Braeburn
450 Plymouth Rd, Suite 400
Plymouth Meeting
PA
19462
United States
Tel: 610-467-8680
Website: http://www.braeburnrx.com/
Email: info@braeburnrx.com
About Braeburn
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.
75 articles about Braeburn
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Altruix Approved to Dispense Brixadi® for Moderate to Severe Opioid Use Disorder
8/17/2023
Altruix announced today that it has been selected as a limited distribution partner by Braeburn Inc. for BRIXADI (buprenorphine) extended-release subcutaneous injection (CIII).
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The FDA approved Braeburn Pharmaceuticals’ new buprenorphine treatment option with extended-release medication that could pave the way for greater patient compliance.
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FDA Accepts Braeburn's New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
6/26/2021
Braeburn announces that the New Drug Application for BRIXADI extended-release weekly and monthly injection for subcutaneous use for moderate to severe opioid use disorder was accepted by the U.S. Food and Drug Administration.
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Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
6/15/2021
Braeburn announces that today the New Drug Application (NDA) for BRIXADI was resubmitted to the U.S. Food and Drug Administration (FDA).
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FDA Grants Braeburn's Citizen Petition Allowing BRIXADI (buprenorphine) Extended-Release Injection for Opioid Use Disorder to be Available in December 2020
11/8/2019
FDA revokes Indivior PLC's orphan designation for opioid use disorder (OUD)* and prevents an additional five-year block of other monthly buprenorphine depot products for OUD
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Braeburn has been fighting the FDA over its award of Orphan Drug Designation to another opioid use disorder treatment that will prevent competition through November 2020. More than 2 million people in the U.S. have been diagnosed with the disease.
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U.S. District Court Orders FDA to Reconsider Application for Final Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder
7/23/2019
Braeburn's application for final approval of BRIXADI is remanded back to FDA for reconsideration "with deliberate speed."
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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
6/4/2019
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.
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Braeburn Initiates Court Proceedings to Overturn Exclusivity and Seeks Immediate Market Approval of Brixadi™ in the US
4/9/2019
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.
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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
4/6/2019
Phase 3 post-hoc analyses indicate less fentanyl and overall illicit opioid use for weekly/monthly buprenorphine depots versus daily standard treatment
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Braeburn Announces Tentative FDA Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder
12/23/2018
BRIXADI™ is a long-acting buprenorphine injectable with both weekly and monthly doses to align with the way healthcare providers treat patients with OUD
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Braeburn Announces Positive Top-line Phase 3 Results for CAM2038 in Chronic Low Back Pain Patients Previously on Long-term Daily Opioid Therapy
9/18/2018
CAM2038 is an investigational buprenorphine weekly and monthly subcutaneous depot injection for healthcare professional (HCP) administration.
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Braeburn Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder
7/16/2018
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.
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Braeburn Appoints Richard Malamut, M.D. as Chief Medical Officer
6/25/2018
Dr. Malamut brings to Braeburn more than 25 years of pharmaceutical and clinical leadership experience at emerging and leading biopharmaceutical companies.
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Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder
6/12/2018
Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038.
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Braeburn Announces Publication of Positive Phase 3 Results For Long-Acting Buprenorphine For Treatment Of Opioid Use Disorder in JAMA Internal Medicine
5/14/2018
Braeburn announced today that the results from its Phase 3 study to evaluate the efficacy and safety of CAM2038
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TissueTech Appoints Dr. Frank Young Executive Vice President of Regulatory Affairs
5/10/2018
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.
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Titan in Discussions With Braeburn Regarding U.S. Probuphine Commercialization
1/22/2018
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.
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Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot for the Treatment of Opioid Use Disorder
1/22/2018
The FDA has requested additional information in order to progress the application forward.
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New Jersey's Braeburn Pharma Lands $110M
1/11/2018
Proceeds to finance investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder.