CLINICAL TRIALS PROFILE FOR BUTRANS

All Clinical Trials for BUTRANS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00312572 ↗	Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain	Completed	Purdue Pharma LP	Phase 3	2003-06-01	The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.
NCT00403234 ↗	Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement	Terminated	Purdue Pharma LP	Phase 2	2006-11-01	The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug. Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations.
NCT01324570 ↗	Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children	Completed	Purdue Pharma LP	Phase 3	2011-07-01	The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.
NCT01999114 ↗	The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers	Completed	Purdue Pharma LP	Phase 1	2012-03-01	The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.
NCT02138357 ↗	Butrans for Treatment of Restless Legs Syndrome	Withdrawn	Massachusetts General Hospital	Phase 4	2014-12-01	The primary objective of the study is to determine whether Butrans Transdermal System (BTDS) reduces RLS symptom severity in patients with moderate to severe idiopathic RLS who are naïve to opiate treatment. The secondary objective of the study is to investigate the effects of BTDS on mood, sleep, and quality of life. The study will consist of nine visits. Depending on the need for medication titration, there may also be two scheduled telephone contacts. Visit 1: This is a screening visit to determine study eligibility. Eligible subjects who choose to participate must undergo medication washout as described in the detailed protocol between visits 1 and 2. Treatment period #1 (Visits 2 - 5; day 0 - 28): Baseline measures will be recorded and subjects randomized to treatment order at visit 2 (day 0). Study medication as well as rescue medication (l-dopa, a non-blinded active treatment to be used within a limited dose range as described in the detailed protocol) will be dispensed. Subjects will begin treatment period #1 immediately after this. The study medication will be titrated within the allowed range according to subject's reported symptoms during visit 3 (day 7), visit 4 (day 14), telephone contact (day 21). Visit 5 will occur on day 28 and will include assessment of outcome measures for the first treatment period. Visit 5 will also mark the beginning of the second treatment period. Treatment period #2 (Visits 6 - 8; day 28 - 56): Procedures will be similar to those described above during treatment period #1. Visit 8 will mark the end of the second treatment period during which outcome measures will be ascertained. Follow up visit (Visit 9; day 70): This will be a safety follow-up visit approximately two weeks after visit 8 for review of adverse events.

Clinical Trial Conditions for BUTRANS

Condition Name

Condition Name for BUTRANS
Intervention	Trials
ECG Effects	1
Osteoarthritis	1
Pain	1
Postoperative Pain	1

Condition MeSH

Condition MeSH for BUTRANS
Intervention	Trials
Syndrome	1
Restless Legs Syndrome	1
Psychomotor Agitation	1
Pain, Postoperative	1

Clinical Trial Locations for BUTRANS

Trials by Country

Trials by Country for BUTRANS
Location	Trials
United States	43

Trials by US State

Trials by US State for BUTRANS
Location	Trials
Texas	3
Florida	3
California	3
Pennsylvania	2
South Carolina	2

Clinical Trial Progress for BUTRANS

Clinical Trial Phase

Clinical Trial Phase for BUTRANS
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for BUTRANS
Clinical Trial Phase	Trials
Completed	3
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for BUTRANS

Sponsor Name

Sponsor Name for BUTRANS
Sponsor	Trials
Purdue Pharma LP	4
Massachusetts General Hospital	1

Sponsor Type

Sponsor Type for BUTRANS
Sponsor	Trials
Industry	4
Other	1

Clinical Trials Update, Market Analysis, and Projection for BUTRANS

Last updated: November 2, 2025

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Introduction

BUTRANS, a transdermal buprenorphine patch, has become a notable opioid analgesic in managing chronic pain. Approved by the U.S. Food and Drug Administration (FDA) in 2001, it combines the sustained-release benefits of transdermal delivery with the potent analgesic effect of buprenorphine, a partial μ-opioid receptor agonist. As the opioid market evolves amid regulatory scrutiny and the ongoing opioid crisis, understanding the latest clinical trial developments, market dynamics, and future prospects for BUTRANS is essential for stakeholders involved in healthcare, pharmaceutical investment, and policy formulation.

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Clinical Trials Update

Current Clinical Developments

While extensive clinical testing for BUTRANS occurred prior to its initial approval, ongoing and recent clinical trials focus primarily on its safety profile, comparative efficacy, and new formulation developments to optimize pain management.

Safety and Efficacy Studies

Recent post-market surveillance studies underscore the safety profile of BUTRANS, emphasizing its low incidence of respiratory depression when used per guidelines. However, concerns around addiction potential persist, prompting further investigations into its misuse and diversion risks. Studies such as the "Safety, Tolerability, and Efficacy of Transdermal Buprenorphine in Chronic Non-Cancer Pain" (NCT04567489) continue to evaluate long-term safety in diverse patient populations, including elderly and those with comorbidities.

Formulation and Dosing Optimization Trials

Research exploring alternative dosing regimens aims to refine individualized therapy. Notably, a phase IV trial (NCT03836084) underway examines the efficacy of reduced-dose patches in elderly patients to enhance tolerability while maintaining analgesic benefits.

Novel Delivery Systems

Innovations are also underway regarding delivery mechanisms. A recent phase II study (NCT04797315) assesses a biodegradable buprenorphine patch designed for faster drug release and minimized skin irritation, potentially broadening applicability. These developments respond to clinician demands for more flexible, patient-centric options.

Regulatory and Labeling Updates

The FDA has issued warnings emphasizing the importance of adherence to prescribing guidelines due to the inherent risks of misuse. Recent updates to the drug monograph underscore contraindications in patients with severe respiratory conditions and in cases of acute pain where immediate opioid management is necessary. These regulatory updates influence ongoing clinical trial designs and patient selection criteria.

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Market Analysis

Current Market Landscape

Market Size and Segments

The global transdermal opioid patch market was valued at approximately USD 1.1 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of roughly 4% through 2030 [1]. BUTRANS dominates a segment of this market, primarily in North America and Europe, driven by its established efficacy profile and physician familiarity.

Competitor Overview

Key competitors include Butrans (Mylan), BuTrans (Lupin), and Fentanyl patches like Duragesic. However, buprenorphine's partial agonist profile positions it as a potentially safer alternative amid rising regulation and overdose concerns linked to full opioid agonists like fentanyl. New entrants, such as BEMA's BEMA Buprenorphine, are challenging incumbents with innovative delivery mechanisms.

Market Drivers

• Chronic Pain Prevalence: The rising prevalence of chronic non-cancer pain globally fuels demand.
• Shift Toward Non-Opioid and Safer Opioid Options: Clinical emphasis on minimizing misuse propels adoption of partial agonists like buprenorphine.
• Regulatory and Reimbursement Trends: Favorable coverage policies and updated guidelines promote transdermal formulations, especially in the wake of opioid epidemic mitigation strategies.

Market Challenges

• Regulatory Stringency: Increased oversight hampers rapid product expansion.
• Misuse and Diversion Risks: Public health initiatives focusing on opioid misuse restrict prescribing practices.
• Pricing and Reimbursement Pressures: Cost considerations influence physician prescribing patterns, especially in value-based care regimes.

Future Market Outlook

Growth Projections

By 2030, the transdermal buprenorphine market, including BUTRANS, is forecast to reach USD 1.7 billion, bolstered by emerging markets and expanding indications for chronic pain management [1]. Adoption in pain clinics and primary care settings is expected to increase, driven by increased awareness of the safety profile relative to full agonist opioids.

Emerging Trends

• Personalized Pain Management: Integration with digital health tools for dose titration.
• Expanded Indications: Trials evaluating efficacy in opioid dependence management could open new market sectors.
• Innovation in Delivery Platforms: Development of multi-layer patches that enable dual-drug delivery may diversify applications.

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Strategic Implications and Projections

Given the landscape, stakeholders should consider the following:

• Clinical trial investments emphasizing safety, misuse mitigation, and alternative formulations can bolster market positioning.
• Collaborations with healthcare systems for educational initiatives regarding appropriate use and safety protocols.
• Regulatory engagement to ensure timely approval of novel formulations and indications that align with evolving pain management standards.
• Market penetration strategies focusing on underpenetrated regions, especially in Asia-Pacific, where pain management markets are expanding.

The convergence of ongoing clinical validation, regulatory support for safer opioid utilization, and technological advancements indicates a positive trajectory for BUTRANS and similar buprenorphine patches.

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Key Takeaways

• Clinical trial activities for BUTRANS focus on safety, optimized dosing, and innovative delivery systems, positioning it for future expansion.
• Market dynamics favor transdermal buprenorphine due to its safer profile versus full agonist opioids; however, regulatory and misuse concerns challenge adoption.
• The global market is projected to grow steadily, with increasing acceptance driven by chronic pain prevalence and evolving treatment guidelines.
• Emerging formulations and indications, including opioid dependence treatment, could diversify revenue streams.
• Stakeholders should prioritize R&D, strategic collaborations, and regulatory engagement to capitalize on market opportunities and enhance patient safety.

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FAQs

1. How does BUTRANS compare to other opioid therapies in terms of safety and efficacy?
BUTRANS offers a targeted delivery with a lower risk of respiratory depression and misuse compared to full opioid agonists like fentanyl. Its efficacy in managing moderate to severe chronic pain is well-documented, with a favorable side effect profile when used appropriately.

2. What recent regulatory updates could impact the future use of BUTRANS?
The FDA's heightened emphasis on misuse prevention and detailed contraindications influence prescribing practices. Updated labeling underscores the necessity for careful patient selection and monitoring, potentially affecting market growth.

3. Are there ongoing clinical trials assessing new indications for BUTRANS?
Yes, trials are exploring its utility in opioid addiction management and in multimodal pain strategies, which could open new therapeutic avenues.

4. What are the main competitive advantages of BUTRANS in the current market?
Its transdermal delivery provides consistent pain control, improved compliance, and a lower incidence of gastrointestinal side effects, setting it apart from oral opioids.

5. How might technological innovations influence the future of buprenorphine patches?
Advancements such as biodegradable patches, multi-layer drug delivery systems, and digital monitoring integration could enhance safety, efficacy, and patient engagement, expanding market potential.

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References

[1] MarketWatch, "Global Transdermal Opioid Patch Market Size, Industry Report 2022–2030," 2022.