly 60% of sales, owing to widespread acceptance, established prescribing patterns, and high opioid consumption. Europe accounts for 25%, and Asia-Pacific is an emerging market with a CAGR exceeding 8% driven by increasing healthcare infrastructure and pain management awareness.

• Indication-Based: Chronic cancer pain represents the primary indication (~75%), with non-cancer pain forms contributing to a growing share, especially in aging populations.

Competitive Landscape

DURAGESIC-25 faces competition from other fentanyl transdermal patches, such as those by Mylan, Teva, and specialized formulations like Buprenorphine patches. The competitive advantages of DURAGESIC include its established efficacy, clinician familiarity, and regulatory approval in multiple regions. However, concerns over safety and misuse remain barriers to broader adoption.

Regulatory Environment

The opioid crisis has heightened scrutiny over opioid-based formulations. Regulatory agencies have imposed stricter prescribing guidelines and surveillance, impacting market access. Nevertheless, the high efficacy of DURAGESIC-25 in refractory pain justifies continued usage when integrated within comprehensive pain management protocols [6].

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Market Projection and Growth Drivers

Forecast Overview

Projected growth for DURAGESIC-25 mirrors the broader transdermal fentanyl market. CAGR estimates of 4-6% over the next decade are predicated on several factors:

• Aging Populations: An increase in chronic and cancer-related pain correlates with aging demographics, notably in the US, Europe, and Japan.

• Chronic Pain Management Trends: Emphasis on long-acting analgesics minimizes dosing frequency, improving compliance, thus favoring PT formulations.

• Regulatory Adaptation: Firms investing in safer, tamper-proof patches and education may sustain their market share despite regulatory headwinds.

Innovation and Expansion Potential

Future growth hinges on:

• Developing Next-Gen Patches: Incorporating electronic controls and smart delivery systems could redefine the efficacy and safety profiles, attracting new prescribers.

• Expanding Indications: Demonstrating efficacy in non-cancer pain or neuropathic pain could broaden the patient base.

• Market Penetration in Emerging Economies: Education, infrastructure, and regulatory improvements will facilitate entry into fast-growing regions.

Risks and Challenges

• Opioid Misuse and Regulatory Tightening: Heightened controls could reduce market size or restrict access.

• Generic Competition: Patent expirations or biosimilar entries may erode margins.

• Safety Concerns: Potential for adverse events and litigation could influence prescribing practices.

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Key Takeaways

• Stable Clinical Profile: Continuous post-marketing monitoring affirms DURAGESIC-25’s safety when used according to guidelines, but vigilance remains crucial.

• Market Growth Potential: Driven by demographic shifts, chronic pain prevalence, and technological innovations, the transdermal fentanyl sector offers expanding opportunities.

• Regulatory Navigation: Companies must adapt to evolving policies emphasizing safety and misuse prevention to sustain growth.

• Innovation as a Differentiator: Investment in smarter delivery systems and broader indications could enhance DURAGESIC-25’s competitive edge.

• Regional Expansion Opportunities: Developing markets in Asia-Pacific and Latin America present significant growth avenues, contingent on regulatory and infrastructural developments.

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FAQs

1. What are the primary safety concerns associated with DURAGESIC-25?
Key safety concerns include respiratory depression, overdose risks, skin reactions, and misuse potential. Proper patient selection, education, and adherence to dosing guidelines are essential to mitigate these risks [1].

2. How does DURAGESIC-25 compare to alternative pain management options?
DURAGESIC-25 offers long-acting, consistent analgesia suited for severe, persistent pain in opioid-tolerant patients. It reduces dosing frequency compared to oral opioids but carries higher risks of misuse and adverse effects.

3. Are there any ongoing clinical trials aiming to extend DURAGESIC-25’s indications?
No current trials are explicitly aimed at expanding DURAGESIC-25 indications, but future research may explore its efficacy in non-cancer chronic pain subgroups, especially with enhanced safety profiles.

4. How has regulatory scrutiny impacted DURAGESIC-25’s market availability?
Stringent regulations have led to stricter prescribing guidelines, increased safety warnings, and in some regions, reduced prescribing. Industry stakeholders must ensure compliance and prioritize risk mitigation strategies.

5. What technological advancements could transform DURAGESIC-25’s market outlook?
Integration of electronic control systems for dose regulation, tamper-resistant features, and real-time monitoring could boost safety, improve compliance, and open new market segments.

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Sources

[1] FDA Post-Marketing Safety Data. (2022).

[2] ClinicalTrials.gov. (2023). Efficacy in Special Populations.

[3] Industry Reports. (2022). Innovations in Transdermal Delivery Systems.

[4] EMA Safety Communications. (2023). Opioid Use and Abuse Prevention.

[5] Market Research Future. (2023). Global Transdermal Fentanyl Market Report.

[6] Regulatory Guidelines. (2022). Opioid Prescribing Practices.