Braeburn’s BRIXADI Shows Promise Against Fentanyl in Opioid Use Disorder Study


PLYMOUTH MEETING, PA — Braeburn Inc. has announced the recent tpublication of a post hoc analysis in JAMA Network Open, revealing promising results for its drug BRIXADI in the fight against fentanyl use among patients with opioid use disorder (OUD). The analysis stems from a Phase 3 Clinical Efficacy and Safety trial comparing BRIXADI, an extended-release buprenorphine injection, to daily sublingual buprenorphine/naloxone (SL BPN/NX).

“Fentanyl is a primary driver of the continued growth of the opioid epidemic. The findings support prior observational studies that buprenorphine is effective against fentanyl, and is consistent with evidence from the BRIXADI Phase 3 Study,” said Dr. Edward V. Nunes, Professor of Psychiatry at Columbia University Irving Medical Center. “Further research is needed to assess the efficacy of medications for OUD in the current landscape.”

The Phase 3 study was conducted over 24 weeks at 35 outpatient clinical centers in the U.S., involving 123 participants who showed evidence of fentanyl use. This subgroup included 64 patients on BRIXADI and 59 on SL BPN/NX. The research aimed to mirror the patient population typically seen with moderate to severe OUD.

Key Findings from the Post Hoc Analysis:
  • Urine Toxicology Results: In the fentanyl-positive subgroup, 74.6% of urine samples from the BRIXADI arm tested negative for fentanyl compared to 61.9% from the SL BPN/NX arm.
  • Opioid Use Reduction: The percentage of urine samples negative for opioids was 28.5% in the BRIXADI group versus 18.8% in the SL BPN/NX group for those positive for fentanyl. In fentanyl-negative participants, BRIXADI showed 36.7% of samples negative for opioids compared to 30.6% for SL BPN/NX.
  • Study Completion Rates: Completion rates were similar between fentanyl-positive and fentanyl-negative groups, at 60.2% and 56.7%, respectively.
  • Adverse Events: Common side effects included injection-site reactions like swelling and inflammation. Three nonfatal heroin overdoses were reported, all in the SL BPN/NX group.
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While the analysis provides encouraging data, it also has limitations. The parent trial did not specifically aim to differentiate treatment responses based on fentanyl use, and most patients were using heroin mixed with fentanyl.

The full study, titled “Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder with Fentanyl Use,” is available on JAMA Network Open.

This new data highlights BRIXADI’s potential in addressing the complex challenge of fentanyl use in OUD treatment, offering hope amid the ongoing opioid crisis.

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