CLINICAL TRIALS PROFILE FOR DURAGESIC-75

505(b)(2) Clinical Trials for Duragesic-75

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-75

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.

Clinical Trial Conditions for Duragesic-75

Condition Name

Condition Name for Duragesic-75
Intervention	Trials
Pain	5
Healthy	5
Chronic Pain	3
Peer Review, Research	2

Condition MeSH

Condition MeSH for Duragesic-75
Intervention	Trials
Pain, Postoperative	3
Chronic Pain	3
Mucositis	2
Head and Neck Neoplasms	1

Clinical Trial Locations for Duragesic-75

Trials by Country

Trials by Country for Duragesic-75
Location	Trials
United States	29
Thailand	2
Canada	1

Trials by US State

Trials by US State for Duragesic-75
Location	Trials
California	3
Maryland	2
West Virginia	2
Utah	2
Massachusetts	2

Clinical Trial Progress for Duragesic-75

Clinical Trial Phase

Clinical Trial Phase for Duragesic-75
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Duragesic-75
Clinical Trial Phase	Trials
Completed	18
Terminated	2
Recruiting	2

Clinical Trial Sponsors for Duragesic-75

Sponsor Name

Sponsor Name for Duragesic-75
Sponsor	Trials
Mylan Pharmaceuticals	2
Food and Drug Administration (FDA)	2
Alza Corporation, DE, USA	2

Sponsor Type

Sponsor Type for Duragesic-75
Sponsor	Trials
Other	17
Industry	12
NIH	2

DURAGESIC-75: Clinical Trials, Market Analysis, and Projections

Introduction

DURAGESIC-75, a transdermal fentanyl system, is a potent opioid analgesic used for the management of moderate to 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

Efficacy and Safety

Clinical trials have shown that DURAGESIC-75 is effective in reducing pain in opioid-tolerant patients. A double-blind, placebo-controlled trial indicated that patients using DURAGESIC-75 had significantly lower visual analog scale pain scores and required less supplemental morphine compared to the placebo group[1].

However, these trials also highlighted significant safety concerns. Patients using DURAGESIC-75 experienced increased abnormal respiratory patterns, including apneic episodes and slow respiratory rates, leading to a higher requirement for oxygen supplementation. Nine patients in the DURAGESIC groups were withdrawn due to severe respiratory depression, a critical side effect that underscores the need for careful patient monitoring[1].

Comparative Studies

A feasibility study comparing transdermal fentanyl (TDF) with transdermal buprenorphine (TDB) showed that both medications were equally efficacious in managing persistent pain. However, the TDF group required higher equipotent doses for comparable pain relief. The study also noted that while the TDB group initially experienced fewer side effects, more buprenorphine users suffered from local skin reactions[4].

Pharmacokinetics and Pharmacodynamics

Drug Delivery Mechanism

DURAGESIC-75 is a drug-in-adhesive matrix formulation that releases fentanyl at a nearly constant rate. The concentration gradient between the matrix and the skin drives the drug release, with the fentanyl moving through the skin layers to the systemic circulation. Peak serum concentrations of fentanyl generally occur between 20 and 72 hours after initial application, and a steady-state serum concentration is reached by the end of the second 72-hour application period[3].

Metabolism and Elimination

Fentanyl is metabolized primarily via the cytochrome P450 3A4 isoenzyme system and is mostly eliminated in urine. Patients with impaired renal or hepatic function should use DURAGESIC-75 with caution due to the potential for altered metabolism and excretion[3].

Market Analysis

Illicit Market Impact

The illicit market for fentanyl, including products like those labelled as 'China White' (heroin laced with fentanyl), has significantly impacted the opioid landscape. Fentanyl's presence in the illicit drug market has increased the risk of overdose deaths and reduced the value of opium production in regions like Mexico. Darknet markets play a crucial role in the distribution of illicit fentanyl, with vendors often selling fentanyl under various names and forms[2].

Prescription Market

In the prescription market, DURAGESIC-75 competes with other opioid analgesics, including transdermal buprenorphine. The demand for these medications is driven by the need for effective chronic pain management. However, the strict regulations and safety concerns surrounding opioids, particularly fentanyl, can affect market dynamics and patient access[4].

Projections and Future Outlook

Regulatory Environment

Given the high potential for abuse and overdose, regulatory bodies are likely to maintain stringent controls over the prescription and distribution of DURAGESIC-75. This could impact market growth but is crucial for public health safety.

Market Growth

Despite the challenges, the market for opioid analgesics, including DURAGESIC-75, is expected to grow due to the increasing prevalence of chronic pain conditions. However, this growth will be tempered by the need for safer alternatives and stricter prescribing practices.

Innovations and Alternatives

Future developments may include safer formulations of fentanyl or alternative opioids with lower abuse potential. For instance, the use of naloxone, an opioid antagonist, in combination with opioids like fentanyl could mitigate the risk of overdose[2].

Side Effects and Safety Considerations

Respiratory Depression

One of the most critical side effects of DURAGESIC-75 is respiratory depression, which can be life-threatening. Patients must be closely monitored, especially during the initial application period[1][3].

Local Skin Reactions

Local skin reactions are another common side effect, although less severe than respiratory depression. These reactions can be managed through proper application techniques and switching between different patch types[4].

Patient Selection and Monitoring

Opioid Tolerance

DURAGESIC-75 is contraindicated in patients who are not opioid-tolerant. Prescribers must ensure that patients have a history of opioid use to minimize the risk of adverse effects[3].

Continuous Monitoring

Patients using DURAGESIC-75 should be monitored regularly for signs of respiratory depression, other adverse effects, and the need for dose adjustments. This includes monitoring serum fentanyl concentrations and adjusting the dose based on individual patient responses[3].

Key Takeaways

• Efficacy: DURAGESIC-75 is effective in reducing chronic pain in opioid-tolerant patients.
• Safety Concerns: Significant risks include respiratory depression and other adverse effects, necessitating close patient monitoring.
• Market Dynamics: The market is influenced by both legitimate medical needs and illicit distribution, with regulatory scrutiny likely to continue.
• Future Outlook: Growth is expected but will be balanced by the need for safer alternatives and stricter prescribing practices.

FAQs

Q: What is the primary use of DURAGESIC-75?

A: DURAGESIC-75 is used for the management of moderate to severe chronic pain in opioid-tolerant patients.

Q: What are the significant side effects of DURAGESIC-75?

A: The most critical side effect is respiratory depression, which can be life-threatening. Other side effects include local skin reactions and the potential for increased abnormal respiratory patterns.

Q: How does DURAGESIC-75 deliver fentanyl?

A: DURAGESIC-75 is a drug-in-adhesive matrix formulation that releases fentanyl at a nearly constant rate through the skin layers to the systemic circulation.

Q: Why is patient monitoring crucial for DURAGESIC-75?

A: Patient monitoring is essential to manage the risk of respiratory depression and other adverse effects, and to adjust the dose based on individual patient responses.

Q: What are the regulatory challenges facing DURAGESIC-75?

A: The high potential for abuse and overdose means that regulatory bodies will maintain stringent controls over the prescription and distribution of DURAGESIC-75.

Sources

1. PubMed: A double-blind, placebo-controlled trial of transdermal fentanyl after abdominal surgery.
2. Australian Institute of Criminology: Fentanyl availability on darknet markets.
3. FDA: Duragesic Generic Name: Fentanyl.
4. Pain Medicine: Feasibility Study of Transdermal Buprenorphine Versus Transdermal Fentanyl for Chronic Pain Management.