— 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.
Indivior PLC (Nasdaq: INDV) today announced resultsfromarandomized,double-blindclinicaltrialpublishedinJAMANetwork Open.The study found that both the 100-mg and 300-mg monthly maintenance doses ofSUBLOCADE® (extended-releasebuprenorphine) rapidlyreduced opioid use and improved opioid abstinence and were well tolerated, with no new safety signals in individuals withmoderate-to-severe opioid use disorder (OUD). Participants across both dose groups experiencedarapidreduction inopioid 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.
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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-sitereactions weremorecommoninthe300-mgarmbutweremildtomoderate 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 analysisplan.
AboutSUBLOCADE®
SUBLOCADE®(buprenorphineextended-release)injection,forsubcutaneoususe, CIII
INDICATIONANDHIGHLIGHTEDSAFETY INFORMATION INDICATION
SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.
SUBLOCADEshould beusedaspartofacomplete treatmentplanthatincludescounseling and psychosocial support.
HIGHLIGHTEDSAFETYINFORMATION
WARNING:RISKOFSERIOUSHARMORDEATHWITHINTRAVENOUS
ADMINISTRATION;SUBLOCADERISKEVALUATIONANDMITIGATIONSTRATEGY
— Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously.
— Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program call the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements.
CONTRAINDICATIONS
HypersensitivitytobuprenorphineoranyotheringredientsinSUBLOCADE.
WARNINGSANDPRECAUTIONS
Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can beabusedin a manner similar toother opioids. Monitor patientsforconditionsindicativeofdiversionorprogressionofopioiddependenceand addictivebehaviors.
RespiratoryDepression:Lifethreateningrespiratorydepressionanddeath haveoccurredin association with buprenorphine. Warn patients of the potential danger of self-administrationofbenzodiazepinesorotherCNSdepressantswhileundertreatment with SUBLOCADE.
RiskofSerious InjectionSite Reactions: Likelihood of may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema and pruritus with some involving abscess, ulceration and necrosis.
NeonatalOpioid WithdrawalSyndrome:Neonatal opioidwithdrawalsyndrome (NOWS)is an expected and treatable outcome of prolonged use of opioids during pregnancy.
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately.
RiskofHepatitis,Hepatic Events:Monitorliverfunctiontestspriortoandduring treatment.
RiskofWithdrawalinPatientsDependent onFullAgonistOpioids:Verifythatpatients have tolerated transmucosal buprenorphine before injecting SUBLOCADE.
TreatmentofEmergent AcutePain:Treat painwithanon-opioid analgesic wheneverpossible.Ifopioidtherapy isrequired,monitor patientscloselybecause higherdosesmay be required for analgesic effect.
ADVERSEREACTIONS
Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepaticenzymes,fatigue,andinjection sitepain.
For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visitwww.sublocade.com.
AboutOpioidUseDisorder(OUD)Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences. OUD may affect the parts of the brain thatarenecessaryforlife-sustainingfunctions.
About IndiviorIndivior 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. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.
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SOURCE Indivior PLC
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