Buprenorphine extended-release injection (Brixadi®) in the management of opioid use disorder: a profile of its use in the USA

Abstract

Buprenorphine extended-release (ER) injection for subcutaneous use (Brixadi®; CAM2038; hereafter referred to as buprenorphine ER) is a useful addition to the treatment options for opioid use disorder (OUD). Brixadi® is formulated using FluidCrystal® injection depot technology, allowing for a low volume prefilled syringe and steady release of buprenorphine over one week or one month. In a pivotal phase 3 trial, weekly or monthly subcutaneous buprenorphine ER was non-inferior to daily sublingual buprenorphine/naloxone in terms of the proportion of opioid-negative urine samples and the responder rate. Based on the cumulative distribution function of the percentage of opioid-negative samples, superiority was demonstrated with subcutaneous buprenorphine ER compared with sublingual buprenorphine/naloxone. In the DEBUT trial, patients who received subcutaneous buprenorphine ER reported higher and more sustained treatment satisfaction than those who received sublingual buprenorphine. Real-world studies have also demonstrated high levels of satisfaction with buprenorphine ER in patients with opioid dependence. Buprenorphine ER was generally well tolerated, with a systemic safety profile similar to that of sublingual buprenorphine/naloxone. The most common treatment-emergent adverse events were injection-site reactions.