(267) Post-launch adverse events reported to FDA adverse event reporting system for long-acting injectable buprenorphine

Background: : Two long-acting injectable (LAI) buprenorphine medications have received US Food and Drug Administration (FDA) approval for the treatment of moderate to severe opioid use disorder (OUD): SUBLOCADE (BUP-SB, monthly) and BRIXADI (BUP-BX, weekly and monthly).

Post-marketing data are valuable for understanding the safety of these medications in the real-world with populations not necessarily represented in the clinical trial setting.

The FDA Adverse Event Reporting System (FAERS) is a centralized, computerized information database used for post-marketing drug safety surveillance and adverse event (AE) signal detection.

Objective: : The primary objective of this study was to determine AE reporting rates (RR) for BUP-SB and BUP-BX in the first 12 months following their commercial launches in the United States (US).

Methods: : This retrospective analysis evaluated AEs spontaneously reported to FAERS during the 12-month periods following US commercial launches of BUP-SB (March 1, 2018 to February 28, 2019) and BUP-BX (September 5, 2023 to September 4, 2024). RR was determined using the total number of AE reports containing a specific Medical Dictionary for Regulatory Activities (MedDRA) AE Preferred Term (PT) per 1000 patients treated (RRpt) and per 1000 units sold (RRrx). AEs with an RR ≥1 for at least one of the products were reported.

Results: : A total of 799 and 393 AE reports were received for BUP-SB and BUP-BX, respectively, during the first 12 months post-launch. The estimated number of patients treated with BUP-SB and BUP-BX during these periods was 6,464 and 24,805, with an estimated 16,770 and 94,826 units sold.

AEs meeting the frequency threshold for RRrx (RR ≥1 for either product per 1000 units sold) were as follows for BUP-SB and BUP-BX: “withdrawal syndrome”: 15.1 and 1.1, “injection site pain”: 15.0 and 0.3, “drug dependence”: 3.5 and 0.2, “injection site erythema”: 3.0 and 0.2, “injection site discharge”: 3.0 and 0.0, “drug abuse”: 2.6 and 0.0, and “nausea”: 2.4 and 0.2.

Results for AEs meeting the frequency threshold for RRpt (RR ≥1 for either product per 1000 patients treated) were similar.

Conclusions: : Overall, AEs associated with both BUP-SB and BUP-BX were infrequent during the 12-month periods following their US commercial launches.

These data provide insights into the real-world safety profile of LAI buprenorphine medications for the treatment of moderate to severe OUD and may help inform clinical decision-making.

Sponsorship:: Braeburn Inc.