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

Condition MeSH

Condition MeSH for Duragesic-12
Intervention	Trials
Chronic Pain	3
Pain, Postoperative	3
Mucositis	2
Psychomotor Agitation	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
Massachusetts	2
Illinois	2
Georgia	2
Florida	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
Recruiting	2
Terminated	2

Clinical Trial Sponsors for Duragesic-12

Sponsor Name

Sponsor Name for Duragesic-12
Sponsor	Trials
Janssen Research & Development, LLC	2
Khon Kaen University	2
National Cancer Institute (NCI)	2

Sponsor Type

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

Duragesic-12: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Duragesic-12, a transdermal fentanyl patch, is a potent opioid analgesic used for the management of chronic pain in opioid-tolerant patients. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Approval History

Duragesic was originally approved by the FDA in 1990 for the management of chronic pain in patients requiring opioid analgesia, based on clinical trials evaluating patients with chronic pain due to malignancy[3].

• Initial Approval: The initial approval was for the management of chronic pain in patients who were opioid-tolerant. Over the years, the FDA has narrowed the approved use and expanded the warnings due to the risks associated with long-acting opioids[3].
• Clinical Pharmacology: Studies have shown that the application of heat over the Duragesic system can increase fentanyl exposure, leading to potential adverse effects such as respiratory depression and sedation[4].
• Pharmacokinetics: Clinical trials indicate that serum fentanyl concentrations increase gradually following the initial application of the patch, leveling off between 12 and 24 hours and remaining relatively constant for the remainder of the 72-hour application period[1][5].

Indications and Usage

Duragesic-12 is specifically indicated for the management of pain in opioid-tolerant patients who require daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate.

• Patient Eligibility: Patients are considered opioid-tolerant if they have been taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, or an equianalgesic dose of another opioid for one week or longer[4].
• Contraindications: The use of Duragesic is contraindicated in the treatment of post-operative and acute pain and in patients who are not opioid-tolerant due to the risk of serious or life-threatening hypoventilation[1][3].

Market Analysis

Market Presence

Duragesic has been a significant player in the opioid analgesic market, particularly for chronic pain management.

• Competitive Landscape: The market for transdermal fentanyl patches is competitive, with several brands available. However, Duragesic remains one of the most recognized and prescribed options due to its long history and established efficacy[3].
• Prescription Trends: The prescription trends for Duragesic have been influenced by the broader opioid crisis and regulatory changes. There has been a shift towards more cautious prescribing practices, especially for opioid-naïve patients[3].

Darknet Markets and Illicit Use

While Duragesic is a prescription medication, there is also a concern about its availability on darknet markets.

• Illicit Availability: Studies have shown that fentanyl, including prescription products like Duragesic, is available on darknet markets. This poses significant risks due to the potential for misuse and overdose[2].

Projections and Future Outlook

Regulatory Environment

The regulatory environment continues to evolve, impacting the use and prescription of opioids like Duragesic.

• FDA Warnings and Guidelines: The FDA has issued several updates to the Duragesic label, including black box warnings and limitations on its use. These changes reflect the ongoing efforts to mitigate the risks associated with opioid use[3][4].
• Prescribing Practices: Future prescribing practices are likely to be even more stringent, with a focus on opioid stewardship and reducing the risk of addiction and overdose.

Market Growth

Despite the challenges, the demand for effective chronic pain management solutions is expected to continue.

• Chronic Pain Prevalence: The prevalence of chronic pain is high, and there is an ongoing need for effective treatment options. Duragesic, with its established efficacy, is likely to remain a viable option for opioid-tolerant patients[3].
• Innovation and Alternatives: The market is also seeing the development of alternative pain management therapies, including non-opioid analgesics and innovative delivery systems. However, Duragesic's position as a well-established treatment is expected to endure[4].

Risks and Safety Considerations

Respiratory Depression

One of the most significant risks associated with Duragesic is respiratory depression.

• Clinical Evidence: Clinical trials and post-marketing surveillance have highlighted the risk of serious or life-threatening hypoventilation, particularly during the initial application period and in patients who are not opioid-tolerant[1][3].
• Monitoring and Management: Patients must be closely monitored, especially during initiation and titration, to manage this risk effectively[4].

Interactions and Concomitant Use

The concomitant use of Duragesic with other medications can also pose risks.

• Cytochrome P450 3A4 Inhibitors: The use of potent cytochrome P450 3A4 inhibitors can significantly increase fentanyl levels, leading to increased risks of adverse effects[1].
• Serotonergic Drugs: Concomitant use with serotonergic drugs can result in serotonin syndrome, a potentially life-threatening condition[4].

Key Takeaways

• Clinical Trials: Duragesic has a robust clinical trial history supporting its efficacy in chronic pain management.
• Market Presence: It remains a significant player in the opioid analgesic market despite regulatory challenges.
• Regulatory Environment: Ongoing regulatory updates aim to mitigate the risks associated with opioid use.
• Safety Considerations: Close monitoring is essential to manage risks such as respiratory depression and drug interactions.
• Future Outlook: The demand for chronic pain management solutions will continue, with Duragesic likely to remain a viable option for opioid-tolerant patients.

FAQs

Q: What is Duragesic-12 used for?

A: Duragesic-12 is used for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients who require continuous, around-the-clock opioid administration[3].

Q: What are the risks associated with Duragesic?

A: The primary risks include serious or life-threatening hypoventilation, especially in non-opioid tolerant patients, and interactions with other medications such as cytochrome P450 3A4 inhibitors and serotonergic drugs[1][4].

Q: How is Duragesic administered?

A: Duragesic is administered via a transdermal patch that delivers fentanyl through the skin over a 72-hour period[1].

Q: Can Duragesic be used for acute pain?

A: No, Duragesic is contraindicated for the treatment of post-operative and acute pain due to the risk of respiratory depression[1][3].

Q: How does the regulatory environment impact Duragesic prescriptions?

A: The regulatory environment has led to more stringent prescribing practices, with a focus on opioid stewardship and reducing the risk of addiction and overdose. The FDA has issued several updates to the Duragesic label to reflect these changes[3][4].

Sources

1. Duragesic Label Page 1 Full Prescribing Information - FDA
2. Fentanyl availability on darknet markets - Australian Institute of Criminology
3. Duragesic's FDA-Approved Label - Texas Attorney General
4. Duragesic - accessdata.fda.gov - FDA
5. Fentanyl Transdermal System (TDS) Informational Summary - VA.gov