CLINICAL TRIALS PROFILE FOR DURAGESIC-25

505(b)(2) Clinical Trials for DURAGESIC-25

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-25

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
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.
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.

Clinical Trial Conditions for DURAGESIC-25

Condition Name

Condition Name for DURAGESIC-25
Intervention	Trials
Healthy	5
Pain	5
Chronic Pain	3
Peer Review, Research	2

Condition MeSH

Condition MeSH for DURAGESIC-25
Intervention	Trials
Chronic Pain	3
Pain, Postoperative	3
Mucositis	2
Breakthrough Pain	1

Clinical Trial Locations for DURAGESIC-25

Trials by Country

+

−

Trials by Country for DURAGESIC-25
Location	Trials
United States	29
Thailand	2
Canada	1

Trials by US State

+

−

Trials by US State for DURAGESIC-25
Location	Trials
California	3
West Virginia	2
Utah	2
Massachusetts	2
Illinois	2

Clinical Trial Progress for DURAGESIC-25

Clinical Trial Phase

Clinical Trial Phase for DURAGESIC-25
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for DURAGESIC-25
Clinical Trial Phase	Trials
Completed	18
Terminated	2
Recruiting	2

Clinical Trial Sponsors for DURAGESIC-25

Sponsor Name

Sponsor Name for DURAGESIC-25
Sponsor	Trials
University of Maryland, Baltimore	2
Janssen Research & Development, LLC	2
Khon Kaen University	2

Sponsor Type

Sponsor Type for DURAGESIC-25
Sponsor	Trials
Other	17
Industry	12
U.S. Fed	2

Duragesic-25: Clinical Trials, Market Analysis, and Projections

Introduction

Duragesic-25, a transdermal fentanyl patch, is a potent opioid analgesic used for the management of severe chronic pain in opioid-tolerant patients. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Patient Eligibility and Opioid Tolerance

Clinical trials for Duragesic-25 have been conducted primarily in patients who are opioid-tolerant. These patients are defined as those who have been taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for at least one week[1][4][5].

Safety and Efficacy

In clinical trials involving 216 patients, Duragesic-25 was evaluated for its safety and efficacy in managing chronic pain. The trials highlighted the drug's effectiveness in providing around-the-clock pain relief but also underscored the risks associated with its use, such as serious or life-threatening hypoventilation, especially in non-opioid tolerant patients[4].

Pharmacokinetics

Studies have shown that serum fentanyl concentrations increase gradually after the initial application of Duragesic-25, 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 20 and 72 hours after initial application[1][3].

Special Populations

In pediatric patients, particularly those aged 1.5 to 5 years who are not opioid-tolerant, fentanyl plasma concentrations were found to be approximately twice as high as those in adult patients. This necessitates careful dosing and monitoring in pediatric populations[3].

Market Analysis

Indications and Limitations

Duragesic-25 is indicated for the management of severe chronic pain in opioid-tolerant patients where alternative treatments are inadequate. It is contraindicated in patients who are not opioid-tolerant, in the management of acute pain, post-operative pain, mild pain, and intermittent pain[1][4][5].

Market Demand

The demand for Duragesic-25 is driven by the growing need for effective chronic pain management. Chronic pain affects a significant portion of the population, and the opioid-tolerant segment requires potent and reliable analgesics. However, the market is also influenced by the opioid crisis, leading to stricter regulations and prescribing practices[4].

Competitive Landscape

The market for transdermal fentanyl patches includes both branded and generic versions. Duragesic-25, marketed by Janssen Pharmaceuticals, competes with generic versions from companies like Mylan and Apotex. The competition is intense, with generic options often being more cost-effective, which can impact the market share of the branded product[2][5].

Projections

Future Market Trends

Given the ongoing need for chronic pain management and the evolving regulatory landscape, the market for Duragesic-25 is expected to remain stable but with potential for growth in specific segments. Here are some key trends:

Increasing Focus on Safety

There will be a continued emphasis on safety measures to mitigate the risks associated with opioid use. This includes stricter prescribing guidelines, monitoring programs, and patient education initiatives[1][4].

Generic Competition

The presence of generic alternatives will continue to impact the market share of Duragesic-25. However, the brand's reputation and the loyalty of healthcare providers may help maintain its position in the market[2][5].

Regulatory Environment

Regulatory changes and guidelines will play a crucial role in shaping the market. Stricter regulations on opioid prescriptions and increased scrutiny on opioid-related deaths may influence prescribing practices and affect market dynamics[4].

Technological Advancements

Advancements in drug delivery systems and the development of new formulations could potentially disrupt the market. However, Duragesic-25's established presence and the trust it has built among healthcare providers will likely help it remain a viable option[1][3].

Key Takeaways

• Clinical Trials: Duragesic-25 has been extensively studied in opioid-tolerant patients, highlighting its efficacy and safety profile.
• Market Analysis: The drug is indicated for severe chronic pain management in opioid-tolerant patients, with a competitive market including both branded and generic options.
• Projections: The market is expected to be influenced by safety measures, generic competition, regulatory changes, and technological advancements.

FAQs

What is Duragesic-25 used for?

Duragesic-25 is used for the management of severe chronic pain in opioid-tolerant patients who require daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate[1][4][5].

Who should not use Duragesic-25?

Duragesic-25 is contraindicated in patients who are not opioid-tolerant, in the management of acute pain, post-operative pain, mild pain, and intermittent pain[1][4][5].

How does Duragesic-25 work?

Duragesic-25 is a transdermal patch that releases fentanyl at a nearly constant rate over 72 hours. The fentanyl is absorbed through the skin, creating a depot in the upper skin layers before being released into the systemic circulation[1][3].

What are the risks associated with Duragesic-25?

The primary risks include serious or life-threatening hypoventilation, especially in non-opioid tolerant patients, and the potential for overdose and death due to the potent nature of fentanyl[1][4].

Can Duragesic-25 be used in pediatric patients?

Yes, but with caution. In pediatric patients, especially those aged 1.5 to 5 years who are not opioid-tolerant, fentanyl plasma concentrations can be significantly higher than in adults, requiring careful dosing and monitoring[3].

How does the regulatory environment impact Duragesic-25?

The regulatory environment, including stricter prescribing guidelines and increased scrutiny on opioid use, can influence prescribing practices and affect market dynamics for Duragesic-25[4].

Sources

1. FDA Label: Duragesic Label Page 1 Full Prescribing Information.
2. Clinical Trials: Determination of Serum Fentanyl Levels After Using Reference (Duragesic) and Generic Fentanyl Transdermal Patches.
3. FDA NDA: Duragesic Generic Name: Fentanyl.
4. RxList: Duragesic (Fentanyl Transdermal): Side Effects, Uses.
5. Medicines.org.uk: Durogesic DTrans 25 mcg/hr Transdermal Patch.