Thought leadership on the clinical impact on workers' compensation and auto no-fault.
FDA approves new buprenorphine treatment option
On May 23, 2023, the U.S. Food and Drug Administration (FDA) approved Brixadi™ (buprenorphine) extended-release injection for the treatment of moderate to severe opioid use disorder (OUD) in patients who have started treatment with a single dose of transmucosal buprenorphine or are already being treated with buprenorphine.
Brixadi is approved for both weekly and monthly subcutaneous (under the skin) injections and will be available in various doses. The approved weekly formulation, in lower strengths, offers a new option for people in recovery who may benefit from a weekly injection to maintain treatment adherence.
Braeburn Inc., received FDA approval for Brixadi injections and stated in a press release that additional medication options for OUD will support healthcare providers in addressing the needs of their patients with this disorder. Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Brixadi is expected to become available in the U.S. in the fall of 2023 and will be part of the Risk Evaluation and Mitigation Strategy (REMS) program. For more information on the Brixadi REMS program, click here.
Impact on workers’ compensation and auto no-fault
We anticipate that Brixadi will have minimal impact to our book of business after market launch due to the following:
- It should never be dispensed directly to a patient.
- It must be administered by a healthcare provider in a healthcare setting.
- It will only be available through a restricted distribution program called the Brixadi REMS program due to the risk of serious harm that could result from accidental intravenous administration.
If you have any questions, please contact your account manager, clinical liaison, or our Clinical Services team at 1-877-275-7674 ext. 8612.
- Brixadi website - BRIXADI™ (buprenorphine) injection for subcutaneous use is now approved! Accessed June 21, 2023.
- FDA Press Release – FDA Approves New Buprenorphine Treatment Option for Opioid Use Disorder | FDA . Accessed on June 21, 2023.
- PR Newswire Press Release - Braeburn's BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder (prnewswire.com). Accessed on June 21, 2023.