Brixadi Adverse Event Reports Trailed Sublocade, Study Found
A new company-funded study compared postmarketing safety reports for two buprenorphine treatments in the U.S.
Updated on Sept. 22, 2026 in Substance Abuse
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Researchers recently analyzed adverse-event reports submitted to the FDA from September 2023 through February 2025. The study examined safety data for patients using the injectable treatment Brixadi compared to the established drug Sublocade.
Why it matters
Understanding the comparative safety profiles of long-acting buprenorphine formulations helps patients and physicians evaluate potential treatment options for opioid use disorder. This study provides a retrospective look at how frequently side effects were reported during the initial market rollout.
This retrospective analysis of FAERS data compared 18 months of safety reporting for Brixadi against the same duration for Sublocade. The study, funded by Braeburn, analyzed data from 45,161 Brixadi patients and 13,120 Sublocade patients.
The players
Braeburn
A pharmaceutical company that focuses on developing long-acting therapies for the treatment of opioid use disorder.
Food and Drug Administration
The federal agency responsible for regulating safety standards for pharmaceuticals sold in the United States.
The details
Researchers calculated reporting rates by normalizing case reports against the total estimated number of patients treated and units sold. For both medications, withdrawal syndrome and injection-site pain were the most frequently recorded adverse-event terms. The study observed that overall reporting rates remained lower for the Brixadi cohort throughout the evaluated timeframe.
Timeline
March 2018 - August 2019: Study period for Sublocade adverse-event reports.
September 2023 - February 2025: Study period for Brixadi adverse-event reports.
Health Landscape
Postmarketing safety surveillance is a critical tool for identifying side effects that were not apparent during original clinical trials. This study sits within the broader effort to refine long-term care strategies for patients managing opioid use disorder with injectable formulations.
If you are currently prescribed an injectable buprenorphine treatment, any new or concerning symptoms should be discussed with your physician. Tracking your own experiences with side effects is a valuable part of the ongoing conversation with your healthcare provider.
The takeaway
While this study noted lower reporting rates for one medication, it is important to remember that such findings reflect reported data rather than individual outcomes. Patients should prioritize consistent communication with their doctor to manage treatment side effects and overall care goals.
Further reading
For more context on managing treatment options, see Substance Abuse.
More information
You can review the full research study00215-8/fulltext) for a detailed breakdown of the reported safety data.
Source note: This article includes information reported by MyChesCo.
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