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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR BELBUCA


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All Clinical Trials for Belbuca

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00941304 ↗ Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain Completed BioDelivery Sciences International Phase 2 2009-08-01 The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.
NCT00941304 ↗ Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain Completed Endo Pharmaceuticals Phase 2 2009-08-01 The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.
NCT01256450 ↗ Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain Completed BioDelivery Sciences International Phase 3 2010-11-01 The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).
NCT01256450 ↗ Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain Completed Endo Pharmaceuticals Phase 3 2010-11-01 The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).
NCT01633944 ↗ Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects Completed BioDelivery Sciences International Phase 3 2012-08-01 The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.
NCT01633944 ↗ Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects Completed Endo Pharmaceuticals Phase 3 2012-08-01 The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Belbuca

Condition Name

Condition Name for Belbuca
Intervention Trials
Low Back Pain 3
Pain 2
Ventilatory Response to Hypercapnia (VRH) 1
Back Pain Lower Back Chronic 1
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Condition MeSH

Condition MeSH for Belbuca
Intervention Trials
Low Back Pain 4
Back Pain 4
Opioid-Related Disorders 1
Chronic Pain 1
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Clinical Trial Locations for Belbuca

Trials by Country

Trials by Country for Belbuca
Location Trials
United States 73
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Trials by US State

Trials by US State for Belbuca
Location Trials
Utah 6
Pennsylvania 4
North Carolina 4
Kansas 4
Texas 4
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Clinical Trial Progress for Belbuca

Clinical Trial Phase

Clinical Trial Phase for Belbuca
Clinical Trial Phase Trials
Phase 4 2
Phase 3 3
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Belbuca
Clinical Trial Phase Trials
Completed 7
Recruiting 2
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Clinical Trial Sponsors for Belbuca

Sponsor Name

Sponsor Name for Belbuca
Sponsor Trials
BioDelivery Sciences International 9
Endo Pharmaceuticals 5
Carolinas Pain Institute 1
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Sponsor Type

Sponsor Type for Belbuca
Sponsor Trials
Industry 16
Other 2
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Belbuca: Clinical Trials, Market Analysis, and Projections

Introduction to Belbuca

Belbuca, a buprenorphine buccal film, is a Schedule III opioid approved by the U.S. Food and Drug Administration (FDA) in October 2015 for the management of chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment, where alternative treatment options are inadequate[3].

Clinical Trials and Safety Profile

Phase I Clinical Trial on Respiratory Drive

A significant Phase I clinical trial presented at the American Academy of Pain Medicine’s 36th Annual Meeting compared the effects of Belbuca and oral oxycodone hydrochloride on respiratory drive. The study involved healthy males and females who were not physically dependent on opioids and used a double-blind, double-dummy design to assess the ventilatory response to hypercapnia.

  • The results showed that Belbuca’s effect on respiratory drive was comparable to placebo at all tested doses, whereas oral oxycodone hydrochloride resulted in a dose-dependent decrease in respiratory drive compared to placebo. This study supports the use of Belbuca as a safer option for managing chronic pain due to its minimal impact on respiratory drive[1].

Safety Comparison with Oral Opioids

A retrospective analysis using the MarketScan Commercial database compared the safety profiles of Belbuca, buprenorphine transdermal patches, and oral opioids in treating chronic low back pain. The study found that buprenorphine, particularly Belbuca, had lower rates of serious treatment-emergent adverse events (TEAEs) compared to oral opioids. However, Belbuca was associated with higher rates of serious dizziness and cholecystitis. Overall, Belbuca demonstrated a more favorable safety profile than both oral opioids and buprenorphine transdermal patches[4].

Market Analysis

Current Market Size and Growth

The chronic pain market, which includes treatments like Belbuca, has been growing steadily. As of 2023, the chronic pain market size was valued at USD 21.2 billion and is projected to reach USD 28.9 billion by 2034, driven by the escalating need for over-the-counter and prescription medications[2].

Market Positioning of Belbuca

BioDelivery Sciences, the company behind Belbuca, has been actively expanding the clinical understanding and application of this drug. Recent updates have highlighted Belbuca’s effectiveness and safety profile, particularly in managing chronic pain in patients with opioid-induced constipation (OIC) and those transitioning from higher-dose opioids. These developments have strengthened Belbuca’s market positioning as a preferred treatment option for chronic pain management[2].

Projections and Future Outlook

Market Growth Drivers

The growth of the chronic pain market, and by extension the demand for Belbuca, is driven by several factors:

  • Increasing Prevalence of Chronic Pain: The rising number of individuals suffering from chronic pain conditions is a significant driver.
  • Advancements in Treatment Options: Continuous research and development in pain management, including the use of buprenorphine, are expanding treatment options.
  • Regulatory Support: Recommendations from bodies like the Pain Management Best Practices Inter-Agency Task Force to conduct more research on buprenorphine support the growth of Belbuca and similar treatments[1][2].

Competitive Landscape

The opioid use disorder treatment market, which includes Belbuca, is expected to expand significantly. By 2035, this market is estimated to reach USD 14.36 billion, with a robust CAGR of 9.75% between 2025 and 2035. North America is currently the largest market, while the Asia Pacific region is expected to be the fastest-growing market[5].

Key Takeaways

  • Clinical Safety: Belbuca has demonstrated a favorable safety profile, particularly in terms of respiratory drive and overall adverse event rates compared to oral opioids.
  • Market Growth: The chronic pain market is projected to grow significantly, driven by the need for effective and safe treatment options.
  • Market Positioning: Belbuca is well-positioned as a primary treatment option for chronic pain management, especially for patients transitioning from higher-dose opioids or those with opioid-induced constipation.
  • Future Outlook: The opioid use disorder treatment market, including Belbuca, is expected to see substantial growth, driven by increasing prevalence and regulatory support.

FAQs

What is Belbuca used for?

Belbuca is used for the management of chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment, where alternative treatment options are inadequate[3].

How does Belbuca compare to oral oxycodone in terms of respiratory drive?

Belbuca’s effect on respiratory drive is comparable to placebo at all tested doses, whereas oral oxycodone hydrochloride results in a dose-dependent decrease in respiratory drive compared to placebo[1].

What are the key safety findings of Belbuca compared to other opioids?

Belbuca has lower rates of serious treatment-emergent adverse events compared to oral opioids but is associated with higher rates of serious dizziness and cholecystitis[4].

What is the projected market size for the chronic pain market by 2034?

The chronic pain market is expected to reach USD 28.9 billion by 2034[2].

How is the opioid use disorder treatment market expected to grow?

The opioid use disorder treatment market is expected to reach USD 14.36 billion by 2035, with a CAGR of 9.75% between 2025 and 2035[5].

Sources

  1. BioDelivery Sciences Announces Phase I Clinical Trial Results at the American Academy of Pain Medicine’s 36th Annual Meeting. BioSpace.
  2. Chronic Pain Market Size to Reach USD 28.9 Billion by 2034. BioSpace.
  3. Endo Announces Launch Of BELBUCA™ (Buprenorphine) Buccal Film for Chronic Pain Management. PR Newswire.
  4. Serious treatment-emergent adverse events in chronic low back pain treated with buprenorphine buccal film, buprenorphine transdermal patches, or oral opioids. PubMed.
  5. Opioid Use Disorder Treatment Market Share & Size 2025-2035. MetaTech Insights.

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