Objective:

To evaluate and compare the safety characteristics of Belbuca®, buprenorphine patch, and oral schedule II opioids in patients with chronic low back pain (cLBP) without a recent positive history of opioid use disorder (OUD).

Approach:

• Study Design: Retrospective study using the Merative MarketScan® database from January 2019 to December 2023.
• Patient Selection: Patients required two low back pain diagnoses, no OUD in the preindex period, and continuous healthcare coverage.
• Outcome Measures: Primary outcomes were serious treatment-emergent adverse event (TEAE) rates reported as incidence rate ratios (IRR) or absolute incidence rate difference (IRD) per 1,000 person-years.
• Statistical Analysis: Propensity-score matching was employed to balance differences in patient characteristics.

Key Findings:

• No serious TEAEs were associated with higher occurrence in the Belbuca® cohort compared to oral CII opioids.
• Belbuca® treatment showed significantly lower rates of serious opioid abuse/dependence (IRD −33.76 per 1,000 person-years, p = 0.032), osteoarthritis (IRD −78.77 per 1,000 person-years, p = 0.001), urinary discomfort (IRD −146.28 per 1,000 person-years, p < 0.001), seizures (IRR 0.11, p = 0.019), dehydration (IRR 0.13, p = 0.003), abdominal pain (IRR 0.25, p < 0.001), and nausea/vomiting (IRR 0.30, p = 0.001).
• Belbuca® had higher rates of serious coronary artery disease (IRD 39.01 per 1,000 person-years, p = 0.035), cholecystitis (IRD 39.01 per 1,000 person-years, p = 0.035), and headache (IRD 39.01 per 1,000 person-years, p = 0.035) compared to buprenorphine patch.
• Buprenorphine patch cohort had higher incidence rates of serious QT prolongation (IRD −52.78 per 1,000 person-years, p = 0.009), opioid abuse/dependence (IRD −184.75 per 1,000 person-years, p < 0.001), confusion (IRR 0.10, p = 0.007), hypertension (IRR 0.22, p = 0.043), and cellulitis (IRR 0.41, p = 0.011).

Interpretation:

Belbuca® may have a favorable safety profile relative to oral CII opioids and buprenorphine patch treatments in cLBP patients without a positive history of OUD.

Limitations:

• Retrospective design may introduce bias, limiting the ability to establish causality.
• Data sourced from a commercial claims database may not be generalizable to all populations.

Conclusion:

The study findings indicate that Belbuca® may have a favorable safety profile relative to oral CII opioids and buprenorphine patch treatments in cLBP patients without a positive history of OUD.