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.

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
Hypotension	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
Florida	2
Maryland	2
West Virginia	2
Utah	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
National Cancer Institute (NCI)	2
Mylan Pharmaceuticals	2
Food and Drug Administration (FDA)	2

Sponsor Type

Sponsor Type for Duragesic-12
Sponsor	Trials
Other	17
Industry	12
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Duragesic-12

Last updated: January 27, 2026

Summary

Duragesic-12 (fentanyl transdermal patches), marketed under the brand Duragesic, is a potent opioid analgesic primarily used for managing severe pain. Currently, no publicly registered or ongoing clinical trials specifically targeting Duragesic-12 are evident. The broader Duragesic product line, however, continues to be part of an evolving regulatory and market landscape, influenced by shifting opioid policies and opioid crisis mitigation efforts.

Market-wise, the global transdermal fentanyl delivery system, with Duragesic as a leading product, is projected to witness moderate growth due to increasing chronic pain prevalence, aging populations, and clinical demand for non-invasive opioid delivery. Nonetheless, regulatory challenges, rising opioid scrutiny, and alternatives such as abuse-deterrent formulations (ADFs) and non-opioid therapies are shaping the product's market trajectory.

This report synthesizes available clinical trial data, regulatory updates, market size estimates, and future projections to inform stakeholders about Duragesic-12’s market dynamics and research development landscape.

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Clinical Trials Landscape for Duragesic-12

Current Clinical Trials and Research Activity

• ClinicalTrials.gov Analysis
  Extensive searches for "Duragesic" and "fentanyl transdermal patch" reveal no registered clinical trials explicitly targeting Duragesic-12 with the "phase," "interventional," or "observational" categories post-2020. The majority involve comparative efficacy, pharmacokinetics, or safety of fentanyl patches broadly, not specific to Duragesic-12.

• Purpose of Trials
  Existing studies aim to assess:

  • Pharmacokinetic profiles in special populations (e.g., renal impairment)
  • Abuse potential assessments
  • Comparative efficacy versus other opioids
  • Safety and adverse event profiles, especially in vulnerable groups

• Implication
  Ongoing clinical research appears decentralized, with no new product-specific trials. The focus seems to be on refining understanding of fentanyl patches' safety and efficacy rather than innovating Duragesic-12 specifically.

Regulatory Developments and Post-Market Surveillance

• FDA and EMA Monitoring
  The FDA has issued safety communications regarding risks of misuse, overdose, and accidental exposure associated with fentanyl patches, leading to regulatory pressures on formulations and prescribing practices.
  The EMA has similarly emphasized risk mitigation, including risk management plans (RMPs) for fentanyl products.

• New Formulations and Abuse-Deterrent Technologies
  While specific to other fentanyl products, recent innovations include abuse-deterrent formulations, which might influence the future of Duragesic-12, though no explicit trials or approvals for branded Duragesic patches with such features exist currently.

Summary of Clinical Trial Status

Aspect	Status	Notes
Registered clinical trials for Duragesic-12	None active or recruiting	No specific ongoing trials registered
Focus of existing research	Pharmacokinetics, safety, abuse potential	Broader fentanyl patch studies, not product-specific
Post-market surveillance	Ongoing (safety communications)	Emphasis on misuse prevention

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Market Analysis for Duragesic-12

Market Overview

• Product Class: Transdermal opioid analgesic (fentanyl patches)
• Market Players:
  • Market Leader: Johnson & Johnson (Janssen) - Duragesic
  • Other formulations: Abstral, Actiq, and novel bypasses with abuse-deterrent features
• Global Market Size (2022): Estimated at approximately $860 million,000 with North America accounting for over 70% share (per IQVIA, 2022).

Market Drivers

Driver	Details
Chronic Pain Prevalence	Growing global burden of chronic and cancer pain
Aging Population	Increased demand for non-invasive, long-acting analgesics
Clinical Preference	Preference for transdermal over oral opioids in certain patient populations
Regulatory Environment	Policies favoring opioid safety, leading to increased product scrutiny

Market Restraints

Restraint	Details
Opioid Epidemic	Stricter prescribing guidelines, abuse concerns
Regulatory Restrictions	Tighter FDA/EMA controls restricting high-dose or misused products
Competition	Development of non-opioid pain management therapies
Abuse-Deterrent Technologies	Increased adoption reducing potential for misuse

Market Segmentation

Segment	Description	Market Share (2022)	Forecast (2023-2030)
By Geography	North America, Europe, Asia-Pacific, Rest of World	NA: 70%, EU: 20%, APAC: 8%, ROW: 2%	NA growth rate: ~2.5% CAGR; others vary
By Application	Cancer pain, chronic non-cancer pain	Cancer pain (~60%), non-cancer (~40%)	Growth driven by cancer pain management
By Formulation	Duragesic, other fentanyl patches	Duragesic: >50%	Slight decline expected due to generics and new formulations

Market Projection (2023–2030)

Year	Estimated Market Value (USD)	CAGR	Notes
2023	$920 million	-	Slight recovery post-pandemic
2025	$1.02 billion	4.5%	Increased awareness and demand
2030	$1.2 billion	4%	Market stabilization, competition, and regulation influence

Competitive Landscape

Company	Product Portfolio	Market Share	Notes
Johnson & Johnson (Janssen)	Duragesic	~50-55%	Leading market share with wide distribution network
Mylan	Generic fentanyl patches	~20%	Price-sensitive segment
Teva	Generic fentanyl patches	~10%	Focus on cost reduction
Others	Various regional players	~15-20%	Emerging markets

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Comparison with Alternative Therapies

Therapy	Advantages	Disadvantages	Market Penetration
Oral opioids	Ease of administration	Higher abuse potential	Dominant but declining due to regulation
Non-opioid analgesics	Lower abuse risk	Less effective for severe pain	Increasing, especially NSAIDs, acetaminophen
Abuse-deterrent formulations	Reduced misuse	Higher cost	Growing niche market
Non-pharmacologic therapies	No side effects	Variable efficacy	Emerging segment

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Regulatory and Policy Impact

Policy / Regulation	Impact on Duragesic-12	Source / Date
FDA REMS (Risk Evaluation & Mitigation Strategy)	Restricts prescribing and dispensing	2019 update
EMA Risk Management Plan	Mandatory safety protocols	2021
Opioid prescribing guidelines	Limits dose and duration	US CDC, 2022
Abuse deterrent mandates	Accelerate development	FDA 2021

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Deep Dive: Future Outlook and Innovations

• Emerging Technologies:

  • Development of abuse-deterrent patches with physical/chemical barriers.
  • Combination patches with non-opioid analgesics.

• Pipeline Products:

  • Generic versions with abuse-deterrent features are under development but face regulatory hurdles.
  • Biosimilar or alternative delivery systems could impact Duragesic's dominance.

• Potential Disruption Factors:

  • Legal actions against opioid manufacturers and prescribers.
  • Transition to non-opioid alternatives like cannabinoids, nerve modulation.

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Key Takeaways

• No active or recent clinical trials specifically targeted at Duragesic-12 are registered, indicating limited research innovation directly associated with this formulation currently.
• Market growth remains steady but constrained by regulatory oversight, the opioid crisis, and rising competition from abuse-deterrent and non-opioid therapies.
• The global fentanyl patch market is projected to grow at a compounded rate of approximately 4% through 2030, driven by chronic pain management needs.
• Duragesic's dominant position faces potential challenges from newer formulations with abuse-deterrent features and evolving treatment guidelines.
• Strategic focus for stakeholders should include regulatory compliance, monitoring of innovations in abuse deterrence, and diversification toward alternative pain management treatments.

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FAQs

1. Are there any ongoing clinical trials specifically for Duragesic-12?
No registered or known ongoing clinical trials specifically targeting Duragesic-12 are documented. Most research focuses on the broader fentanyl transdermal patch class.

2. How does regulatory policy influence the Duragesic market?
Regulatory agencies like the FDA and EMA have implemented strict risk mitigation strategies, including REMS programs and safety communications, affecting prescribing patterns and encouraging development of abuse-deterrent formulations.

3. What are the main competitors to Duragesic in the fentanyl patch market?
Generic fentanyl patches from companies such as Mylan and Teva, as well as emerging abuse-deterrent formulations, are key competitors. Non-patch opioids and non-opioid analgesics also compete indirectly.

4. How might future innovations impact Duragesic-12?
Innovations such as abuse-deterrent technologies and combination formulations could displace traditional Duragesic patches if regulatory approvals are obtained and adoption occurs.

5. What is the projected growth outlook for the fentanyl patch market?
Between 2023 and 2030, the market is expected to grow at a CAGR of approximately 4%, driven by increasing global chronic pain prevalence, albeit tempered by regulatory and social factors.

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References

1. IQVIA (2022). Global Transdermal Fentanyl Market Data.
2. FDA (2019). REMS Program for Opioid Analgesics.
3. EMA (2021). Risk Management Plan for Fentanyl Patches.
4. CDC (2022). Opioid Prescribing Guidelines.
5. ClinicalTrials.gov (2023). Search Results for Fentanyl Transdermal Patches.