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General Information
Brixadi is an extended release formulation of buprenorphine, a partial opioid agonist.
Brixadi is specifically indicated for the treatment of moderate to severe opioid use
disorder in patients who have initiated treatment with a single dose of a
transmucosal buprenorphine product or who are already being treated with
buprenorphine.
Brixadi is supplied as a subcutaneous injection. It is supplied as a weekly or monthly medication and these are different formulations. Doses of Brixadi weekly cannot be combined to yield an equivalent Brixadi monthly) dose. Brixadi should be injected slowly, into the subcutaneous tissue of the buttock, thigh, abdomen, or upper arm. Strongly consider prescribing naloxone at the time Brixadi is initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. Injection sites for Brixadi (weekly) should be alternated/rotated for each injection.
Mechanism of Action
Brixadi contains buprenorphine, a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor.
Side Effects
Adverse effects associated with the use of Brixadi may include, but are not limited to, the following:
- injection site pain
- headache
- constipation
- nausea
- injection site erythema
- injection site pruritus
- insomnia
- urinary tract infection
The drug label comes with the following Black Box Warning: Serious harm or death could result if administered intravenously. Brixadi is only available through a restricted program called the Brixadi REMS. Healthcare settings and pharmacies that order and dispense Brixadi must be certified in this program and comply with the REMS requirements.
Clinical Trial Results
The FDA approval of Brixadi was based on an extensive clinical program with a randomized, active-controlled Phase 3 trial of Brixadi
against standard treatment with daily sublingual buprenorphine/naloxone (SL BPN). The pivotal trial met the primary endpoint of non-inferiority for responder rate (p<0.001) and the first secondary endpoint of superiority for the reduction of overall illicit use from week 4 through week 24 (p=0.004), measured by the cumulative distribution function of the percentage of negative opioid assessments. In addition, the product demonstrated rapid and prolonged reduction of withdrawal and cravings, and blockade of opioid drug liking.