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SUBLOCADE for Opioid Use Disorder

Withdrawal and craving scores for the buprenorphine product remained constant and consistently lower than placebo.

A PPM Brief

Indivior (Richmond, VA) announced positive data on the efficacy of its buprenorphine extended-release product, SUBLOCADE, as a subcutaneous injection, in a Phase 3 study.1

A total of 504 adults with moderate or severe opioid use disorder (OUD) were randomized to receive monthly SUBLOCADE 300/300 mg and 300/100 mg dosage regimens or placebo for a total of 24 weeks; participants also underwent weekly drug counseling. The trial met primary and secondary endpoints, demonstrating significant differences in percentage abstinence from opioid use based on negative urine samples, self-reports, and treatment success defined as participants with a greater than or equal to 80% opioid abstinence compared to placebo. Retention was nearly twice as high with SUBLOCADE compared to placebo, with no compensatory non-opioid drug use observed during treatment. In addition, increased medication satisfaction was found among participants treated with SUBLOCADE compared to placebo.

“Findings show that SUBLOCADE … delivered sustained buprenorphine exposure for the entire monthly period while increasing abstinence rates and controlling craving and withdrawal symptoms for patients in this pivotal trial, compared to placebo. This represents an effective option in the treatment of opioid use disorder,” said Christian Heidbreder, PhD, chief scientific officer at Indivior, in a release.

Withdrawal and craving scores for the buprenorphine product remained constant and consistently lower than placebo. (Source: 123RF)

The safety profile of SUBLOCADE was consistent with other buprenorphine products for OUD treatment, except in the case of injection-site reactions, in which they were worse. These reactions were mostly mild and not treatment-limiting; the most common being headache, constipation, nausea, and pruritus at the injection site.

According to a company news release,2 the study is the first of its kind to translate prior observations suggesting that ≥70% to 80% brain mu-opioid receptor occupancy is associated with buprenorphine plasma concentrations of ≥ 2 to 3 ng/mL to block subjective drug-liking of exogenous opioids.

Last updated on: March 14, 2019
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