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35th AM (2025) - Poster Session
Post-Launch Adverse Events Reported to FDA Adverse ...
Post-Launch Adverse Events Reported to FDA Adverse Event Reporting System for Long-Acting Injectable Buprenorphine
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Pdf Summary
This retrospective analysis assessed adverse events (AEs) reported to the FDA Adverse Event Reporting System (FAERS) for two long-acting injectable buprenorphine (LAIB) formulations, RBP-6000 and CAM2038, used to treat moderate to severe opioid use disorder (OUD). The study covered the first 18 months post-commercial launch in the US for each product: RBP-6000 from March 2018 to August 2019 and CAM2038 from September 2023 projected to February 2025.<br /><br />An estimated 13,120 patients received RBP-6000 and 45,161 received CAM2038 during these periods. There were 3,192 AEs reported for RBP-6000 and 1,725 for CAM2038. Reporting rates (RR) per 1,000 patients treated revealed the most frequently reported events included withdrawal syndrome, injection site pain, drug dependence, injection site erythema, nausea, drug abuse, and therapeutic product effect. For example, withdrawal syndrome was reported at a rate of 33.54 per 1,000 patients for RBP-6000 and 4.87 for CAM2038.<br /><br />Limitations noted include the inherent uncertainty in spontaneously reported FAERS data regarding causality, possible underreporting of AEs, and the potential influence of the Weber effect (increased reporting soon after drug launch), although the latter may be less relevant for FAERS data. Patient number estimates were derived from publicly available and distributor data, which may have data capture limitations.<br /><br />Overall, the AE incidence for both LAIBs was low and consistent with prior clinical trial safety profiles. These findings offer valuable real-world safety insights for clinicians considering LAIB options in managing moderate to severe OUD, complementing existing evidence from controlled studies. The authors disclosed various professional relationships with Braeburn Inc., a manufacturer of these products.
Keywords
Buprenorphine
Long-acting injectable
Opioid use disorder
Adverse events
FDA Adverse Event Reporting System
RBP-6000
CAM2038
Withdrawal syndrome
Injection site pain
Drug dependence
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