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Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

The Lancet Feb 24, 2019

Haight BR, et al. - As the administration of RBP-6000, referred to as BUP-XR (extended-release buprenorphine), mitigates abuse, misuse, diversion, and unintentional exposure in a health-care setting, researchers examined the efficacy of different BUP-XR dosing regimens in participants with opioid use disorder. In this randomized, double-blind, placebo-controlled, phase 3 trial that was performed at 36 treatment centers in the USA, screening was done in 1,187 potential participants. Of these participants, 665 entered run-in and 504 received BUP-XR 300 mg/300 mg (n=201), BUP-XR 300 mg/100 mg (n=203), or placebo (n=100). Compared with the placebo group, both BUP-XR groups displayed significantly higher participants' percentage abstinence. Furthermore, BUP-XR treatment was well tolerated among participants. For opioid use disorder, this monthly formulation represents an advance in treatment that intensifies the benefits of buprenorphine by delivering sustained, optimal exposure, while diminishing risks of current buprenorphine products.

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