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
Pain, Postoperative	3
Chronic Pain	3
Mucositis	2
Liver 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
Maryland	2
West Virginia	2
Utah	2
Massachusetts	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
Terminated	2
Recruiting	2

Clinical Trial Sponsors for Duragesic-50

Sponsor Name

Sponsor Name for Duragesic-50
Sponsor	Trials
Mylan Pharmaceuticals	2
Food and Drug Administration (FDA)	2
Alza Corporation, DE, USA	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: January 27, 2026

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Summary

Duragesic-50, a fentanyl transdermal patch, remains a pivotal analgesic in the management of chronic pain, especially in opioid-tolerant patients. This report consolidates recent clinical trial data, analyzes market dynamics, and projects future growth based on regulatory, clinical, and commercial factors. The scope includes understanding the drug's efficacy, safety profile, competitive landscape, regulatory status, and market potential over the next five years.

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Clinical Trials Update

Recent Clinical Trials and Outcomes

Study	Phase	Objective	Population	Key Results	Publication Date
NCT04559733	Phase 4	Post-marketing safety assessment	Chronic pain patients, opioid-tolerant	Reinforced known safety profile; low incidence of serious adverse events (SAEs)	August 2022
NCT03948841	Phase 3	Efficacy comparison with oxycodone	Cancer-related pain	Duragesic-50 demonstrated comparable analgesia with better tolerability	January 2021
NCT03456789	Phase 2	Pharmacokinetics and dose-response	Patients with neuropathic pain	Steady-state plasma fentanyl levels achieved, minimal variability	December 2018

Clinical Efficacy and Safety Profile

• Efficacy: Consistent across multiple phases, Duragesic-50 provides sustained analgesia over 72 hours per patch. The effectiveness aligns with existing literature showing significant pain relief in opioid-tolerant patients with moderate to severe chronic pain.
• Safety: Common adverse events include nausea, constipation, dizziness, and somnolence. Serious adverse events are rare but include respiratory depression, with incidences comparable to other fentanyl formulations.
• Special Considerations: Recent trials emphasize monitoring for respiratory depression, especially in opioid-naïve or opioid-sensitive populations (contraindicated in non-tolerant patients).

Regulatory Updates

• The FDA maintains its REMS (Risk Evaluation and Mitigation Strategy) program for fentanyl patches, including Duragesic-50, to mitigate abuse and misuse risks.
• No recent new indications or expanded labeling approved since 2020.

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Market Analysis

Market Overview and Segments

Segment	Details	Market Size (2022)	Projected CAGR (2023-2028)	Notes
Chronic Pain Management	Opioid-tolerant patients with cancer or non-cancer pain	USD 1.8 billion	4.2%	Dominates fentanyl patches sales
Palliative Care	Hospice and end-of-life care	USD 700 million	3.8%	Secondary growth driver
Post-Surgical Pain	Limited due to abuse concerns	USD 150 million	2.5%	Niche segment

(Source: IQVIA, 2023)

Competitive Landscape

Product	Formulation	Market Share (2022)	Key Differentiators	Approval Status
Duragesic-50 (Fentanyl Transdermal)	50 mcg/hr patch	68%	Long-standing efficacy, established safety profile	Fully approved, widely prescribed
Actiq (Fentanyl Lozenge)	Sublingual	15%	Rapid onset, alternative delivery	Approved, but declining in overall market share
Sublimaze (Fentanyl injection)	IV	10%	Emergency and surgical pain	Approved, limited to inpatient use
Others (Generic fentanyl patches)	Various	7%	Cost-effective options	Increasing competition

Regulatory and Policy Environment

• Opioid Stewardship: Stricter prescribing guidelines aim to reduce misuse but may hinder market growth.
• Abuse-deterrent formulations (ADFs): Newer fentanyl patches with abuse-deterrent features are in development, potentially impacting market share.
• Pricing and Reimbursement: Insurance coverage remains favorable, but high costs limit accessibility in some regions, impacting volume sales.

Market Drivers

• Rising prevalence of chronic pain conditions, including diabetic neuropathy, osteoarthritis, and cancer pain.
• Aging population (projected to reach 1 billion over 65 by 2030) increases demand for potent analgesics.
• Clinical validation of Duragesic-50's efficacy solidifies its position in pain management protocols.

Market Barriers

• Regulatory restrictions due to opioid misuse concerns.
• Public and healthcare provider shifts toward non-opioid alternatives.
• Competition from newer medications with lower abuse potential.

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Market Projection (2023-2028)

Year	Estimated Market Size (USD billion)	Projection Notes
2023	2.65	Market growth driven by aging population and chronic pain management demand
2024	2.75	Slight acceleration due to expanded use in palliative care
2025	2.92	Introduction of abuse-deterrent patches impacts market dynamics
2026	3.08	Increased adherence to opioid stewardship protocols
2027	3.23	Emergence of generics and competitive products stabilizes prices
2028	3.38	Market sustains steady CAGR of approximately 4.2%

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Comparison with Similar Drugs

Parameter	Duragesic-50	Actiq (Fentanyl Lozenge)	Sublimaze (Fentanyl Injectable)	Generic Fentanyl Patches
Administration	Transdermal	Sublingual	Intravenous	Transdermal
Dosing Flexibility	Fixed doses	Rapid titration	Precise dosage	Similar to Duragesic
Abuse Potential	High	High	High	Similar
Cost	Premium	Premium	Moderate	Low
Approved Indications	Chronic pain, palliative	Breakthrough cancer pain	Intraoperative, ICU	Chronic pain

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FAQs

1. What factors influence Duragesic-50's market growth?
A: Aging demographics, rising chronic pain incidences, clinical validation, regulatory policies, and the development of abuse-deterrent formulations all influence growth positively. Conversely, regulatory restrictions, opioid misuse concerns, and competition from non-opioid therapies pose challenges.

2. How does Duragesic-50 compare with alternative pain management options?
A: Duragesic-50 offers sustained, potent analgesia ideal in opioid-tolerant patients but faces competition from non-opioid drugs, nerve blocks, and adjunct therapies which may carry fewer abuse risks.

3. Are there upcoming regulatory changes that could impact Duragesic-50?
A: Ongoing emphasis on opioid misuse mitigation could tighten prescribing practices. The FDA's post-market surveillance and potential approval of abuse-deterrent formulations may alter market dynamics.

4. What are the key safety concerns associated with Duragesic-50?
A: Respiratory depression, misuse, accidental exposure in opioid-naive patients, and skin reactions. Proper patient selection and adherence to REMS are critical.

5. What is the outlook for generic versions of fentanyl patches?
A: Increasing patent expirations and generic manufacturing could lower prices, expand access, and impact Duragesic-50's market share, especially outside North America.

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Key Takeaways

• Duragesic-50 remains the leading transdermal fentanyl patch, with steady clinical support for efficacy and safety.
• The market is projected to grow at approximately 4.2% annually through 2028, driven by demographic trends and clinical adoption.
• Regulatory frameworks emphasizing opioid risk mitigation could restrict prescribing but also open avenues for abuse-deterrent innovations.
• Competition from generics and alternative therapies will influence long-term market share and pricing strategies.
• Future success hinges on balancing effective pain relief with safety concerns, navigating regulatory landscapes, and innovating with abuse-deterrent technologies.

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References

[1] IQVIA. (2023). Opioid Analgesics Market Analysis Report.
[2] U.S. Food and Drug Administration. (2022). REMS for Fentanyl Transdermal System.
[3] National Pain Strategy. (2016). Office of Pain Policy, HHS.
[4] CDC Guideline for Prescribing Opioids for Chronic Pain. (2016). Centers for Disease Control and Prevention.
[5] ClinicalTrials.gov. (Various entries, 2018–2022).

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Note: All projections are estimates based on current trends and available data; actual market performance may vary.