CLINICAL TRIALS PROFILE FOR BUTRANS

All Clinical Trials for BUTRANS

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

Clinical Trial Conditions for BUTRANS

Condition Name

Condition Name for BUTRANS
Intervention	Trials
Osteoarthritis	1
Pain	1
Postoperative Pain	1
Restless Legs Syndrome	1

Condition MeSH

Condition MeSH for BUTRANS
Intervention	Trials
Restless Legs Syndrome	1
Psychomotor Agitation	1
Pain, Postoperative	1
Osteoarthritis	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
Florida	3
California	3
Texas	3
Louisiana	2
Kentucky	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

Buprenorphine Transdermal Patches: Clinical Trials, Market Analysis, and Projections for Butrans

Introduction to Butrans

Butrans, a brand name for the buprenorphine transdermal patch, is a medication used for the management of moderate to severe chronic pain in patients who require around-the-clock opioid analgesia. Here, we will delve into recent clinical trials, market analysis, and future projections for Butrans.

Clinical Trials and Efficacy

Managing Opioid Dependence in Cancer Survivors

A recent clinical trial in Korea evaluated the efficacy and safety of a transdermal buprenorphine patch (TBP) in managing physical dependence on prescription opioids in cancer survivors. The study involved a 4-phase treatment protocol and reported a success rate of 61% in opioid discontinuation at 8 weeks. This indicates that buprenorphine patches can be an effective treatment option for opioid dependence in this population[1].

Pediatric Safety and Utilization

The FDA has reviewed the safety and pharmacokinetics of Butrans in pediatric patients aged 7 through 16 years in an open-label, multicenter study. Although the study did not establish definitive conclusions due to the small sample size, it did not identify new safety concerns. However, the sponsor did not seek a pediatric indication due to limited data[3].

Extended-Release Buprenorphine Formulations

A nonrandomized trial evaluated the feasibility of a 7-day extended-release buprenorphine injectable in adult patients with minimal to mild opioid withdrawal. This formulation was found to be acceptable, well-tolerated, and safe, offering a novel method to initiate buprenorphine treatment without the need for stabilization on sublingual buprenorphine[4].

Market Analysis

Current Market Size and Growth

The global buprenorphine market, including transdermal patches, is experiencing significant growth. In 2024, the market size was valued at USD 6.22 billion and is projected to reach USD 35.75 billion by 2037, growing at a compound annual growth rate (CAGR) of 14.4% during the forecast period of 2025-2037[2].

Buprenorphine Transdermal Patches Market

Specifically, the buprenorphine transdermal patches market was valued at USD 1.8 billion in 2023 and is expected to reach USD 24.84 billion by 2030, growing at a CAGR of 16.21% during the forecast period of 2024-2030. This segment is driven by the increasing prevalence of chronic pain disorders, cancer, and opioid addiction, as well as escalating government investments in healthcare[5].

Market Segmentation and Key Players

Segmentation

The buprenorphine transdermal patches market is segmented by type, application, and geography. The sublingual segment currently holds the largest share due to the increasing availability of buprenorphine drugs in this form and its rapid drug absorption. However, the buccal dosage segment is also expected to witness notable growth[2].

Key Players

Leading players in the buprenorphine transdermal patches market include Grunenthal, Purdue Pharma, and Luye Pharma. These companies are driving innovation and expansion in the market through various formulations and distribution strategies[5].

Growth Drivers and Challenges

Growth Drivers

• Increasing Prevalence of Chronic Pain and Cancer: The growing number of patients suffering from chronic pain and cancer is driving the demand for effective pain management solutions like Butrans[2].
• Government Investments in Healthcare: Rising investments in healthcare, especially in developed nations, are supporting the growth of the buprenorphine market[2].
• Opioid Addiction: The escalating issue of opioid addiction worldwide is increasing the demand for buprenorphine as a treatment option[2].

Challenges

• Regulatory Hurdles: The need for stringent regulatory approvals and the implementation of Risk Evaluation and Mitigation Strategies (REMS) can pose challenges to market growth[3].
• Safety Concerns: Potential side effects such as respiratory depression, accidental exposure, and neonatal opioid withdrawal syndrome require careful monitoring and management[3].

Future Projections

Market Expansion

The buprenorphine market, including transdermal patches, is expected to expand significantly over the next decade. The projected growth is driven by the increasing demand for effective pain management and opioid addiction treatment options.

Innovations in Formulations

New formulations such as the 7-day extended-release buprenorphine injectable are expected to enhance patient compliance and access to treatment, further driving market growth[4].

Key Takeaways

• Clinical Efficacy: Butrans has shown efficacy in managing opioid dependence in cancer survivors and is being explored for other patient populations.
• Market Growth: The buprenorphine market, including transdermal patches, is projected to grow significantly due to increasing demand for pain management and opioid addiction treatment.
• Key Players: Companies like Grunenthal, Purdue Pharma, and Luye Pharma are leading the market with innovative products and strategies.
• Challenges: Regulatory hurdles and safety concerns need to be addressed to ensure sustained market growth.

FAQs

What is Butrans used for?

Butrans is used for the management of moderate to severe chronic pain in patients who require around-the-clock opioid analgesia.

What are the key findings from recent clinical trials on Butrans?

Recent trials have shown that Butrans can be effective in managing opioid dependence in cancer survivors and is well-tolerated in patients with minimal to mild opioid withdrawal.

How is the buprenorphine market expected to grow?

The buprenorphine market is expected to reach USD 35.75 billion by 2037, growing at a CAGR of 14.4% from 2025 to 2037.

Who are the leading players in the buprenorphine transdermal patches market?

The leading players include Grunenthal, Purdue Pharma, and Luye Pharma.

What are the main challenges facing the buprenorphine market?

The main challenges include regulatory hurdles, safety concerns such as respiratory depression and accidental exposure, and the need for careful patient monitoring.

Sources

1. Efficacy of transdermal buprenorphine patch for managing physical dependence on prescription opioids in cancer survivors - Academic.oup.com
2. Buprenorphine Market Size & Share, Growth Trends 2037 - Researchnester.com
3. Butrans Pediatric Safety and Utilization Review - FDA - Fda.gov
4. Extended-Release 7-Day Injectable Buprenorphine for Mild Opioid Withdrawal - Jamanetwork.com
5. Buprenorphine Transdermal Patches Market Size, Share, Scope - Verifiedmarketreports.com