450 Plymouth Rd, Suite 400
Braeburn is a biopharmaceutical company dedicated to delivering solutions for people living with the serious, often fatal consequences of opioid use disorder. We are dedicated to advancing a portfolio of next-generation therapies, with individualized dosing regimens and delivery options, to address the escalating disease burden of addiction faced by patients, healthcare professionals, payers and society.
Braeburn has one mission: to fight the opioid addiction epidemic. The work we are doing can make a difference in the lives of patients who often shoulder the burden of treatment themselves. We aim to reduce stigma by raising awareness that OUD is a chronic brain disease best treated by evidence-based medication-assisted treatment.
We are dedicated to developing into a highly effective organization; and through collaboration and commitment we can execute on our mission. Our operating principles define how we work together to achieve our goals:
· Communicate directly, in an open and honest manner
· Honor our commitments
· Ask challenging questions
· Assume positive intent
· Listen and understand
· Support and invest in each other's development
For more information about Braeburn, please visit www.braeburnrx.com.
68 articles with Braeburn
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
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.
Braeburn Initiates Court Proceedings to Overturn Exclusivity and Seeks Immediate Market Approval of Brixadi™ in the US
The court action is based on thorough legal and regulatory assessments and is made with a view of achieving final market approval of Brixadi™ weekly and monthly depot before 30 November 2020.
Positive Treatment Results for BRIXADI™ (buprenorphine) Extended-Release Injection in Fentanyl Positive Patients Presented at the 50th Conference of the American Society of Addiction Medicine
Phase 3 post-hoc analyses indicate less fentanyl and overall illicit opioid use for weekly/monthly buprenorphine depots versus daily standard treatment
Braeburn Announces Tentative FDA Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder
BRIXADI™ is a long-acting buprenorphine injectable with both weekly and monthly doses to align with the way healthcare providers treat patients with OUD
Braeburn Announces Positive Top-line Phase 3 Results for CAM2038 in Chronic Low Back Pain Patients Previously on Long-term Daily Opioid Therapy
CAM2038 is an investigational buprenorphine weekly and monthly subcutaneous depot injection for healthcare professional (HCP) administration.
If approved, CAM2038 will provide patients and HCPs with flexible-dose weekly and monthly options for the treatment of opioid use disorder, with the goal of improving treatment adherence and reducing the burdens associated with daily medication.
Dr. Malamut brings to Braeburn more than 25 years of pharmaceutical and clinical leadership experience at emerging and leading biopharmaceutical companies.
Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038.
Braeburn Announces Publication of Positive Phase 3 Results For Long-Acting Buprenorphine For Treatment Of Opioid Use Disorder in JAMA Internal Medicine
Braeburn announced today that the results from its Phase 3 study to evaluate the efficacy and safety of CAM2038
TissueTech Inc., pioneers of the development and clinical application of amniotic tissue-based products, announced today the appointment of Dr. Frank Young as Executive Vice President of Regulatory Affairs.
Braeburn's receipt of a CRL from the FDA regarding the NDA for its injectable buprenorphine product is likely to negatively impact Braeburn's Probuphine marketing activities as it focuses on addressing the CRL.
Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot for the Treatment of Opioid Use Disorder
The FDA has requested additional information in order to progress the application forward.
1/11/2018Proceeds to finance investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder.
12/21/2017Although it was an average year for mergers and acquisitions in the biopharma industry, it was a stronger year for IPOs.
Braeburn Announces FDA Advisory Committee Recommends Approval of CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder
Braeburn today announced that the U.S. FDA Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 recommending approval of CAM2038, .
Braeburn Pharma Announces FDA Acceptance With Priority Review Of New Drug Application For CAM2038 Buprenorphine Depot For The Treatment Of Opioid Use Disorder
Braeburn Pharma And Camurus Announce Submission Of NDA For Long-Acting Buprenorphine (CAM2038) For Opioid Use Disorder
Camurus And Braeburn Pharma Announce Topline Phase II Results For Long-Acting Buprenorphine In Opioid Dependent Patients With Chronic Pain
Braeburn Pharma Release: Phase II Trial Demonstrates Long-acting Buprenorphine Blocks Opioid Effects and Suppresses Withdrawal Symptoms in Adults with Opioid Use Disorder