You are here: Industry Insights > Braeburn

News List

Braeburn Submits Request for Final Approval of BRIXADI for Opioid Use Disorder americanpharmaceuticalreview
June 11, 2020
Braeburn 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 injection for the treatment of opioid use disorder (OUD).
Braeburn and Camurus’ Phase III opioid use disorder trial a success europeanpharmaceuticalreview
May 07, 2019
Braeburn Pharmaceuticals and Camurus announced positive results from Phase 3 trial supporting the safety and efficacy of CAM2038 in opioid use disorder…
Braeburn Announces Tentative FDA Approval of BRIXADI americanpharmaceuticalreview
December 27, 2018
Braeburn announced the U.S. Food and Drug Administration (FDA) has granted tentative approval of BRIXADI (buprenorphine) extended-release weekly (8mg, 16mg, 24mg, 32mg) and ......
Braeburn Announces Positive Top-line Phase 3 Results for CAM2038 americanpharmaceuticalreview
September 20, 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 therapy. CAM2038 is an investigational buprenorphine weekly a
Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder drugs
June 12, 2018
Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly depot injection for the treatment of opioid use disorder (OUD).