CLINICAL TRIALS PROFILE FOR DURAGESIC-100

505(b)(2) Clinical Trials for Duragesic-100

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-100

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-100

Condition Name

Condition Name for Duragesic-100
Intervention	Trials
Pain	5
Healthy	5
Chronic Pain	3
Peer Review, Research	2

Condition MeSH

Condition MeSH for Duragesic-100
Intervention	Trials
Pain, Postoperative	3
Chronic Pain	3
Mucositis	2
Nasopharyngeal Neoplasms	1

Clinical Trial Locations for Duragesic-100

Trials by Country

Trials by Country for Duragesic-100
Location	Trials
United States	29
Thailand	2
Canada	1

Trials by US State

Trials by US State for Duragesic-100
Location	Trials
California	3
Massachusetts	2
Illinois	2
Georgia	2
Florida	2

Clinical Trial Progress for Duragesic-100

Clinical Trial Phase

Clinical Trial Phase for Duragesic-100
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Duragesic-100
Clinical Trial Phase	Trials
Completed	18
Recruiting	2
Terminated	2

Clinical Trial Sponsors for Duragesic-100

Sponsor Name

Sponsor Name for Duragesic-100
Sponsor	Trials
Janssen Research & Development, LLC	2
Khon Kaen University	2
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for Duragesic-100
Sponsor	Trials
Other	17
Industry	12
U.S. Fed	2

DURAGESIC-100: Clinical Trials, Market Analysis, and Projections

Introduction

DURAGESIC-100, a transdermal fentanyl system, is a potent opioid analgesic used for the management of persistent, moderate to severe chronic pain. Here, we will delve into the clinical trials, market analysis, and projections for this medication.

Clinical Trials and Safety Profile

Contraindications and Warnings

DURAGESIC-100 is contraindicated in patients who are not opioid-tolerant, as well as in the management of acute pain, post-operative pain, mild pain, and intermittent pain. The FDA has issued a black box warning highlighting these contraindications due to the risk of serious or life-threatening hypoventilation[1][2][3].

Pharmacokinetics

Clinical trials have shown that serum fentanyl concentrations increase gradually following the initial application of DURAGESIC-100, leveling off between 12 and 24 hours and remaining relatively constant for the remainder of the 72-hour application period. Peak serum concentrations generally occur between 24 and 72 hours after initial application[1][2].

Hypoventilation Risk

In clinical trials involving 357 patients with acute pain treated with DURAGESIC®, 13 patients experienced hypoventilation. This underscores the critical need for careful patient selection and monitoring, especially during the initial application period[1].

Special Populations

There is limited information on the use of DURAGESIC-100 in patients with impaired renal or hepatic function. However, it is known that fentanyl is metabolized primarily via the cytochrome P450 3A4 isoenzyme system and mostly eliminated in urine, suggesting caution in these patient groups[2].

Market Analysis

Market Drivers

The global fentanyl transdermal patches market, including DURAGESIC-100, is driven by several key factors:

• Increase in Prevalence of Chronic Pain: The rising number of patients experiencing chronic pain, including cancer pain, is a significant driver[5].
• Prescription Rate: An increase in the prescription rate for fentanyl patches due to their efficacy in managing persistent pain contributes to market growth[5].
• Demand for OTC Alternatives: Although DURAGESIC-100 is a prescription-only medication, the overall demand for pain management solutions, including OTC options, influences the market positively[5].

Market Projections

The global fentanyl transdermal patches market is projected to expand significantly during the forecast period. North America is expected to account for a prominent share of this market due to the high prevalence of chronic pain and cancer in the region[5].

Competitive Landscape

The market for fentanyl transdermal patches has become more competitive with the expiration of patents for innovative transdermal patches, leading to the entry of generic versions. This competition is expected to drive down prices and increase accessibility[5].

Patient Population and Usage

Indications

DURAGESIC-100 is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids[1][2][3].

Dosing and Titration

The dose of DURAGESIC-100 should be titrated individually until a balance between analgesic efficacy and tolerability is achieved. The patch is available in various strengths (12.5, 25, 50, 75, and 100 mcg/h) and should be replaced every 72 hours[1][2][4].

Economic Impact

Cost and Accessibility

The expiration of patents for innovative transdermal patches has led to the availability of generic versions, which is expected to make these medications more affordable and accessible to a wider patient population[5].

Healthcare Utilization

The use of DURAGESIC-100 and similar transdermal patches can reduce the need for frequent dosing with other opioid medications, potentially lowering healthcare costs associated with pain management[5].

Future Outlook

Technological Advancements

Advancements in transdermal drug delivery systems are expected to enhance the efficacy and safety of fentanyl patches. These innovations could include improved skin permeability, more consistent drug delivery rates, and better patient compliance features[5].

Regulatory Environment

The FDA continues to monitor the use of fentanyl transdermal systems closely, issuing guidelines and warnings to ensure safe use. Any changes in regulatory policies could impact the market dynamics and patient access to these medications[1][2][3].

Key Takeaways

• Clinical Trials: DURAGESIC-100 has been shown to be effective in managing chronic pain but carries significant risks, particularly hypoventilation, which necessitates careful patient selection and monitoring.
• Market Analysis: The market for fentanyl transdermal patches is driven by the increasing prevalence of chronic pain, prescription rates, and demand for pain management solutions.
• Projections: The global market is expected to grow significantly, with North America being a major contributor.
• Patient Population: DURAGESIC-100 is indicated for opioid-tolerant patients with persistent, moderate to severe chronic pain.
• Economic Impact: The availability of generic versions and advancements in technology are expected to make these medications more accessible and cost-effective.

FAQs

What are the primary contraindications for DURAGESIC-100?

DURAGESIC-100 is contraindicated in patients who are not opioid-tolerant, as well as in the management of acute pain, post-operative pain, mild pain, and intermittent pain[1][2][3].

How often should the DURAGESIC-100 patch be replaced?

The DURAGESIC-100 patch should be replaced every 72 hours[1][2][4].

What are the peak serum concentrations of fentanyl after applying DURAGESIC-100?

Peak serum concentrations of fentanyl generally occur between 24 and 72 hours after initial application[1][2].

Can DURAGESIC-100 be used in patients with impaired renal or hepatic function?

There is limited information on the use of DURAGESIC-100 in patients with impaired renal or hepatic function, and it should be used with caution in these patient groups[2].

What are the key drivers of the global fentanyl transdermal patches market?

The key drivers include the increase in prevalence of chronic pain, rise in prescription rates, and high demand for pain management solutions[5].

Sources

1. Duragesic Label Page 1 Full Prescribing Information. FDA.
2. Duragesic Generic Name: Fentanyl. FDA.
3. States Original Petition. Texas Attorney General.
4. Durogesic DTrans 100 mcg/hr Transdermal Patch. Medicines.org.uk.
5. Fentanyl Transdermal Patches Market: Rise in patient population experiencing chronic pain to drive the market. Biospace.

Last updated: 2025-01-02