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
Pain	5
Healthy	5
Chronic Pain	3
Peer Review, Research	2

Condition MeSH

Condition MeSH for DURAGESIC-37
Intervention	Trials
Pain, Postoperative	3
Chronic Pain	3
Mucositis	2
Low Back Pain	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
Recruiting	2
Terminated	2

Clinical Trial Sponsors for DURAGESIC-37

Sponsor Name

Sponsor Name for DURAGESIC-37
Sponsor	Trials
Khon Kaen University	2
National Cancer Institute (NCI)	2
Mylan Pharmaceuticals	2

Sponsor Type

Sponsor Type for DURAGESIC-37
Sponsor	Trials
Other	17
Industry	12
NIH	2

DURAGESIC-37: Clinical Trials Update, Market Analysis, and Projection

Last updated: May 6, 2026

What is DURAGESIC-37 and what does “-37” indicate in product strategy?

DURAGESIC-37 is a fentanyl transdermal system strength marketed as durable fentanyl delivery via skin patches. The “37” designation aligns with the 37.5 mcg/h patch strength used in the DURAGESIC lineup (a fentanyl base transdermal patch delivering fentanyl over ~72 hours per application) (see product/labeling references for patch strengths and dosing intervals) [1], [2].

Core product attributes used in market modeling

• Route: transdermal
• Mechanism: opioid agonist (fentanyl) for chronic pain requiring around-the-clock opioid treatment (labeling standard for fentanyl patches) [1], [2]
• Dosing interval: replacement every 72 hours (standard fentanyl patch regimen) [1], [2]

What clinical trial landscape applies to DURAGESIC-37 specifically?

Duragesic transdermal fentanyl has a long history, with the main clinical evidence base established earlier than the typical profile for ongoing “new” registrational trials. For “DURAGESIC-37” (37.5 mcg/h), clinical development is typically integrated into the broader fentanyl patch program rather than supported by a distinct modern RCT pipeline by strength.

Current evidence structure in practice

• Older registrational data supports the fentanyl transdermal patch platform across strengths, including the 37.5 mcg/h regimen.
• Post-approval work typically shifts to: labeling updates, safety refinements, real-world utilization, and pharmacokinetic (PK) or formulation-performance studies rather than large efficacy RCTs.

What is actionable today

The only “clinical trials update” that is decision-grade for DURAGESIC-37 must be grounded in:

1. strength-specific trials, or
2. platform trials that include the 37.5 mcg/h strength in dose-ranging arms, or
3. regulator/label documents that explicitly define dosing equivalence and safety guidance for that strength.

Without a strength-specific trial registry extract in the provided prompt, the only defensible, decision-grade clinical “update” is the regulatory and label-defined clinical use framework (see sections on dosing conversion and safety constraints).

How do regulators define clinical use for fentanyl 37.5 mcg/h patches?

Labeling for fentanyl transdermal systems sets strict patient selection and conversion rules.

Patient selection and opioid-naïve constraints

Fentanyl patches carry high-risk opioid guidance, including:

• Not indicated for opioid-naïve patients in standard labeling frameworks due to risk of respiratory depression [1], [2]
• Use is restricted to patients who already tolerate opioids, with dosing conversion from prior opioid regimens required before patch initiation [1], [2]

Dosing and conversion

The 37.5 mcg/h patch strength fits into the dose conversion charts that map total daily opioid exposure to patch strength, using:

• patch replacement every 72 hours [1], [2]
• titration based on pain control and tolerability

Key safety warnings shaping clinical outcomes

Labeling highlights safety constraints that directly affect market adoption and prescribing behavior:

• Respiratory depression risk, especially in opioid-naïve or improperly converted patients [1], [2]
• Opioid use disorder and misuse risk [1], [2]
• Serious adverse events including overdose with inappropriate use [1], [2]
• Drug interactions (CYP3A4 inhibitors/inducers in standard fentanyl labeling context) [1], [2]

How is DURAGESIC-37 positioned versus alternative fentanyl formulations?

Market dynamics for transdermal fentanyl are driven by:

• patient preference (non-oral dosing)
• steady-state delivery (vs short-acting opioids)
• insurer coverage rules for chronic pain opioid therapy

Competitive set commonly modeled in chronic pain

• Other transdermal fentanyl strengths/systems (same branded platform)
• Generic fentanyl transdermal patches where available in the market
• Other long-acting opioids (e.g., ER morphine, ER oxycodone, methadone in some markets)
• Buprenorphine transdermal systems in some reimbursement environments

Because DURAGESIC-37 is a strength, its “competition” is usually the therapeutic alternative class plus within-class switching among fentanyl patch strengths.

What is the market opportunity and where is demand likely to concentrate?

A strength-level market forecast for 37.5 mcg/h requires an assumptions chain (patch penetration, mix across strengths, and substitution rates across brands/generics). Since the prompt provides no numeric source for strength share, the decision-grade projection must use label-anchored and structurally stable demand drivers rather than invented precision.

Demand drivers

1. Chronic cancer pain and chronic non-cancer pain populations treated with stable opioid regimens
2. Prescriber preference for transdermal delivery in patients with adherence barriers to oral dosing
3. Formulary and coverage policies that favor long-acting opioids under controlled criteria

Constraints shaping demand

1. Strict opioid-exposure requirements and conversion rules in labeling reduce the addressable population (opioid-naïve exclusions and conversion errors) [1], [2]
2. High adverse-event scrutiny for opioids increases monitoring costs and limits rapid titration [1], [2]

How does patent and regulatory status change pricing power for DURAGESIC-37?

DURAGESIC (fentanyl patch) is a mature product class in many jurisdictions. The market effect is that:

• brand pricing power typically erodes with generic entry (strength mix shifts toward lower-cost alternatives)
• reimbursement becomes the key determinant of volume, not clinical superiority

In the absence of explicit patent-expiry and litigation timelines for the specific “DURAGESIC-37” strength in the prompt, the forecast should not treat DURAGESIC-37 as having standalone patent protection. Strength-specific pricing power is usually tied to the underlying fentanyl patch product IP/regulatory history, not the mcg/h number alone.

Market projection framework for DURAGESIC-37 (37.5 mcg/h): base-case structure

A strength-level projection should be modeled as:

Sales (strength 37.5 mcg/h) = Total long-acting transdermal fentanyl patch market × Strength mix × Brand share × Net price

Where each component is influenced by:

• Strength mix: titration steps typically move patients among strengths based on opioid conversion and pain response
• Brand share: depends on generic penetration and formulary position
• Net price: affected by rebates, tender dynamics, and payer rules

Strength mix logic

In chronic pain titration, patients commonly start at lower effective long-acting doses and move upward if pain control is inadequate. That tends to create a distribution of patch strengths, with:

• 37.5 mcg/h often functioning as a middle strength step between lower and higher fentanyl delivery rates, depending on local conversion charts [1], [2]

Net price logic

Because fentanyl patches are established and commonly generic, net price tends to compress unless a payer network is locked to branded products.

What are the near-term commercial outcomes that matter most (2025-2028)?

For a mature opioid patch line, “near-term outcomes” hinge less on trial breakthroughs and more on:

• formulary inclusion and prior authorization criteria
• generic switching and tender cycles
• safety surveillance outcomes (dose conversion enforcement, risk management programs)

Label-driven constraints directly influence switching rates and prescriber behavior [1], [2].

Actionable heat map: where DURAGESIC-37 is most likely to win

Best-fit prescribing environments

• Patients already stabilized on opioids where 37.5 mcg/h aligns with dose conversion tables
• Settings with strong outpatient chronic pain opioid programs that control conversion accuracy
• Payers that treat transdermal long-acting opioids as a step therapy option

Worst-fit environments

• High opioid-naïve prescribing volume where eligibility screening is weak (label contraindication framework) [1], [2]
• Systems with aggressive generic substitution and restrictive branded coverage
• Regions where pharmacy tendering reduces branded market access

Key takeaways

• DURAGESIC-37 is the 37.5 mcg/h fentanyl transdermal patch strength, delivered over 72-hour intervals and positioned for opioid-tolerant patients under strict conversion and safety guidance [1], [2].
• The clinical “update” for this strength is not typically driven by new registrational trials because fentanyl patch evidence is mature; decision-grade updates come from labeling requirements that govern opioid eligibility and dose conversion [1], [2].
• The market forecast for the 37.5 mcg/h strength is best modeled as a share of the total transdermal fentanyl patch market, then split by strength mix and brand/generic share, with net pricing compressed by generic competition and payer controls.
• Commercial outcomes over the next few years depend more on formulary and substitution than on new clinical efficacy differentiation, since safety constraints and dosing rules drive real-world prescribing.

FAQs

1) Is DURAGESIC-37 intended for opioid-naïve patients?

Standard fentanyl transdermal patch labeling restricts use based on opioid tolerance and emphasizes that the patch is not indicated for opioid-naïve patients due to respiratory depression risk [1], [2].

2) How often is a 37.5 mcg/h fentanyl transdermal patch replaced?

It is replaced every 72 hours under standard dosing guidance for fentanyl transdermal systems [1], [2].

3) Does DURAGESIC-37 have strength-specific efficacy trials that drive current prescribing?

In practice, evidence is built around the fentanyl patch platform and dosing conversion framework, with the 37.5 mcg/h strength integrated into that system-level clinical basis rather than treated as a standalone innovation line.

4) What determines whether DURAGESIC-37 captures share versus other long-acting opioids?

Coverage rules, prior authorization, and substitution behavior within long-acting opioid classes, plus prescriber confidence in safe conversion and titration per labeling guidance [1], [2].

5) What safety warnings matter most for market adoption at this strength?

Respiratory depression risk from improper conversion, opioid misuse potential, and interaction-related overdose risks are the core adoption constraints that shape prescribing eligibility and payer scrutiny [1], [2].

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References (APA)

[1] Janssen-Cilag. (n.d.). Duragesic (fentanyl transdermal system) prescribing information.
[2] U.S. Food and Drug Administration. (n.d.). Duragesic (fentanyl transdermal system) label.