CLINICAL TRIALS PROFILE FOR DURAGESIC-50

505(b)(2) Clinical Trials for Duragesic-50

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-50

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-50

Condition Name

Condition Name for Duragesic-50
Intervention	Trials
Pain	5
Healthy	5
Chronic Pain	3
Peer Review, Research	2

Condition MeSH

Condition MeSH for Duragesic-50
Intervention	Trials
Chronic Pain	3
Pain, Postoperative	3
Mucositis	2
Tachycardia	1

Clinical Trial Locations for Duragesic-50

Trials by Country

Trials by Country for Duragesic-50
Location	Trials
United States	29
Thailand	2
Canada	1

Trials by US State

Trials by US State for Duragesic-50
Location	Trials
California	3
Utah	2
Massachusetts	2
Illinois	2
Georgia	2

Clinical Trial Progress for Duragesic-50

Clinical Trial Phase

Clinical Trial Phase for Duragesic-50
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Duragesic-50
Clinical Trial Phase	Trials
Completed	18
Recruiting	2
Terminated	2

Clinical Trial Sponsors for Duragesic-50

Sponsor Name

Sponsor Name for Duragesic-50
Sponsor	Trials
University of Maryland, Baltimore	2
Janssen Research & Development, LLC	2
Khon Kaen University	2

Sponsor Type

Sponsor Type for Duragesic-50
Sponsor	Trials
Other	17
Industry	12
U.S. Fed	2

DURAGESIC-50: Clinical Trials, Market Analysis, and Projections

Introduction

DURAGESIC-50, a transdermal fentanyl system, 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 projections for this drug.

Clinical Trials Overview

Patient Eligibility and Indications

DURAGESIC-50 is indicated for opioid-tolerant patients who require daily, around-the-clock, long-term opioid treatment for severe pain that is not manageable with other treatment options. Patients are considered opioid-tolerant if they have been taking at least 60 mg of oral morphine, 30 mg of oral oxycodone, or 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid, for one week or longer[1][3][4].

Safety and Efficacy

Clinical trials have highlighted the efficacy of DURAGESIC-50 in managing chronic pain, but they also underscore the significant risks associated with its use. In trials involving 357 non-opioid tolerant subjects, 13 subjects experienced hypoventilation, a serious and potentially life-threatening side effect[1][3][4].

Pharmacokinetics

The pharmacokinetic profile of DURAGESIC-50 shows that serum fentanyl concentrations increase gradually after application, 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][3][4].

Contraindications

DURAGESIC-50 is contraindicated in patients who are not opioid-tolerant, for the management of acute pain, post-operative pain, mild pain, and intermittent pain. It is also contraindicated in patients with significant respiratory depression or other conditions that could exacerbate respiratory risks[1][3][4].

Market Analysis

Market Demand

The demand for DURAGESIC-50 and other fentanyl products is driven by the need for effective pain management in chronic pain patients. The opioid market, while fraught with risks of addiction and abuse, continues to see demand due to the severe pain conditions that these drugs address.

Competition

The market for transdermal fentanyl systems includes both branded and generic versions. Mylan, for example, markets a generic fentanyl transdermal system that is bioequivalent to DURAGESIC-50[5]. This competition can impact pricing and market share.

Regulatory Environment

The FDA has implemented a Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics, including DURAGESIC-50, to mitigate the risks of addiction, abuse, and misuse. This regulatory oversight affects how the drug is prescribed, monitored, and marketed[4].

Market Projections

Growth Potential

Despite the challenges and risks associated with opioid use, the chronic pain management market is expected to grow. The increasing prevalence of chronic pain conditions and the need for effective treatment options will continue to drive demand for DURAGESIC-50 and similar products.

Challenges and Opportunities

The opioid crisis and associated regulatory scrutiny pose significant challenges to the market growth of DURAGESIC-50. However, opportunities exist in improving patient safety through better prescribing practices, monitoring, and education. Innovations in delivery systems and formulations that reduce the risk of abuse and overdose could also enhance market prospects.

Global Market

The global market for transdermal fentanyl systems is expected to expand, driven by increasing healthcare spending and the growing need for pain management solutions. However, regional variations in regulatory environments and healthcare systems will influence market dynamics.

Key Safety Considerations

Respiratory Depression

One of the most critical safety concerns with DURAGESIC-50 is the risk of serious or life-threatening respiratory depression, especially during the initial application period and in patients who are not opioid-tolerant[1][3][4].

Accidental Exposure

Accidental exposure, particularly in children, can lead to fatal overdose. Therefore, strict handling and disposal guidelines are essential[4].

Concomitant Use with Other Medications

The use of DURAGESIC-50 with potent cytochrome P450 3A4 inhibitors can significantly increase fentanyl levels, leading to increased risks of adverse effects[1][3][4].

Special Populations

Elderly Patients

Elderly patients may be more susceptible to the adverse effects of DURAGESIC-50, including respiratory depression and hypotension. Close monitoring is recommended[4].

Pediatric Patients

In pediatric patients, especially those who are non-opioid tolerant, fentanyl plasma concentrations can be significantly higher than in adults. This necessitates careful dosing and monitoring[3].

Conclusion

DURAGESIC-50 is a potent opioid analgesic with a well-established role in the management of severe, chronic pain in opioid-tolerant patients. While it offers effective pain relief, it is associated with significant risks that must be carefully managed. The market for this drug is influenced by regulatory environments, competition from generics, and the ongoing opioid crisis.

Key Takeaways

• Indications: DURAGESIC-50 is indicated for opioid-tolerant patients with severe, chronic pain.
• Safety Risks: Serious risks include respiratory depression, accidental exposure, and interactions with other medications.
• Market Dynamics: The market is influenced by regulatory oversight, competition, and the need for effective pain management solutions.
• Growth Potential: Despite challenges, the market for chronic pain management is expected to grow.
• Special Populations: Elderly and pediatric patients require careful monitoring and dosing adjustments.

FAQs

Q: Who is eligible for DURAGESIC-50?

A: Patients who are opioid-tolerant and require daily, around-the-clock, long-term opioid treatment for severe pain.

Q: What are the primary risks associated with DURAGESIC-50?

A: Serious or life-threatening respiratory depression, accidental exposure, and interactions with other medications.

Q: How is DURAGESIC-50 administered?

A: It is administered via a transdermal patch that is worn continuously for up to 72 hours.

Q: Can DURAGESIC-50 be used in non-opioid tolerant patients?

A: No, it is contraindicated in patients who are not opioid-tolerant due to the risk of fatal respiratory depression.

Q: What regulatory measures are in place for DURAGESIC-50?

A: The FDA has implemented a Risk Evaluation and Mitigation Strategy (REMS) to mitigate the risks of addiction, abuse, and misuse.

Sources

1. Duragesic Label Page 1 Full Prescribing Information - FDA.
2. Fentanyl availability on darknet markets - Australian Institute of Criminology.
3. Duragesic Generic Name: Fentanyl - FDA.
4. Duragesic - FDA.
5. Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour, and 100 mcg/hour - FDA.