PLYMOUTH MEETING, Pa., April 6, 2019 /PRNewswire/ -- Braeburn Inc. announces positive post-hoc analyses results from the randomized, double-blind, double-dummy Phase 3 study of BRIXADI™ (buprenorphine) extended-release weekly and monthly injections for the treatment of opioid use disorder (OUD) in patients who tested positive for fentanyl prior to treatment initiation. The results were presented today at the American Society of Addiction Medicine Annual Conference in Orlando.
Results demonstrate that, consistent with primary and secondary endpoints of the total study population and previous post-hoc analyses of subgroups reporting heroin or intravenous drug use prior to initiation, treatment with BRIXADI resulted in a greater percentage of urine samples negative for illicit opioids in patients with evidence of fentanyl use prior to initiation as compared to sublingual buprenorphine/naloxone (SL BPN/NX). Additionally, there was a trend towards lower withdrawal scores as measured by the Clinical Opioid Withdrawal Scale (COWS) and lower craving scores as measured by the Need to Use Visual Analog Scale (VAS) with BRIXADI compared to SL BPN/NX for patients with evidence of fentanyl use prior to initiation.
"Fentanyl has been implicated in the rapid increase of opioid overdose fatalities, with over 28,400 U.S. deaths each year attributed to fentanyl and other synthetic narcotics, according to the Centers for Disease Control," said Edward V. Nunes, M.D., Professor of Psychiatry at Columbia University Medical Center, who presented the results of the post-hoc analyses of the Phase 3 study at the American Society of Addiction Medicine Annual Conference. "Our analyses indicate that patients with fentanyl exposure prior to randomization are difficult to treat but seem to use less illicit opioids and fentanyl if treated with weekly and monthly BRIXADI than with standard daily treatment with SL BPN/NX.1 These positive results validate the potential for this product to meet real-world needs."
In the pivotal Phase 3 study, published in JAMA Internal Medicine in May of 2018, BRIXADI demonstrated noninferiority for the proportion of patients with no evidence of illicit opioid use and met superiority on the cumulative distribution function (CDF) for the percent of negative illicit opioid assessments with comparable systemic safety as compared to SL BPN/NX. With the exception of injection site adverse events (AEs), the safety profile observed with BRIXADI was consistent with the known safety profile of SL BPN/NX with no unexpected AEs observed. No fatal or non-fatal overdoses were observed for patients treated with BRIXADI in the study.
About BRIXADI (buprenorphine) Extended Release Injection for SC Use (CIII)
BRIXADI is an extended-release weekly (8mg, 16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) injection used for the treatment of moderate to severe OUD. BRIXADI is tentatively approved by the FDA for patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. BRIXADI will be administered only by healthcare providers (HCPs) in a healthcare setting and used as part of a complete treatment program that includes counseling and psychosocial support.
Braeburn is dedicated to delivering solutions for people living with the serious, often fatal consequences of opioid addiction. Our mission is to advance a portfolio of next-generation therapies, with individualized dosing regimens and delivery options, to address the escalating disease burden of addiction faced by patients, HCPs, payers and society. For more information about Braeburn, please visit www.braeburnrx.com.
1. Edward V Nunes et al. Correlates Of Fentanyl Use In A Controlled Trial Of Injectable Weekly/Monthly Buprenorphine. Presented at the 50th Annual Conference of the American Society of Addiction Medicine, 4–7 April 2018, Orlando, Florida, US.
For additional information, please contact:
Colleen Saltmer: [email protected]