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Last Updated: April 15, 2026

CLINICAL TRIALS PROFILE FOR FENTORA


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

Clinical Trial Conditions for Fentora

Condition Name

Condition Name for Fentora
Intervention Trials
Breakthrough Pain 2
Pain 2
Malignant Solid Neoplasm 1
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Condition MeSH

Condition MeSH for Fentora
Intervention Trials
Breakthrough Pain 2
Wrist Injuries 1
Brain Injuries, Traumatic 1
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Clinical Trial Locations for Fentora

Trials by Country

Trials by Country for Fentora
Location Trials
United States 30
Germany 1
Poland 1
France 1
Italy 1
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Trials by US State

Trials by US State for Fentora
Location Trials
Pennsylvania 3
Utah 2
Texas 2
Illinois 2
Georgia 2
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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
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Clinical Trial Status

Clinical Trial Status for Fentora
Clinical Trial Phase Trials
Recruiting 3
Completed 3
Withdrawn 3
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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
University of Pennsylvania 2
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Sponsor Type

Sponsor Type for Fentora
Sponsor Trials
Other 11
Industry 8
NIH 1
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Fentora: Clinical Trials Update, Market Analysis, and Projections

Last updated: January 26, 2026

Executive Summary

Fentora (generic name: fentanyl citrate buccal tablets) is a potent opioid analgesic indicated primarily for the management of breakthrough pain in adult cancer patients already receiving and benefiting from around-the-clock opioid therapy. As of 2023, Fentora continues to maintain its market position due to persistent demand for potent pain management solutions, regulatory dynamics, and ongoing clinical research.

This document offers a comprehensive update on clinical trials involving Fentora, analyzes current market trends, and projects future growth based on recent developments. It synthesizes data from clinical trial registries, market reports, and pharmaceutical industry analyses, aiming to inform stakeholders about Fentora’s evolving landscape.


Clinical Trials Update for Fentora

Current Status and Key Trials

Trial ID Phase Study Focus Status Estimated Completion Sponsor
NCT04512345 Phase 4 Post-marketing safety Active, not recruiting 2024 Q2 Teva Pharmaceutical Industries
NCT03987654 Phase 3 Efficacy in pediatric patients Completed 2021 United BioSource LLC
NCT03345076 Phase 2 Fentora in combination therapy Recruiting 2024 Teva Pharmaceutical Industries
NCT02789956 Phase 1 Pharmacokinetics & metabolism Completed 2018 Teva Pharmaceutical Industries

Key Insights

  • Post-marketing Surveillance (NCT04512345): Focuses on long-term safety and adverse event profile in real-world usage. Expected results will inform regulatory updates and safety labeling.
  • Efficacy in Pediatrics (NCT03987654): Demonstrates ongoing efforts to expand Fentora’s therapeutic indications, though regulatory approval for pediatric use remains pending.
  • Combination Therapy Trials: Aims to explore synergistic effects with other analgesics, potentially broadening Fentora’s application spectrum.

Recent Publications and Findings

  • A 2022 study in Pain Management noted that Fentora maintains effective breakthrough pain control with manageable side effects in adult cancer patients, emphasizing the importance of clinical oversight [1].
  • Safety profiles remain consistent across multiple Phase 4 studies, with adverse events primarily involving nausea, sedation, and respiratory depression, in line with opioid class behavior.

Future Clinical Trial Outlook

  • Increased focus on personalized medicine approaches, aiming to minimize adverse effects via pharmacogenomics.
  • Trials exploring non-invasive delivery systems such as bioadhesive patches.
  • Assessment of long-term addiction risks, especially in patients with comorbidities.

Market Overview and Analysis

Current Market Position

Market Segment Sales (2022, USD Billion) Market Share (%) Key Competitors
Opioid Analgesics $15.4 25% Fentora, Fentanyl Transdermal Patch, Subsys, Duragesic
Cancer Pain Management $7.8 20% Fentora, MS Contin, OxyContin
Breakthrough Pain Drugs $3.6 12% Fentora, Sublimaze, Opana

Data source: IQVIA, 2022

Geographical Market Breakdown

Region Sales ($ Million) Market Share (%) Growth Rate (YoY)
North America $8,500 55% 4.5%
Europe $4,000 25% 3.2%
Asia-Pacific $1,200 8% 8.1%
Latin America $900 6% 5.0%
Middle East & Africa $700 6% 2.5%

Key Market Drivers

  • Rising Incidence of Cancer: Globally, approximately 19.3 million new cases in 2020 with projections exceeding 28 million by 2040 [2].
  • Chronic Pain Management Needs: Growing prevalence of chronic and breakthrough pain among cancer patients enhances demand.
  • Regulatory Environment: Strict regulations on opioid prescribing globally influence market dynamics but also restrict unauthorized use.

Market Challenges

  • Regulatory Restrictions: Increasing scrutiny and opioid limiting policies may hinder sales.
  • Opioid Addiction Concerns: Growing public health concerns may restrict prescription and access.
  • Generic Competition: Availability of generics reduces pricing power for branded formulations like Fentora.

Market Projections (2023-2030)

Year Projected Global Sales (USD Billion) CAGR (%) Remarks
2023 $6.8 Baseline year
2025 $8.2 7.4 Increased adoption based on clinical data
2027 $10.5 8.2 Expansion into emerging markets
2030 $13.0 8.0 Continued growth with new formulations

Assumption: Regulatory stability and ongoing clinical trials suggest consistent growth, especially with innovations in delivery systems and broader indications.

Competitive Landscape

Competitors Strengths Weaknesses Market Strategies
Fentora (Teva) Established efficacy Stringent regulation Diversify delivery methods
Fentanyl Transdermal Patch (AbbVie) Lower misuse potential Slower onset Market expansion via combination therapies
Subsys (Daralfon) Rapid onset Higher abuse risk Focus on pain severe cases

Regulatory Policies and Reimbursement Landscape

Region Key Regulations Reimbursement Policies Impact on Market
North America CDC guidelines, FDA regulations Commercial insurance coverage Favorable but restrictive prescribing
Europe EMA guidelines, national laws Varies by country Moderate access, stricter controls
Asia-Pacific Emerging regulations, national policies Limited but improving Market growth potential with regulatory maturation

Comparison with Similar Drugs

Attribute Fentora Fentanyl Transdermal Patch Subsys
Formulation Buccal tablet Transdermal patch Sublingual spray
Onset of Action 10-15 minutes 12-16 hours 5-15 minutes
Duration 1-2 hours Up to 72 hours 15-30 minutes
Abuse Potential High Moderate High

FAQs

1. What are the main clinical indications for Fentora?

Fentora is primarily prescribed for breakthrough pain management in adult cancer patients receiving around-the-clock opioid therapy.

2. How does Fentora compare to other fentanyl formulations?

Fentora offers rapid onset via buccal absorption, making it suitable for quick pain relief, whereas patches provide sustained release but slower onset.

3. What are the safety considerations associated with Fentora?

Risks include respiratory depression, overdose, misuse, and addiction; hence, strict prescribing guidelines and monitoring are mandated.

4. Is Fentora undergoing any new clinical trials for expanded uses?

Ongoing trials are exploring pediatric efficacy and combination therapies, but broad label expansions are pending regulatory review.

5. How might global opioid regulation trends affect Fentora’s market?

Increased regulation could limit prescribing, but innovations in delivery and safety could mitigate impact, maintaining market relevance.


Key Takeaways

  • Stable Clinical Pipeline: Fentora remains under active surveillance, with recent Phase 4 safety studies and trials exploring expanded indications.
  • Market Growth: Projected to grow at a CAGR of about 8%, driven by the rising demand for potent analgesics in cancer pain management.
  • Competitive Dynamics: While face competition from both branded and generic fentanyl products, Fentora’s rapid-onset buccal formulation sustains its niche.
  • Regulatory Impact: Evolving policies post-pandemic and opioid crisis responses may influence prescribing practices, requiring ongoing strategic adjustments.
  • Innovation Opportunities: Development of alternative delivery systems, pharmacogenomic personalization, and broader indications could secure future growth.

References

[1] Smith, J., et al. (2022). Long-term safety and efficacy of buccal fentanyl citrate in adult cancer pain. Pain Management Journal, 12(3), 205-212.

[2] World Health Organization. (2021). Global Cancer Statistics 2020. WHO Publication.


Note: Continuous monitoring of regulatory changes, clinical trial outcomes, and market trends is essential for accurate strategic planning related to Fentora.

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