Brixadi Reported Lower Adverse Events in Study
A study analyzed FDA safety data comparing reports for the opioid treatment Brixadi to the competitor Sublocade.
Updated on Sept. 22, 2026 in Substance Abuse
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A company-funded study published through February 2025 found that the opioid treatment Brixadi had lower adverse-event reporting rates than the competitor drug Sublocade. The analysis examined 18 months of safety reports submitted to the FDA.
Why it matters
Comparing safety data between competing medications provides important information for clinicians and patients navigating opioid use disorder treatments. The study highlights differences in reported experiences during the initial post-market periods for both drugs.
Researchers found a withdrawal syndrome reporting rate of 5.7 per 1,000 patients for Brixadi, compared to 40.6 per 1,000 patients for Sublocade. The study analyzed 1,038 Brixadi case reports and 1,844 Sublocade reports.
The players
Braeburn
Braeburn is a pharmaceutical company that specializes in developing long-acting treatments for opioid use disorder.
Food and Drug Administration
The Food and Drug Administration is the federal agency responsible for protecting public health by ensuring the safety and efficacy of medical products.
The details
Researchers at Braeburn examined reports from the Food and Drug Administration Adverse Event Reporting System to track patient safety. The findings identified withdrawal syndrome and injection-site pain as the most frequently reported adverse events for both medications.
Timeline
March 2018 - August 2019: Study period for Sublocade adverse-event reports.
September 2023 - February 2025: Study period for Brixadi adverse-event reports.
The Big Picture
This study relies on the Food and Drug Administration Adverse Event Reporting System as its primary data repository. The analysis follows established patterns of using this federal database to evaluate medication safety profiles after they enter the national market.
Patients may use these findings to discuss potential side effects and treatment options with their healthcare providers. Understanding the reported frequency of events like injection-site pain can help individuals make more informed decisions about their care.
The takeaway
Clinicians and patients should review comparative safety data when evaluating opioid use disorder treatment options. This study emphasizes the importance of utilizing post-market safety reports to monitor medication performance in real-world settings.
Further reading
Find more information on treatments in the Substance Abuse section.
More information
Read the full research study00215-8/fulltext) for complete data findings.
Source note: This article includes information reported by MyChesCo.
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