CLINICAL TRIALS PROFILE FOR FENTORA

All Clinical Trials for Fentora

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00387010 ↗	Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain	Terminated	Cephalon	Phase 3	2006-12-01	The primary purpose of the study is to evaluate the impact of treatment with fentanyl buccal tablets on the anxiety symptoms commonly associated with chronic pain in patients with breakthrough pain (BTP). Other purposes are to assess the management of BTP, to evaluate patient functioning, and to determine any influences on the successful dose achieved.
NCT00685295 ↗	Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain	Completed	Massachusetts General Hospital	Phase 1/Phase 2	2008-08-01	Assess whether transbuccal fentanyl provides more rapid relief of orthopedic pain, than does the comparator Percocet
NCT00842829 ↗	Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients	Terminated	Cephalon	Phase 4	2009-01-01	Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. Fentanyl Buccal Tablet (FBT) is used for the treatment of BTP in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. FBT treatment should be individually titrated to an effective dose that provides adequate analgesia and minimizes undesirable effects. To reach the safest effective dose for the individual patient as soon as possible, the dose titration process is critical. The aim of this study, conducted under pragmatic conditions in a large-scale population of cancer patients is to compare the proportion of patients reaching an effective FBT dose after titration starting with either a 100 mcg dose or a 200 mcg dose.

Clinical Trial Conditions for Fentora

Condition Name

Condition Name for Fentora
Intervention	Trials
Breakthrough Pain	2
Pain	2
Wrist Injuries	1

Condition MeSH

Condition MeSH for Fentora
Intervention	Trials
Breakthrough Pain	2
Dyspnea	1
Fibrosis	1

Clinical Trial Locations for Fentora

Trials by Country

Trials by Country for Fentora
Location	Trials
United States	30
Italy	1
United Kingdom	1
Ireland	1
Spain	1

Trials by US State

Trials by US State for Fentora
Location	Trials
Pennsylvania	3
Illinois	2
Georgia	2
Florida	2
Utah	2

Clinical Trial Progress for Fentora

Clinical Trial Phase

Clinical Trial Phase for Fentora
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Fentora
Clinical Trial Phase	Trials
Recruiting	3
Completed	3
Withdrawn	3

Clinical Trial Sponsors for Fentora

Sponsor Name

Sponsor Name for Fentora
Sponsor	Trials
Hospira, Inc.	3
Hospira, now a wholly owned subsidiary of Pfizer	3
Cephalon	2

Sponsor Type

Sponsor Type for Fentora
Sponsor	Trials
Other	11
Industry	8
NIH	1

Fentanyl and Fentora: Clinical Trials, Market Analysis, and Projections

Introduction to Fentanyl and Fentora

Fentanyl, a potent synthetic opioid, is widely used for managing severe pain, particularly in cancer patients. Fentora, a brand name for fentanyl, is specifically designed for the treatment of breakthrough pain in cancer patients. Here, we will delve into the current state of clinical trials, market analysis, and future projections for fentanyl and Fentora.

Clinical Trials Update for Fentanyl Vaccine

While Fentora itself is not undergoing new clinical trials, a significant development in the fight against fentanyl overdose is the upcoming clinical trials for a fentanyl vaccine.

• University of Houston Vaccine: Researchers at the University of Houston have developed a fentanyl vaccine that is set to enter Phase I clinical trials in the second quarter of 2025. This vaccine aims to prevent fentanyl from entering the brain and causing an overdose. The vaccine has shown promise in animal studies and uses an adjuvant that has been tested in 15 human clinical trials with minimal side effects[1].

• Challenges in Recruitment: One of the major challenges in conducting these trials is recruiting participants. The FDA requires that the vaccine be tested in individuals with a history of opioid use disorder, which is a harder population to recruit due to stigma and other factors[1].

Market Analysis for Fentanyl

Current Market Size and Growth

• The global fentanyl market was valued at over USD 17.02 billion in 2024 and is projected to exceed USD 37.54 billion by 2037, growing at a CAGR of 6.4% during the forecast period from 2025 to 2037[2].

Drivers of Market Growth

• Increasing Cancer Prevalence: The rise in cancer cases globally is a significant driver. According to the World Health Organization (WHO), cancer deaths increased from 9.6 million in 2018 to over 10 million in 2020. This increase in cancer cases necessitates more fentanyl for pain management[2].

• Global Healthcare Spending: Increased healthcare spending worldwide also contributes to market growth. In 2018, global healthcare spending per capita was USD 1,111,082, up from USD 999,104 in 2015[2].

• Awareness and Therapeutic Effects: Growing awareness campaigns about the therapeutic effects of fentanyl are expected to expand the market during the forecast period[2].

Market Segmentation

• End-User Segmentation: The market is segmented into hospitals, oncology centers, surgical centers, and others. Oncology centers are expected to hold the largest market share by 2037, driven by the specific focus on cancer treatments[2].

• Regional Market: The North American region is projected to hold the largest market share by 2037, driven by a growing population, increased research activity, and comprehensive health insurance coverage for cancer diagnoses[2].

Projections for Fentanyl Market

Regional Growth

• North America: This region is expected to dominate the market due to factors such as growing population, increased research, and robust health insurance policies that cover various cancer treatments[2].

• Asia Pacific: The Asia Pacific region is projected to hold the second-largest share, driven by an aging population and government initiatives to raise awareness about cancer and its treatments[2].

Future Trends

• Increased Investment in Medical Research: Governments and private entities are investing heavily in medical research, which is expected to lead to the development of new treatments and further boost the fentanyl market[2].

• Cancer Awareness and Prevention: Global initiatives aimed at reducing cancer mortality, such as those recommended by the World Health Assembly, will continue to drive the demand for fentanyl[2].

Regulatory Environment for Fentora

FDA Oversight

• Fentora, like other extended-release and long-acting (ER/LA) opioid pain medications, is subject to strict regulatory oversight. The FDA has required a Risk Evaluation and Mitigation Strategy (REMS) program to ensure the safe use of these medications. For Fentora, the FDA has strengthened warnings and required a REMS program due to concerns about its safe use[3].

Conclusion

The fentanyl market, including products like Fentora, is poised for significant growth driven by increasing cancer prevalence, global healthcare spending, and awareness campaigns. However, the development of a fentanyl vaccine represents a new frontier in addressing the opioid crisis. As clinical trials for this vaccine progress, they may offer a groundbreaking solution to the deadly fentanyl overdose crisis.

Key Takeaways

• Clinical Trials: Phase I clinical trials for a fentanyl vaccine are set to begin in 2025, targeting individuals with opioid use disorder.
• Market Growth: The global fentanyl market is projected to grow from USD 17.02 billion in 2024 to over USD 37.54 billion by 2037.
• Regional Dominance: North America is expected to hold the largest market share, followed by the Asia Pacific region.
• Regulatory Oversight: Fentora and similar opioids are subject to strict FDA regulations, including REMS programs.

FAQs

1. What is the purpose of the fentanyl vaccine currently in development?

   • The fentanyl vaccine aims to prevent fentanyl from entering the brain and causing an overdose, potentially saving lives in the context of the opioid crisis[1].

2. When are the clinical trials for the fentanyl vaccine expected to start?

   • Phase I clinical trials for the University of Houston's fentanyl vaccine are planned to begin in the second quarter of 2025[1].

3. What are the main drivers of the fentanyl market growth?

   • The main drivers include the increasing prevalence of cancer, growing global healthcare spending, and increased awareness campaigns about the therapeutic effects of fentanyl[2].

4. Which region is expected to dominate the fentanyl market by 2037?

   • The North American region is projected to hold the largest market share by 2037[2].

5. What regulatory measures are in place for Fentora and similar opioids?

   • Fentora and other ER/LA opioids are subject to REMS programs and strengthened warnings to ensure safe use, as mandated by the FDA[3].

Sources

1. Fentanyl vaccine heads for clinical trials, with goal of saving lives. (2024, September 2). Retrieved January 2, 2025, from https://medicalxpress.com/news/2024-09-fentanyl-vaccine-clinical-trials-goal.html
2. Fentanyl Market Size | Growth Analysis 2025-2037. (2024, October 10). Research Nester. Retrieved January 2, 2025.
3. Overdose Prevention Activities Timeline - FDA. FDA. Retrieved January 2, 2025.