| Date | Title | Description |
| 30.09.2024 | Braeburn Debuts Inspiring Docuseries Celebrating Advocates Uplifting Communities to Combat the Opioid Crisis | “Reframe and Reclaim: Shaping the Future of Recovery Stories” follows eight Philadelphia-based advocates in their efforts to educate and increase community awareness of this public health crisis
The three-part series is now available on the... |
| 25.06.2024 | Braeburn Announces Publication of a Post Hoc Analysis of Data from Patients Using Fentanyl Treated with BRIXADI in a Phase 3 Efficacy and Safety Study | PLYMOUTH MEETING, Pa., June 25, 2024 /PRNewswire/ -- Braeburn Inc. announces the publication of a post hoc analysis in the Journal of the American Medical Association (JAMA) Network Open. The analysis evaluated data in patients with evidenc... |
| 05.09.2023 | BRIXADI® (buprenorphine) Extended-Release Injection for Subcutaneous Use (CIII) is Now Available in the U.S. for the Treatment of Moderate to Severe Opioid Use Disorder | BRIXADI is now available for healthcare settings and pharmacies through a restricted distribution program called the BRIXADI REMS and is administered only by a healthcare professional.
PLYMOUTH MEETING, Pa., Sept. 5, 2023 /PRNewswire/ -- B... |
| 05.09.2023 | BRIXADI® (buprenorphine) Extended-Release Injection for Subcutaneous Use (CIII) is Now Available in the U.S. for the Treatment of Moderate to Severe Opioid Use Disorder | BRIXADI is now available for healthcare settings and pharmacies through a restricted distribution program called the BRIXADI REMS and is administered only by a healthcare professional. |
| 23.05.2023 | Braeburn's BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder | BRIXADI is the first and only long-acting buprenorphine injectable with both weekly and monthly doses.
Patients currently on a transmucosal buprenorphine-containing product can be switched to an equivalent dose of BRIXADI Weekly or Monthly... |
| 23.05.2023 | Braeburn's BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder | BRIXADI is the first and only long-acting buprenorphine injectable with both weekly and monthly doses. |
| 23.12.2022 | Braeburn Applauds Passage of Significant Advancements in the Treatment of Opioid Use Disorder | Plymouth Meeting, Pa.—December 23, 2022—The recently passed Senate Amendment to H.R. 2617 – Consolidated Appropriations Act, 2023 – includes significant advances in the treatment of opioid use disorder by expanding access to treatment and e... |
| 23.12.2022 | Braeburn Applauds Passage of Significant Advancements in the Treatment of Opioid Use Disorder | Plymouth Meeting, Pa.—December 23, 2022—The recently passed Senate Amendment to H.R. 2617 – Consolidated Appropriations Act, 2023 – includes significant advances in the treatment of opioid use disorder by expanding access to treatment and e... |
| 08.12.2022 | FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder | Prescription Drug User Fee Act (PDUFA) action date set for May 23, 2023.
Plymouth Meeting, Pa. – December 8, 2022 – Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly inje... |
| 08.12.2022 | FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder | Prescription Drug User Fee Act (PDUFA) action date set for May 23, 2023. |
| 26.06.2021 | FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder | Prescription Drug User Fee Act (PDUFA) action date set for December 15, 2021 |
| 26.06.2021 | FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder | Prescription Drug User Fee Act (PDUFA) action date set for December 15, 2021
Plymouth Meeting, Pa. – June 26, 2021 – Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly inj... |
| 26.06.2021 | FDA Accepts Braeburn's New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder | |
| 15.06.2021 | Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder | Plymouth Meeting, Pa. – June 15, 2021 – Braeburn announces that today the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was resu... |
| 15.06.2021 | Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder | |
| 15.06.2021 | Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder | Plymouth Meeting, Pa. – June 15, 2021 – Braeburn announces that today the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was resu... |
| 15.06.2021 | Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder | Plymouth Meeting, Pa. – June 15, 2021 – Braeburn announces that today the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was resu... |
| 10.12.2020 | Braeburn Announces Arbitration Determination that It Did Not Materially Breach Its License Agreement with Camurus AB | |
| 01.06.2020 | Braeburn Submits Request for Final Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder | Plymouth Meeting, Pa. — June 1, 2020 — Braeburn announces that it has requested final approval from the U.S. Food and Drug Administration (FDA) of the New Drug Application for BRIXADI™ (buprenorphine) weekly and monthly extended-release inj... |
| 01.06.2020 | Braeburn Submits Request for Final Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder | Plymouth Meeting, Pa. — June 1, 2020 — Braeburn announces that it has requested final approval from the U.S. Food and Drug Administration (FDA) of the New Drug Application for BRIXADI™ (buprenorphine) weekly and monthly extended-release inj... |
| 23.07.2019 | 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 | PLYMOUTH MEETING, Pa., July 23, 2019 -- (PRNewswire) -- The U.S. District Court for the District of Columbia (District Court) granted Braeburn's motion for summary judgment, vacating the U.S. Food and Drug Administration's (FDA) December 20... |
| 23.07.2019 | 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 | PLYMOUTH MEETING, Pa., July 23, 2019 -- (PRNewswire) -- The U.S. District Court for the District of Columbia (District Court) granted Braeburn's motion for summary judgment, vacating the U.S. Food and Drug Administration's (FDA) December 20... |
| 04.06.2019 | 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 us... |
| 04.06.2019 | 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 us... |
| 11.04.2019 | Braeburn petitions FDA to revoke Sublocade orphan designation | A citizen petition filed last week by law firm Goodwin Procter on behalf of Pennsylvania-based drugmaker Braeburn calls on the FDA to revoke the orphan designation granted to Indivior’s opioid use disorder treatmen... |
| 23.12.2018 | 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
Plymouth Meeting, Pa. — December 23, 2018 — Braeburn today announced that the U.S. Foo... |
| 23.12.2018 | 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 |
| 21.09.2018 | CAM2038 Receives Positive CHMP Opinion for the Treatment of Opioid Dependence in Europe | Plymouth Meeting, PA—September 21, 2018 — Braeburn announces that Camurus has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of CAM2038,... |
| 21.09.2018 | CAM2038 Receives Positive CHMP Opinion for the Treatment of Opioid Dependence in Europe | Plymouth Meeting, PA—September 21, 2018 — Braeburn announces that Camurus has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of CAM2038,... |
| 18.09.2018 | Braeburn Announces Positive Top-line Phase 3 Results for CAM2038 in Chronic Low Back Pain Patients Previously on Long-term Daily Opioid Therapy | Plymouth Meeting, PA—September 18, 2018 — Braeburn announces positive top-line results for a Phase 3 study of CAM2038 for the treatment of moderate-to-severe Chronic Low Back Pain (CLBP) in patients previously on long-term daily opioid ther... |
| 18.09.2018 | Braeburn Announces Positive Top-line Phase 3 Results for CAM2038 in Chronic Low Back Pain Patients Previously on Long-term Daily Opioid Therapy | Plymouth Meeting, PA—September 18, 2018 — Braeburn announces positive top-line results for a Phase 3 study of CAM2038 for the treatment of moderate-to-severe Chronic Low Back Pain (CLBP) in patients previously on long-term daily opioid ther... |
| 29.06.2018 | Andrew Ritter gathers the reins as his company preps PhIII; Solid Bio co-founder Gilad Hayeem retires | Andrew Ritter
→ The series of executive hiring at Ritter Pharmaceuticals $RTTR has culminated in co-founder Andrew Ritter’s appointment as CEO. Michael Step is stepping down after four years at the helm, but will cont... |
| 10.01.2018 | Braeburn Announces Completion of $110 Million Financing | Princeton, N.J.— January 10, 2018 — Braeburn Pharmaceuticals, Inc. (Braeburn) today announced that the Company has completed a $110 million mezzanine round of financing led by Wellington Capital Management. Other new investors participating... |
| - | FDA Grants Braeburn’s Citizen Petition Allowing BRIXADI (buprenorphine) Extended-Release Injection for Opioid Use Disorder to be Available in December 2020 | 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
Plymouth Meeting, Pa. – November 7, 2019 – Braeburn Inc. is pleas... |
| - | Braeburn Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder | 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 medica... |
