Braeburn's Brixadi (buprenorphine) Receives the US FDA’s Approval for Moderate to Severe Opioid Use Disorder
Shots:
- The US FDA has approved Brixadi extended-release inj. for SC use (CIII) to treat mod. to sev. opioid use disorder. Brixadi is available in 2 formulations: a weekly inj. for patients who have just started treatment & a monthly version who are already being treated with a transmucosal buprenorphine-containing product. The product is expected to be available in the US in Sept 2023
- The approval was based on a P-III trial evaluating Brixadi vs sublingual buprenorphine/naloxone in 428 patients which showed that Brixadi met the 1EPs of noninferiority for responder rate (16.9% vs 14.0%) & also met 2EPs of superiority in the percentage of negative opioid assessments from 4-24wk.
- Brixadi will be available through a restricted distribution program via the BRIXADI REMS program & is administered by a healthcare professional
Ref: PRNewswire | Image: Braeburn
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
