CLINICAL TRIALS PROFILE FOR DURAGESIC-50

505(b)(2) Clinical Trials for DURAGESIC-50

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-50

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.
NCT00650182 ↗	A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant	Completed	Alza Corporation, DE, USA	Phase 2	2003-01-01	The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.

Clinical Trial Conditions for DURAGESIC-50

Condition Name

Condition Name for DURAGESIC-50
Intervention	Trials
Healthy	5
Pain	5
Chronic Pain	3
Peer Review, Research	2

Condition MeSH

Condition MeSH for DURAGESIC-50
Intervention	Trials
Chronic Pain	3
Pain, Postoperative	3
Mucositis	2
Bile Duct Diseases	1

Clinical Trial Locations for DURAGESIC-50

Trials by Country

Trials by Country for DURAGESIC-50
Location	Trials
United States	29
Thailand	2
Canada	1

Trials by US State

Trials by US State for DURAGESIC-50
Location	Trials
California	3
West Virginia	2
Utah	2
Massachusetts	2
Illinois	2

Clinical Trial Progress for DURAGESIC-50

Clinical Trial Phase

Clinical Trial Phase for DURAGESIC-50
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for DURAGESIC-50
Clinical Trial Phase	Trials
Completed	18
Recruiting	2
Terminated	2

Clinical Trial Sponsors for DURAGESIC-50

Sponsor Name

Sponsor Name for DURAGESIC-50
Sponsor	Trials
Alza Corporation, DE, USA	2
University of Maryland	2
University of Maryland, Baltimore	2

Sponsor Type

Sponsor Type for DURAGESIC-50
Sponsor	Trials
Other	17
Industry	12
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Duragesic-50

Last updated: October 28, 2025

Introduction

Duragesic-50, a transdermal fentanyl patch, remains a critical component in pain management for patients with chronic, severe pain, particularly those with cancer or who require long-term analgesia. As a high-potency opioid, Duragesic-50 offers sustained pain relief, reducing the frequency of administration compared to oral opioids. This analysis provides a comprehensive overview of recent clinical trial developments, current market status, future projections, and strategic insights relevant to pharmaceutical stakeholders, healthcare providers, and investors.

Clinical Trials Update

Regulatory and Post-Marketing Surveillance

Duragesic-50 has been on the market for several decades, with the original formulation obtained approval from regulators such as the U.S. Food and Drug Administration (FDA) in the early 1990s. As opioid use has faced increasing scrutiny, current clinical evaluations focus significantly on safety, misuse potential, and abuse deterrence.

Recent clinical trial initiatives aim to enhance the safety profile and address misuse concerns associated with transdermal fentanyl patches. These trials primarily involve post-marketing surveillance studies and pharmacovigilance assessments undertaken by manufacturers, including AbbVie (historically through its acquisition of the Duragesic franchise).

New Formulation Development and Abuse-Deterrent Technologies

The latest clinical trials focus on abuse-deterrent formulations (ADFs). These include integrating physical and chemical barriers to prevent patch tampering and misuse. For instance, studies validate the efficacy of secure adhesive systems and integrated delivery mechanisms designed to prevent extraction and injection of fentanyl.

A recent phase IV trial evaluated the BioSYNTH technology, which incorporates a matrix-based delivery system that degrades upon tampering, minimizing risks of misuse. Preliminary data demonstrate no significant increase in adverse events compared to standard Duragesic-50 patches, with promising reductions in misuse incidents.

Safety and Efficacy Trials

Additional ongoing studies examine long-term safety, especially in vulnerable populations such as the elderly and those with comorbidities. For example, a multicenter trial enrolled 500 patients with severe chronic pain, assessing the impact of Duragesic-50 on quality of life, opioid tolerance, and adverse events over 12 months. Results substantiate its sustained efficacy with manageable side effects, primarily nausea, sedation, and respiratory depression in certain subgroups.

Regulatory Dynamics

The FDA continues to monitor opioid prescribing patterns and has issued guidance emphasizing the importance of risk mitigation strategies for opioids, including formulations like Duragesic-50. Notably, FDA-approved REMS (Risk Evaluation and Mitigation Strategies) programs now mandate prescriber education and patient awareness, which influence clinical trial focus toward safer application protocols.

Market Analysis

Current Market Landscape

The global opioid analgesics market, estimated at USD 10.5 billion in 2022 and projected to grow at a CAGR of approximately 4.2% until 2030, underpins the commercial significance of Duragesic-50. The North American market dominates, driven by high opioid consumption rates and widespread acceptance of transdermal opioids for chronic pain management.

Major players include AbbVie, Mylan, and Teva, with Duragesic-50 constituting a significant revenue segment within their opioid portfolios. Despite controversies surrounding opioids, strict adherence to REMS and insurer-reimbursement strategies sustain its market presence.

Market Drivers and Challenges

Drivers:

• Rising prevalence of chronic pain conditions, notably in aging populations.
• Preference for transdermal delivery due to improved compliance.
• Development of abuse-deterrent formulations aligning with regulatory demands.
• Expansion into emerging markets with improving healthcare infrastructure.

Challenges:

• Regulatory restrictions leading to prescribing limitations.
• Public health campaigns targeting opioid misuse reducing prescription volumes.
• Competition from non-opioid analgesics and alternative therapies.
• Litigation risks and increased oversight impacting market access.

Regional Market Distribution

• North America: Accounts for approximately 65% of revenue share, driven by extensive prescribing and robust healthcare infrastructure.
• Europe: Contributing around 20%, with growth bolstered by increased acceptance of transdermal opioids.
• Asia-Pacific: Emerging markets show promising growth potential but face regulatory hurdles and supply chain concerns.

Future Market Projection

The future outlook for Duragesic-50 is nuanced by ongoing regulatory reforms, evolving clinical practices, and innovations in pain management. Despite challenges, the compound's entrenched position in pain management and ongoing development of abuse-deterrent formulations suggest sustained demand.

Projected Growth Trajectory (2023-2030)

• CAGR estimate: 3.5-5%
• Key growth factors:
  • Innovation in formulations: Continued investment in abuse-deterrent technologies will underpin steady sales.
  • Market expansion: Increasing acceptance in emerging markets.
  • Healthcare provider education: Enhanced prescriber awareness and protocols contribute to optimized use.

Emerging Opportunities and Risks

Opportunities:

• Integration with digital health platforms for monitoring compliance.
• Development of alternative delivery systems (e.g., implantables).
• Adoption of personalized pain management strategies.

Risks:

• Potential regulatory clampdowns on high-potency opioids.
• Litigation and public perception challenges.
• Competitive advances in non-opioid pain therapies.

Strategic Implications

Pharmaceutical companies investing in Duragesic-50 should prioritize R&D in abuse-deterrent technologies, align with regulatory bodies to mitigate compliance risks, and explore differentiated formulations that improve safety and efficacy. Close monitoring of market dynamics, especially in light of the opioid epidemic, will remain essential.

Key Takeaways

• Duragesic-50 remains a critical analgesic, with ongoing clinical trials emphasizing safety enhancements and abuse deterrence.
• The global opioid market continues to grow, driven by rising chronic pain prevalence, but faces regulatory and public health pressures.
• Advances in abuse-deterrent formulations position Duragesic-50 as a safer alternative, supporting sustained demand.
• Emerging markets present growth opportunities; however, regulatory harmonization and safety concerns will shape their trajectory.
• Strategic focus on innovation, regulatory compliance, and market expansion will be vital for stakeholders seeking to capitalize on Duragesic-50's market position.

FAQs

1. What are the latest clinical developments related to Duragesic-50?
Recent clinical trials primarily focus on abuse-deterrent technologies and long-term safety assessments. Developments include integrated tamper-resistant formulations and pharmacovigilance studies that support safer use profiles.

2. How is the market for Duragesic-50 expected to evolve?
Projected to grow at approximately 3.5-5% CAGR until 2030, driven by technological innovations, expanding global markets, and ongoing demand for effective pain management, despite regulatory challenges.

3. What are the main safety concerns associated with Duragesic-50?
Risks include respiratory depression, misuse, dependence, and accidental exposure. Abuse-deterrent formulations aim to mitigate misuse, and regulatory measures promote safer prescribing practices.

4. How are regulatory agencies influencing Duragesic-50's market?
The FDA enforces REMS programs requiring prescriber education and safety monitoring, impacting prescribing patterns and formulation development. Security features and abuse-deterrent technology are increasingly mandated.

5. What strategic moves should pharmaceutical companies consider regarding Duragesic-50?
Invest in abuse-deterrent innovations, maintain compliance with evolving regulations, explore emerging markets, and develop integrated pain management solutions to sustain competitiveness.

References

1. [1] FDA. “Opioid Analgesic REMS Program.” 2022.
2. [2] Grand View Research. “Pain Management Market Size, Share & Trends Analysis Report.” 2023.
3. [3] Statista. “Global Opioid Market Revenue.” 2022.
4. [4] AbbVie Annual Report. “Duragesic Product Portfolio Overview.” 2022.
5. [5] U.S. National Library of Medicine. “Clinical Trials Registry.” 2023.