Brixadi® (buprenorphine) extended-release subcutaneous injection is now available for the treatment of 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 buprenorphine. Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Brixadi contains buprenorphine, a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. The approval was based on data from a phase 3 trial ( Identifier: NCT02651584) that compared the long-acting subcutaneous treatment to an existing standard of care, sublingual buprenorphine/naloxone, in patients with moderate to severe OUD. 

Brixadi is available in either a weekly or monthly formulation for subcutaneous injection into the buttock, thigh, abdomen, or upper arm. The weekly injection can be administered to patients who have tolerated a single 4mg dose of a transmucosal buprenorphine‐containing product or those who are currently being treated with a transmucosal buprenorphine-containing product; injection sites should be alternated/rotated between injections. The monthly injection is appropriate for patients who are currently being treated with a transmucosal buprenorphine-containing product. 

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The most common adverse reactions reported with Brixadi were injection site reactions (eg, pain, erythema, pruritus), headache, constipation, nausea, insomnia, and urinary tract infection. Brixadi carries a Boxed Warning associated with a risk for serious harm or death if the product is administered intravenously. Because of this risk, Brixadi is only available through a Risk Evaluation and Mitigation Strategy (REMS) program; treatment should be administered only in a health care setting by a health care provider who is certified in the REMS program.

Brixadi, a Schedule III controlled substance, is supplied as prefilled single-dose syringes in weekly (8mg/0.16mL, 16mg/0.32mL, 24mg/0.48mL, 32mg/0.64mL) and monthly (64mg/0.18mL, 96mg/0.27mL, 128mg/0.36mL) doses. Doses of Brixadi (weekly) cannot be combined to yield an equivalent Brixadi (monthly) dose. The product does not require refrigeration.

“Brixadi is designed to align with how health care providers treat patients with OUD by offering multiple weekly and monthly dosing options to meet the patient where they are in their treatment journey,” said Paul Johnson, Chief Commercial Officer at Braeburn. “Health care providers and their patients with OUD will now have another FDA-approved option for long-acting, extended-release buprenorphine to address some of the challenges associated with the disease.”

This article originally appeared on MPR