Clinical Evidence Supports Rapid SUBLOCADE® Induction as a Strategy to Improve Retention in Opioid Use Disorder Treatment

Richmond, VA, October 15, 2025  – Indivior PLC (Nasdaq: INDV) this week published compelling results from a multicenter, open-label clinical trial published in JAMA Network Open. Two approaches were evaluated for initiating treatment with SUBLOCADE®, extended-release buprenorphine, in individuals who met criteria for moderate-to-severe opioid use disorder (OUD) and who engage in high-risk opioid use—including injection use, high-dose consumption, or fentanyl use. 

The study found that rapid induction—administration of a single dose of 4-mg oral buprenorphine followed by a same-day SUBLOCADE injection—was well tolerated and led to higher retention at the second injection compared to standard induction, which is at least seven days of oral buprenorphine dose adjustments prior to the first injection of SUBLOCADE. These benefits were observed across the full study population and were especially pronounced among fentanyl-positive participants, addressing the clinically relevant outcome that patients remain engaged with treatment after induction. 

The trial also demonstrated that administering the second SUBLOCADE injection just one week after the first was well tolerated in both treatment arms as the safety profile up to injection two was comparable, reinforcing the potential for an agile and patient-centered treatment model with rapid induction. A similar proportion of participants in adverse events up to injection two. 

“This study represents a pivotal advancement for both patients and clinicians confronting opioid use disorder in the fentanyl era,” said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. “The demonstration that rapid, same-day induction onto SUBLOCADE is not only effective but also well tolerated is opening a critical window of opportunity to keep high-risk patients with moderate-to-severe OUD engaged in care during their most vulnerable early weeks of treatment.” 

Study limitations include its open-label design, which could introduce some reporting bias, although there was no evidence of patient and provider preference for either strategy.  

About SUBLOCADE® 

SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII 

INDICATION AND HIGHLIGHTED SAFETY 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. 

SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. 

HIGHLIGHTED SAFETY INFORMATION 

WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS 

ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY 

• 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 

Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE. 

WARNINGS AND PRECAUTIONS 

Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. 

Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE. 

Risk of Serious Injection Site 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. 

Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (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. 

Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment. 

Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patients have tolerated transmucosal buprenorphine before injecting SUBLOCADE. 

Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. 

ADVERSE REACTIONS 

Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain. 

For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit www.sublocade.com. 

About Opioid Use Disorder (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 that are necessary for life-sustaining functions. 

About Indivior

Indivior is a pharmaceutical company working 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.