Indivior announces results from randomized, double-blind trial of SUBLOCADE

Indivior (INDV) announced results from a randomized, double-blind clinical trial published in JAMA Network Open. The study found that both the 100-mg and 300-mg monthly maintenance doses of SUBLOCADE rapidly reduced opioid use and improved opioid abstinence and were well tolerated, with no new safety signals in individuals with moderate-to-severe opioid use disorder. Participants across both dose groups experienced a rapid reduction in opioid use-from more than 43 instances per week at screening to fewer than three instances per week by week three-a decline maintained through week 38. Post-hoc analyses also identified a subset of individuals who may benefit from the higher 300-mg maintenance dose of extended-release buprenorphine. Participants who used fentanyl daily and/or 14 or more times per week had significantly higher opioid abstinence rates with 300-mg dose compared to 100 mg, suggesting a population that may potentially benefit from the higher maintenance dose regimen. Injection-site reactions were more common in the 300-mg arm but were mild to moderate and were not associated with discontinuation. Study limitations include the exploratory nature of the post-hoc analyses, which were not pre-specified in the trial’s statistical analysis plan.