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Indivior Says Data Published In 'JAMA Network Open' Shows SUBLOCADE 100mg And 300mg Improve Opioid Abstinence And Were Well-Tolerated With No New Safety Signals Identified

Benzinga·12/17/2025 16:35:57
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  • Both monthly maintenance doses (100 mg and 300 mg) improved opioid abstinence and were well-tolerated with no new safety signals identified.
  • Post-hoc analyses indicated the 300-mg monthly maintenance dose performed significantly better than the 100-mg monthly dose in participants reporting high-frequency fentanyl use.

RICHMOND, Va., Dec. 17, 2025 /PRNewswire/ -- Indivior PLC (NASDAQ:INDV) today 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® (extended-release buprenorphine) 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 (OUD). 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.