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MEETING OF PLYMOUTH, Pa., April 6, 2019 / PRNewswire / – Braeburn Inc. Announces Positive Results from Post-hoc Analyzes of the Double-Blind, Randomized, Phase 3, BRIXADI ™ (buprenorphine) Extended-Release Phase 3 Trial for Patients the treatment of opioid disorder in patients who tested positive for fentanyl prior to initiation of treatment. The findings were presented today at the annual conference of the American Society of Addiction Medicine at Orlando.
The results demonstrate that, in accordance with the primary and secondary endpoints of the total study population and previous post-hoc badyzes of subgroups reporting heroin or intravenous drug use prior to At the start of treatment, treatment with BRIXADI resulted in a higher percentage of urine samples negative for illicit opioids in patients. with evidence of fentanyl use prior to initiation versus buprenorphine / sublingual naloxone (SL BPN / NX). In addition, there was a trend towards lower weaning scores as measured by the Clinical Opioid Withdrawal Scale (COWS) and lower craving scores as measured by the scale of depression. Analog visual use (EVA) with BRIXADI compared to SL BPN / NX for patients with evidence. fentanyl before initiation.
"Fentanyl has been implicated in the rapid increase in the number of overdose opioid deaths, with more than 28,400 US deaths each year attributed to fentanyl and other synthetic narcotics, according to the Centers. for Disease Control, "said the Center for Disease Control. Edward V. Nunes, M.D., professor of psychiatry at Columbia University Medical Center, which presented the results of the post-hoc badyzes of the Phase 3 study at the annual conference of the American Society of Addiction Medicine. "Our badyzes indicate that patients exposed to fentanyl prior to randomization are difficult to treat but appear to use fewer illicit opioids and fentanyl if they are treated with BRIXADI once a week and month than before." with standard daily treatment with SL BPN / NX.1 These positive results confirm the potential of this product to meet the needs of the real world. "
In the pivotal phase 3 study, published in JAMA Internal Medicine in May 2018, BRIXADI demonstrated non-inferiority for the proportion of patients for whom there was no evidence of misuse of opioids and a superiority over the cumulative distribution function (CDF) for the percentage of negative opioid evaluations negative with a systemic safety comparable to that of BPN / NX SL. . With the exception of adverse events at the injection site (AE), the safety profile observed with BRIXADI was consistent with the known safety profile of BPN / NX SL and no unexpected AEs has not been observed. No lethal or non-fatal overdose was observed in patients treated with BRIXADI during the study.
About BRIXADI (buprenorphine) Sustained-release injection for subcutaneous use (CIII)
BRIXADI is a weekly (8 mg, 16 mg, 24 mg, 32 mg) and monthly (64 mg, 96 mg, 128 mg) sustained release injection used for the treatment of moderate to severe SUV. BRIXADI is provisionally approved by the FDA for patients who have started treatment with a single dose of a transmucosal product based on buprenorphine or who are already being treated with buprenorphine. BRIXADI will be administered solely by health care providers in a health care facility and used as part of a comprehensive treatment program including counseling and psychosocial support.
About Braeburn
Braeburn is dedicated to providing solutions to 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 growing burden of addiction for patients, health professionals, payers and of the society. For more information on Braeburn, visit www.braeburnrx.com.
References
1. Edward V Nunes et al. Correlates of the Use of Fentanyl in a Controlled Trial of Buprenorphine Injectable Weekly / Monthly. Presented at the 50th Annual Conference of the American Society of Addiction Medicine, April 4-7, 2018, Orlando Florida, US.
For more information, please contact:
Colleen Saltmer: [email protected]
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