Braeburn Publishes Post Hoc Analysis on BRIXADI Phase 3 Study with Fentanyl Patients

PLYMOUTH MEETING, Pa., June 25, 2024  -- Braeburn Inc. has announced the release of a post hoc analysis in the Journal of the American Medical Association (JAMA) Network Open. This analysis reviewed data from patients exhibiting fentanyl use in a Phase 3 Clinical Efficacy and Safety trial. The trial compared BRIXADI (buprenorphine) extended-release injection for subcutaneous use with daily sublingual buprenorphine/naloxone (SL BPN/NX) in patients dealing with moderate to severe opioid use disorder (OUD).

Edward V. Nunes, M.D., a Professor of Psychiatry at Columbia University Irving Medical Center, emphasized the significance of these findings. He remarked that fentanyl is a significant contributor to the opioid epidemic and that the findings align with previous studies showing buprenorphine's effectiveness against fentanyl. However, he called for further studies to fully understand the efficacy of medications for OUD in the current opioid landscape.

The Phase 3 trial lasted 24 weeks and was randomized, double-blind, and active-controlled, involving multiple centers. Conducted in 35 outpatient clinical centers in the U.S., the post hoc analysis focused on a subgroup of 123 participants (64 in the BRIXADI group and 59 in the SL BPN/NX group) who had baseline evidence of fentanyl use. The trial included participants typical of those suffering from moderate to severe OUD.

Key points from the Post Hoc Analysis included:

- Assessments involved urine toxicology for illicit opioid use (including fentanyl), Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), Visual Analog Scale (VAS), and adverse events (AEs).
- In the fentanyl-positive subgroup, 74.6% of urine samples from the BRIXADI group were negative for fentanyl, compared to 61.9% in the SL BPN/NX group.
- For overall opioid negativity in urine samples, the BRIXADI group showed 28.5% compared to 18.8% in the SL BPN/NX group in the fentanyl-positive subgroup.
- In the fentanyl-negative subgroup, 36.7% of urine samples from the BRIXADI group were opioid-negative compared to 30.6% for the SL BPN/NX group.
- Study completion rates were similar between the fentanyl-positive (60.2%) and fentanyl-negative (56.7%) subgroups.
- Adverse events were consistent with known safety profiles of buprenorphine, except for injection-site issues like swelling and inflammation. Three nonfatal heroin overdoses were reported in the study, occurring in the SL BPN/NX group.

However, the post hoc analysis had limitations. Most participants were using heroin mixed with fentanyl, and the analysis was not initially planned. The main trial didn't aim to differentiate treatment responses between subgroups, and varying outcomes might be due to overall disease severity rather than fentanyl use specifically.

Natalie R. Budilovsky-Kelley, PharmD, Senior Director of Medical Affairs at Braeburn, highlighted this as the first study to specifically evaluate patients testing positive for fentanyl in a Phase 3 trial comparing long-acting buprenorphine with SL BPN/NX for OUD treatment. She noted that these findings add valuable insights into treating patients with OUD who use fentanyl.

The detailed publication, "Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder with Fentanyl Use," is accessible online at JAMA Network Open.

Joshua M. Cohen, MD, MPH, FAHS, Chief Medical Officer at Braeburn, expressed gratitude for the collaboration with researchers committed to addressing the opioid crisis and emphasized Braeburn's dedication to advancing scientific understanding in OUD treatment.

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