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Buprenorphine ER plain language summary with DOI 6 Mar.pdf (222.94 kB)

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

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posted on 2024-03-05, 22:20 authored by Hannah A. Blair

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.


Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.


Additional information about this Adis Drug Review can be found here


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.


© Springer Nature Switzerland AG 2024

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