Le Lézard
Classified in: Health
Subject: FDA

FDA Accepts Braeburn's New Drug Application Resubmission for BRIXADItm (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

PLYMOUTH MEETING, Pa., June 26, 2021 /PRNewswire/ -- Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was accepted by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) action date is set for December 15, 2021. 


"We are pleased that the FDA has accepted our application for BRIXADI," said Mike Derkacz, President and CEO of Braeburn. "We look forward to working with the FDA to advance BRIXADI toward approval and to providing another option for healthcare providers to treat their patients with opioid use disorder, a disease that continues to have a devastating impact on patients, their loved ones, and communities." 

About BRIXADI (buprenorphine) Extended-Release Injection for SC Use (CIII) 

BRIXADI is an investigational, extended-release weekly (8mg, 16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) injection for subcutaneous use that is under review by FDA for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. If approved, BRIXADI would be used as part of a complete treatment plan to include counseling and psychosocial support. BRIXADI will be available through a Risk Evaluation and Mitigation Strategy (REMS) program and administered only by healthcare providers in a healthcare setting. 

During the clinical development program, the safety profile of BRIXADI was generally consistent with the known safety profile of oral buprenorphine with the exception of mild-to-moderate injection-site reactions. The most common adverse reactions (occurring in ?5% of patients) associated with BRIXADI administration included injection-site pain, headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia and urinary tract infections. 

About Braeburn 

Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. Our mission is to advance next-generation therapies, with individualized dosing regimens and delivery options, to address the escalating disease burden of opioid use disorder faced by patients, healthcare professionals, payers and society. For more information about Braeburn, please visit https://braeburnrx.com

For additional information, please contact: 

Colleen Saltmer: csaltmer@braeburnrx.com  

SOURCE Braeburn

These press releases may also interest you

at 05:30
The self-inflating bag market size is set to grow by USD 71.79 mn from 2020 to 2024, at a CAGR of 5% according to the latest market report by Technavio. ...

at 05:00
Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to improve treatment outcomes, today announced it has entered into a clinical trial collaboration agreement...

at 04:39
Redwood Pharma announces today a strategic move to accelerate development of RP501, the company's IntelliGel-based topical first-line therapy for dry eye disease. While RP101 remains a clinically tested and unique candidate drug for post-menopausal...

at 04:35
The global qPCR instruments market size is expected to reach USD 1.39 billion by 2028, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 3.4% from 2021 to 2028. The market is driven by the introduction of...

at 04:30
The Olon Group announces the creation of an international network of scientific excellence to launch large-scale biocatalysis as an industrial technology used within its production facilities in Italy and around the world. The partnership, bringing...

at 04:13
The National Comprehensive Cancer Network® (NCCN®)?an alliance of leading cancer centers in the United States?today announced the publication of new NCCN Guidelines® for Cervical Cancer: Poland Edition. This is the organization's most-recent...

News published on 26 june 2021 at 10:00 and distributed by: