FDA Approves Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
Braeburn Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (CIII), a new weekly and monthly medication for moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a transmucosal buprenorphine-containing product.
Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support. Brixadi is to be administered only by healthcare providers in a healthcare setting and will be available in the U.S. in September 2023.
Brixadi is the first and only weekly and monthly subcutaneous injection for moderate to severe OUD and is the only buprenorphine injectable that utilizes FluidCrystal®* Injection Depot Technology. Patients currently being treated with oral buprenorphine-containing products can be switched to equivalent doses of Brixadi Weekly or Brixadi Monthly in accordance with the Prescribing Information for Brixadi.
