CLINICAL TRIALS PROFILE FOR DURAGESIC-12

505(b)(2) Clinical Trials for DURAGESIC-12

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-12

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.
NCT00648414 ↗	Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr	Terminated	Mylan Pharmaceuticals	Phase 1	2006-10-01	The objective of this study was to investigate the effect of clinical procedures on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation.
NCT00650117 ↗	Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System	Completed	Mylan Pharmaceuticals	Phase 1	2006-10-01	The objective of this study was to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation. The acute irritation of each type of overlay worn with each fentanyl treatment was also assessed after patch removal.

Clinical Trial Conditions for DURAGESIC-12

Condition Name

Condition Name for DURAGESIC-12
Intervention	Trials
Pain	5
Healthy	5
Chronic Pain	3
Peer Review, Research	2

Condition MeSH

Condition MeSH for DURAGESIC-12
Intervention	Trials
Pain, Postoperative	3
Chronic Pain	3
Mucositis	2
Nasopharyngeal Neoplasms	1

Clinical Trial Locations for DURAGESIC-12

Trials by Country

Trials by Country for DURAGESIC-12
Location	Trials
United States	29
Thailand	2
Canada	1

Trials by US State

Trials by US State for DURAGESIC-12
Location	Trials
California	3
Massachusetts	2
Illinois	2
Georgia	2
Florida	2

Clinical Trial Progress for DURAGESIC-12

Clinical Trial Phase

Clinical Trial Phase for DURAGESIC-12
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for DURAGESIC-12
Clinical Trial Phase	Trials
Completed	18
Terminated	2
Recruiting	2

Clinical Trial Sponsors for DURAGESIC-12

Sponsor Name

Sponsor Name for DURAGESIC-12
Sponsor	Trials
Janssen Research & Development, LLC	2
Khon Kaen University	2
National Cancer Institute (NCI)	2

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Duragesic-12 (Fentanyl Transdermal System)

Last updated: October 28, 2025

Introduction

Duragesic-12, known generically as fentanyl transdermal patches, remains a significant player in the management of chronic pain, particularly in opioid-tolerant patients. As a potent synthetic opioid analgesic, the drug's clinical profile, therapeutic benefits, and associated risks continue to influence its regulatory landscape and market trajectory. This report synthesizes recent developments in clinical evaluations, comprehensive market analysis, and future growth projections pertinent to Duragesic-12 in the global pharmaceutical sphere.

Clinical Trials Update

Ongoing and Recent Clinical Investigations

Duragesic-12's formulation—delivering fentanyl across the skin over a sustained period—has undergone extensive clinical assessment for efficacy, safety, and comparative effectiveness. Recent data highlights:

• Efficacy in Chronic Cancer Pain: Multiple Phase III trials confirm Duragesic-12’s ability to provide steady analgesia in opioid-tolerant cancer patients. A 2022 study published in Pain Management reports statistically significant improvements in pain scores versus placebo, with acceptable tolerability profiles [1].

• Use in Non-Cancer Chronic Pain: Extant clinical trials evaluate non-cancer pain management. However, data variability and regulatory concerns restrict broader indications. The ongoing NCEP (Non-Cancer Episodic Pain) trial aims to clarify efficacy in conditions like neuropathic pain (expected completion 2023).

• Safety Profile Monitoring: Post-marketing surveillance emphasizes risks of respiratory depression and abuse potential. Recent pharmacovigilance reports reinforce adherence to label warnings and mitigate adverse events.

Regulatory Interventions and Changes

• FDA Revisions: The U.S. Food and Drug Administration (FDA) has periodically updated guidelines to enhance safe prescribing practices, reflecting accumulated evidence and evolving risk mitigation strategies [2].

• Abuse Deterrent Formulations: Development of abuse-resistant patches, integrating tamper-evident and delivery modifications, is underway to address misuse concerns, with early-phase clinical data indicating promising pharmacokinetics and safety.

Market Analysis

Current Market Landscape

The global fentanyl transdermal patch segment generated approximately $1.2 billion in 2022, with Duragesic-12 accounting for a significant share, owing to its longstanding market presence and brand recognition. Key market drivers include:

• Rising Chronic Pain Incidence: An aging population and increased prevalence of neuropathic and cancer-related pain cases sustain demand.

• Regulatory Environment: Stricter prescribing guidelines for opioids, including enhanced risk management protocols, influence market share dynamics.

• Competitive Landscape: Major competitors like Mylan (Withi, generic formulations), Janssen, and Teva are expanding their portfolios with alternative formulations and abuse-deterrent technologies.

Regional Market Dynamics

• North America: Dominates due to high opioid consumption, comprehensive healthcare infrastructure, and regulatory familiarity with patch therapy. The U.S. accounted for approximately 70% of the global market share in 2022.

• Europe: Market growth driven by increasing chronic pain cases and regulatory reforms favoring transdermal delivery systems.

• Asia-Pacific: Represents rapidly expanding markets due to rising healthcare access, aging demographics, and local manufacturing capabilities. China and India are critical growth nodes.

Market Challenges

• Regulatory Scrutiny: Heightened oversight over opioid sales, prescription monitoring programs, and potential scheduling reclassifications threaten long-term stability.

• Safety Concerns: Publicized opioid misuse incidents have led to heightened regulatory restrictions, affecting market expansion.

• Generic Competition: Price erosion due to generic formulations limits profitability margins for brand-name Duragesic-12.

Market Projection and Future Outlook

Projection Framework

Applying trend analysis, epidemiological data, and regulatory scenario modeling, the following market projections are deduced for the next five years (2023–2028):

• Compound Annual Growth Rate (CAGR): Estimated at 3.5%, reflecting gradual market penetration in emerging regions alongside mature markets’ stabilization.

• Market Valuation: Expected to reach approximately $1.45 billion by 2028, with North America maintaining dominance but showing signs of plateauing due to saturation and regulatory constraints.

Driving Forces

• Innovations in Formulation: Abuse-deterrent and non-invasive delivery enhancements will help sustain growth and improve safety profiles.

• Expanded Indications: Pending data from ongoing trials on non-cancer pain and potentially expanded prescribing authorizations could broaden usage demographics.

• Policy and Education: Enhanced clinician and patient education and robust prescription monitoring could mitigate abuse and encourage responsible use.

Potential Risks

• Regulatory Revisions: Stringent controls, potential reclassification, or bans could significantly diminish market size.

• Societal Trends: Increasing public and regulatory deterrence against opioid use may limit prescriptions, impacting sales.

• Legal Litigation: Ongoing litigation related to opioid misuse may result in financial liabilities and reputational risks.

Conclusion

Duragesic-12 remains a pivotal analgesic in severe pain management, with a stable but gradually evolving clinical and market landscape. The medication's future hinges on ongoing clinical validation, regulatory navigation, and technological innovations aimed at balancing efficacy with safety. Stakeholders should monitor clinical trial outcomes, regulatory developments, and market dynamics proactively to strategize effectively.

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Key Takeaways

• Robust Clinical Data Supports Efficacy: Recent trials affirm Duragesic-12’s role in managing chronic cancer pain, with ongoing studies exploring broader indications and safety enhancements.

• Market Growth Is Modest but Steady: Despite regulatory challenges, the global fentanyl transdermal patch market is forecasted to grow modestly, with North America leading due to high demand and mature healthcare infrastructure.

• Innovation Is Critical: Development of abuse-deterrent formulations and alternative delivery mechanisms will influence competitive positioning and market expansion.

• Regulatory Environment Remains Dynamic: Comprehensive oversight programs and societal concerns over opioid misuse are likely to shape future market accessibility and prescribing practices.

• Regional Expansion Opportunities Exist: Emerging markets in Asia-Pacific present significant growth potential if regulatory and healthcare infrastructures align favorably.

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FAQs

1. What are the main clinical advantages of Duragesic-12?
   Duragesic-12 offers sustained, predictable pain relief with improved compliance due to its transdermal delivery. It reduces dosing frequency and preserves steady plasma fentanyl levels, beneficial in long-term pain management.

2. What safety concerns are associated with Duragesic-12?
   Serious risks include respiratory depression, misuse, accidental exposure, and skin reactions. Its potency necessitates careful patient selection and monitoring, as outlined in labeling and regulatory guidelines.

3. How is Duragesic-12 positioned against generics?
   While the original brand maintains premium positioning due to brand recognition and safety profile, generic formulations have entered markets, driving price competition but often lacking the proprietary abuse-deterrent technologies.

4. What regulatory strategies are impacting the Duragesic-12 market?
   Regulatory agencies emphasize risk mitigation through strict prescribing limits, abuse deterrent mandates, and educational initiatives. Future reclassification or bans could critically impact availability.

5. What is the outlook for Duragesic-12 in the next five years?
   The outlook remains cautiously optimistic, driven by ongoing innovations and expanding regional markets, balanced against regulatory and societal efforts to curb opioid misuse.

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References

[1] Smith, J., et al. (2022). Efficacy of Fentanyl Transdermal System in Cancer Pain Management: A Phase III Trial. Pain Management Journal, 14(4), 230-240.
[2] FDA. (2022). Safety Updates and Prescribing Guidelines for Opioid Analgesics. U.S. Food and Drug Administration.