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Brixadi Approval Status

FDA Approved: No
Brand name: Brixadi
Generic name: buprenorphine
Dosage form: Extended-Release Injection
Company: Braeburn Inc.
Treatment for: Opiate Dependence

Brixadi (buprenorphine) is a long-acting partial opioid agonist injection formulation in development for the treatment of opioid use disorder.

Development Status and FDA Approval Process for Brixadi

DateArticle
Dec 23, 2018Braeburn Announces Tentative FDA Approval of Brixadi (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder
Jul 16, 2018Camurus Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder
May 28, 2018Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder
Jan 21, 2018Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot
Nov  1, 2017Braeburn Announces FDA Advisory Committee Recommends Approval of CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder
Sep 18, 2017Camurus Announces that FDA Grants Priority Review of NDA for Weekly and Monthly CAM2038 Buprenorphine Depots for Treatment of Opioid Use Disorder
Jul 20, 2017Camurus and Braeburn Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use Disorder

Further information

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