New Study Shows Extended-Release Buprenorphine Safely Delivers Rapid, Clinically Meaningful Reductions in Opioid Use and Supports Abstinence in High-Risk Populations
December 17, 2025 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – Indivior, clinical trials, opioid use disorder
- 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.
17 December 2025 — Virginia, US — Indivior PLC 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.
“These findings offer evidence to consider for clinicians navigating the complexities of OUD in the fentanyl era,” said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. “By demonstrating that extended-release buprenorphine improves abstinence, even among those with high-frequency fentanyl use, we underscore the need for treatment approaches that adapt to the realities of today’s opioid crisis and give patients the best chance at recovery.”
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.
About Indivior
Indivior Pharmaceuticals works to help change patients’ lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a human crisis to a recognized and treated chronic disease. Building on its portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Visit www.indivior.com to learn more.
