NDASUBCUTANEOUSSOLUTION, EXTENDED RELEASEPriority Review
Approved
May 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
BRIXADI (buprenorphine) by Braeburn Pharmaceuticals is partial opioid agonists [moa]. First approved in 2023.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BRIXADI is a subcutaneous, extended-release formulation of buprenorphine, a partial opioid agonist approved in May 2023 by the FDA. It is indicated for opioid use disorder treatment, offering extended dosing convenience compared to traditional daily formulations. The partial agonist mechanism provides both therapeutic efficacy and safety by reducing overdose risk.
$0.363MPart D
Peak6.1 years to LOEEarly peak-stage adoption with modest Part D penetration signals a growing but still-maturing market opportunity, with room for field team expansion.
Mechanism of Action
Partial Opioid Agonists
Pharmacologic Class:
Partial Opioid Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic
Started Apr 2026
60 enrolled
Opioid Use Disorder
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
Started Dec 2025
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine
Started Jan 2025
60 enrolled
Opioid Use Disorder
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Started Jan 2025
32 enrolled
Healthy Volunteer Study
An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders
Started Jan 2025
60 enrolled
Autism Spectrum Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.