Braeburn Reports the US Commercial Availability of Brixadi (buprenorphine) Extended-Release Injection for Moderate to Severe Opioid Use Disorder
Shots:
- The company launches Brixadi extended-release inj. for SC use (CIII), a weekly & monthly medication for OUD who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a daily buprenorphine product
- The US FDA approval was based on the P-III efficacy and safety trial & an opioid blockade study of Brixadi. In the P-III study, Brixadi met the 1EPs of non-inferiority for responder rate vs SL BPN/NX (16.9% vs 14.0%), superiority to SL BPN/NX based on CDF of the percentage of negative opioid assessments from 4wk. through 24wk.
- In the opioid blockade study, complete blockade of the subjective effects of an opioid was sustained throughout the dosing intervals. Brixadi is available for healthcare settings & pharmacies through a restricted distribution program called BRIXADI REMS
Ref: PRNewswire | Image: Braeburn
Related News:- Braeburn's Brixadi (buprenorphine) Receives the US FDA’s Approval for Moderate to Severe Opioid Use Disorder
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