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