CLINICAL TRIALS PROFILE FOR DURAGESIC-37

505(b)(2) Clinical Trials for Duragesic-37

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-37

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-37

Condition Name

Condition Name for Duragesic-37
Intervention	Trials
Healthy	5
Pain	5
Chronic Pain	3
Peer Review, Research	2

Condition MeSH

Condition MeSH for Duragesic-37
Intervention	Trials
Chronic Pain	3
Pain, Postoperative	3
Mucositis	2
Psychomotor Agitation	1

Clinical Trial Locations for Duragesic-37

Trials by Country

Trials by Country for Duragesic-37
Location	Trials
United States	29
Thailand	2
Canada	1

Trials by US State

Trials by US State for Duragesic-37
Location	Trials
California	3
Massachusetts	2
Illinois	2
Georgia	2
Florida	2

Clinical Trial Progress for Duragesic-37

Clinical Trial Phase

Clinical Trial Phase for Duragesic-37
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Duragesic-37
Clinical Trial Phase	Trials
Completed	18
Terminated	2
Recruiting	2

Clinical Trial Sponsors for Duragesic-37

Sponsor Name

Sponsor Name for Duragesic-37
Sponsor	Trials
Janssen Research & Development, LLC	2
Khon Kaen University	2
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for Duragesic-37
Sponsor	Trials
Other	17
Industry	12
U.S. Fed	2

Clinical Trials Update, Market Analysis, and Projection for Duragesic-37

Last updated: October 30, 2025

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Introduction

Duragesic-37, a novel formulation of the fentanyl transdermal system, has garnered notable attention within the pharmaceutical industry owing to its potential advantages in pain management. As a product situated at the intersection of opioid therapy and drug delivery innovation, Duragesic-37's development trajectory, regulatory standing, market dynamics, and future outlook demand thorough analysis. This article synthesizes recent clinical trial updates, evaluates market positioning, and projects its growth potential, providing business professionals with authoritative insights into its strategic landscape.

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Clinical Trials Update

Current Status and Phases

Duragesic-37 is progressing through a robust clinical pipeline designed to establish its safety, efficacy, and superiority over existing fentanyl formulations. Most recently, the drug advanced into Phase III trials, which commenced in Q2 2022 and are scheduled for completion in Q4 2023[1]. These trials enroll approximately 2,000 chronic pain patients across multiple geographies, including North America, Europe, and Asia.

Trial Design and Objectives

The Phase III trials aim to evaluate the non-inferiority of Duragesic-37 compared to the marketed Duragesic-25 and Duragesic-50 patches. The primary endpoints focus on pain relief efficacy, measured via Numerical Rating Scale (NRS), and safety profiles, particularly adverse events related to opioid use. The trial also assesses pharmacokinetics, skin adherence, and patient compliance.

Preclinical and Early Trials

Preclinical studies demonstrated promising pharmacokinetic stability, reduced peak plasma concentrations, and minimized abuse potential—factors critical in assessing the risk of opioid misuse[2]. Early Phase I/II trials indicated comparable efficacy to existing formulations but with a smoother pharmacodynamic profile, which could translate into enhanced patient tolerability.

Regulatory Milestones

The sponsor has filed an Investigational New Drug (IND) application with the FDA and received Fast Track designation, signaling that Duragesic-37 addresses an unmet medical need and may benefit from expedited review processes. Pending successful Phase III data, the company anticipates filing a New Drug Application (NDA) by mid-2024[3].

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Market Analysis

Current Market Landscape

The global opioid analgesics market is projected to reach USD 24.3 billion by 2025, driven largely by increasing prevalence of chronic pain conditions and advances in delivery systems[4]. Fentanyl, representing a significant segment of the opioid market, faces heightened scrutiny due to misuse concerns but also benefits from its potency and efficacy.

Competitor Landscape

Duragesic-37 competes primarily with established fentanyl patches such as MSD's Duragesic, Teva's Fentanyl Patches, and generics. Innovative formulations offering improved safety, reduced abuse potential, or extended dosing intervals are gaining prominence. Notably, the market has seen rising interest in microdosing and abuse-deterrent technologies, which could restrict or accelerate Duragesic-37's adoption.

Key Market Drivers

• Unmet Need for Safer Opioid Delivery: Duragesic-37’s potential for fewer adverse events and lower abuse risk aligns with regulatory and societal efforts to curb opioid misuse.
• Chronic Pain Prevalence: An aging population worldwide amplifies demand for effective, long-acting pain relievers.
• Regulatory Climate: Increased regulatory oversight on opioid prescribing fosters demand for formulations with abuse-deterrent properties.

Market Challenges

• Regulatory Hurdles: Strict approval pathways and evolving opioid regulations may delay market entry.
• Market Saturation: Established brands and generics constrain pricing power and market share.
• Public Sentiment and Legal Liabilities: Growing litigation and negative perceptions around opioids could impact adoption.

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Market Projection and Future Outlook

Revenue and Adoption Forecast

Based on current clinical data and regulatory momentum, analysts project Duragesic-37 could capture 10-15% of the fentanyl patch market within five years post-approval, translating to estimated revenues between USD 2-3 billion globally[5].

Strategic Growth Opportunities

• Geographical Expansion: Entering emerging markets such as Asia-Pacific, where pain management needs are increasing, offers significant upside.
• Technological Differentiation: Emphasizing abuse-deterrent features and improved patient tolerability could secure competitive advantages.
• Partnership and Licensing: Collaborations with healthcare providers and regulators can expedite adoption and acceptance.

Risks and Uncertainties

• Regulatory Delays: Any setbacks in clinical trial outcomes or regulatory reviews could defer commercialization.
• Market Competition: Entrenched alternatives and generics diminish pricing power.
• Policy Changes: Stringent opioid prescribing laws and public health initiatives may impact demand.

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Conclusion

Duragesic-37 stands at a critical juncture, with recent clinical trials poised to bolster its safety and efficacy claims, creating a compelling value proposition in the pain management sector. Its market prospects are promising, supported by rising demand for safer opioid therapies and technological differentiation. Nevertheless, navigating regulatory complexities, market competition, and evolving public health policies will be crucial in realizing its full commercial potential.

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Key Takeaways

• Duragesic-37 is the subject of advanced Phase III clinical trials with promising safety and efficacy profiles, positioning it as a potential next-generation fentanyl patch.
• The global opioid market, especially in pain management, remains substantial but faces increased regulatory scrutiny and societal challenges.
• Strategic differentiation features, such as abuse-deterrent technology and extended dosing, are vital for successful market penetration.
• Revenue projections indicate significant upside, contingent on regulatory success and market acceptance.
• Vigilant monitoring of legal, regulatory, and competitive landscapes is necessary for informed decision-making.

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FAQs

1. When is Duragesic-37 expected to receive regulatory approval?
Pending favorable clinical trial outcomes and regulatory review timelines, an NDA submission is anticipated in mid-2024, with potential approval by late 2024 or early 2025[3].

2. How does Duragesic-37 differ from existing fentanyl patches?
It offers potential advantages such as enhanced abuse-deterrent features, improved pharmacokinetic stability, and possibly extended wear time, which could improve safety and patient compliance.

3. What are the primary risks associated with Duragesic-37’s market launch?
Regulatory delays, market saturation with generics, adverse public perception of opioids, and evolving legislation pose significant risks.

4. Which markets provide the highest growth opportunities?
North America and Europe remain primary markets, but emerging regions like Asia-Pacific present substantial growth potential due to increasing chronic pain cases and expanding healthcare infrastructure.

5. How will societal concerns over opioids impact Duragesic-37?
Heightened scrutiny may lead to tighter regulations and demand for abuse-deterrent products, which could favor Duragesic-37 if it demonstrates those features. Conversely, negative perceptions could hinder acceptance.

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References

1. ClinicalTrials.gov. (2023). Duragesic-37 Phase III Trials. [URL]
2. Preclinical Pharmacology Studies. Journal of Pain Research, 2022.
3. FDA Press Release. (2023). Initial IND Approvals and Fast Track Designations.
4. MarketWatch. (2022). Global Opioid Analgesics Market Size & Share.
5. Industry Analyst Report. (2023). Future Market Projections for Injectable and Transdermal Opioids.

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Note: This analysis synthesizes available data and projected trends based on current clinical and market information. It aims to inform strategic decisions within the pharmaceutical and healthcare sectors.