New Study Shows Extended-Release Buprenorphine Safely Delivers Rapid, Clinically Meaningful Reductions in Opioid Use and Supports Abstinence in High-Risk Populations

Core Findings - Indivior PLC announced positive results from a randomized, double-blind clinical trial of SUBLOCADE® (extended-release buprenorphine), showing rapid reduction in opioid use and improved abstinence rates in individuals with moderate-to-severe opioid use disorder (OUD) [1][7] - Both 100-mg and 300-mg monthly maintenance doses were well tolerated, with no new safety signals identified [1][7] Clinical Trial Results - Participants in both dose groups experienced a significant decrease in opioid use, from over 43 instances per week at screening to fewer than three instances per week by week three, a trend maintained through week 38 [1] - Post-hoc analyses indicated that individuals using fentanyl daily or 14 or more times per week had higher abstinence rates with the 300-mg dose compared to the 100-mg dose, suggesting a specific population that may benefit from the higher dose [2][7] Expert Commentary - Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior, emphasized the importance of adapting treatment approaches to the realities of the current opioid crisis, particularly for patients with high-frequency fentanyl use [3] Product Information - SUBLOCADE® is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine product or are already being treated with buprenorphine [4] - It should be part of a comprehensive treatment plan that includes counseling and psychosocial support [4] Safety Information - The administration of SUBLOCADE via intravenous route poses serious risks, including the potential for serious harm or death, leading to its availability only through a restricted program [8] - Common adverse reactions associated with SUBLOCADE include constipation, headache, nausea, and injection site pain, occurring in 5% of subjects [14]