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Background: RBP-6000 is a subcutaneously injected, extendedrelease, monthly treatment for opioid use disorder (OUD). RBP 6000 addresses potential limitations of other OUD treatments by delivering sustained buprenorphine plasma concentrations to block drug-liking of abused opioids over the entire monthly dosing period while controlling withdrawal and craving symptoms. Depot administration exclusively in a healthcare setting mitigates abuse, misuse, diversion, and unintentional paediatric exposure. Method: Treatment-seeking adults in the US with moderate or severe OUD entered a ≤2-week open-label phase with buprenorphine/naloxone sublingual film. Eligible participants were randomised to RBP 6000 300/300 mg (6×300 mg), RBP 6000 300/100 mg (2×300 mg 4×100 mg) or placebo for 24 weeks and received weekly counselling. No supplemental buprenorphine was allowed. The primary efficacy endpoint was percentage abstinence from opioid use based on negative urine samples and self-reports (Weeks 5-24). The key secondary efficacy endpoint was treatment success (participants with ≥80% abstinence from Weeks 5-24). Secondary efficacy endpoints included opioid craving and withdrawal signs/symptoms. Finding: From January to November 2015, 1187 participants were screened, 665 entered run-in, and 201, 203, and 100 were randomised to RBP 6000 300/300 mg, RBP 6000 300/100 mg, or placebo. Mean (SD) percentage abstinence was 41·3% (39·7%) and 42·7% (38·5%) for RBP 6000 300/300 mg and 300/100 mg compared with 5·0% (17·0%) placebo; treatment success was achieved for 57/196 (29·1%), 55/194 (28·4%), and 2/99 (2·0%) participants, (p |
