Treatment characteristics and safety profiles of Belbuca®, buprenorphine patch, and oral schedule II opioids among chronic low back pain patients without a positive history of opioid-use disorder: a retrospective US commercial claims analysis.

Authors

Vladimir Zah, Dimitrije Grbic, Filip Stanicic

Published in

Frontiers in pain research (Lausanne, Switzerland). Volume 7. Pages 1764842. Epub Jun 30, 2026.

Abstract

The objective of this retrospective study was to evaluate and compare the safety characteristics of patients with chronic low back pain (cLBP) without a recent positive history of opioid use disorder (OUD).
This study was conducted using the Merative MarketScan® database (January 2019-December 2023). The first date of Belbuca®, buprenorphine patch, or oral schedule II (CII) opioid prescription was designated as the index date. The observational period covered a 6-month preindex period and a follow-up period that lasted until the end of index treatment or continuous healthcare coverage. Patients were required to have two low back pain diagnoses and no OUD in the preindex period and continuous healthcare coverage during the observational period. The 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 for TEAEs occurring in one cohort. Propensity-score matching was employed to balance differences in patient characteristics and minimize their impact on study outcomes.
There were no serious TEAEs associated with higher occurrence in the Belbuca® cohort compared with oral CII opioids. Belbuca® treatment was associated with a significantly lower rate 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). The subanalysis compared incidence rates of serious TEAEs between Belbuca® and buprenorphine patch cohorts. Belbuca® demonstrated 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). However, the 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).
The study findings suggest 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.

PMID:
42454247
Bibliographic data and abstract were imported from PubMed on 15 Jul 2026.

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