Braeburn Announces Publication of Phase 3 Study Results Showing Long-term Safety and Effectiveness of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder
PLYMOUTH MEETING, Pa., June 4, 2019 -- (PRNewswire) -- Braeburn Inc. announces the publication of its 48-week, open-label, multi-center, global Phase 3 long-term safety study of once weekly and once monthly BRIXADI in a leading substance use disorder journal, Addiction. The study evaluated the long-term safety of BRIXADI, as well as other measures of effectiveness in both new-to-treatment patients and patients transferring from daily standard-of-care with sublingual buprenorphine or buprenorphine/naloxone.
"The results of this study demonstrate a real-world application of an injectable extended-release buprenorphine in patients both new-to-treatment and patients already stabilized on a daily dose of oral buprenorphine," said Mike Frost, MD, FACP, FASAM, President of Frost Medical Group and Primary Investigator for this study. "Additionally, the variety of doses and interchangeability of weekly and monthly formulations as utilized in this study provide important options for clinicians who want to individualize doses and to titrate down doses for evolving patient needs throughout the treatment duration."
The study enrolled 227 patients from 26 clinical sites across the United States, the United Kingdom, Hungary, Denmark, Sweden, Germany and Australia. In total, 167 patients (73.6%) completed the 48 weeks of treatment, with over 5,000 injections of BRIXADI administered. More than 80% of the patients who transitioned from daily sublingual buprenorphine treatment stated that BRIXADI was "much better" or "slightly better" than their previous treatment. Furthermore, BRIXADI weekly and monthly were effective in reducing opioid withdrawal and cravings and maintaining low withdrawal and craving scores. The degree of abstinence at the end of the treatment period was high, with 63.0% (17/37) of new-to-treatment participants and 82.8% (111/190) of patients converted from sublingual buprenorphine having negative urine tests plus negative self-reports for illicit opioid use.
Additionally, BRIXADI was well tolerated and demonstrated a systemic safety profile similar to sublingual buprenorphine. The most common adverse events (AEs) occurring in ≥5% of participants were pain, swelling, or erythema at the injection site; nasopharyngitis; headache; nausea; urinary tract infection; and vomiting. Injection site reactions were reported for 20.3% of patients, with most (97.8%) reported as mild to moderate. Serious AEs were experienced by 5.3% of patients of which none were related to study medication. As in the Phase 3 efficacy study, no opioid overdoses were reported for patients treated with BRIXADI.
"We are pleased to see consistent results from this study supporting the long-term safety of BRIXADI weekly and monthly," said Mike Derkacz, President and CEO of Braeburn. "This study demonstrates important features of BRIXADI including the ability for healthcare providers to transition patients currently on a range of daily oral treatment to a corresponding dose of BRIXADI weekly or monthly while maintaining stability of treatment."
The full manuscript titled, "Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult outpatients with opioid use disorder" is available online in Addiction today.
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 opioid use disorder. 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 https://www.braeburnrx.com/.
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