Compared to patients adherent to monthly injectable buprenorphine, patients on other MOUD (adherent and non-adherent) were 3.5 to 8.1x more likely to return to opioid use.
In a separate study, patients receiving monthly injectable buprenorphine had a 62% lower incidence of bacteremia and fewer inpatient, emergency, and outpatient visits than those receiving daily oral buprenorphine

RICHMOND, Va., May 20, 2026 (GLOBE NEWSWIRE) -- Indivior Pharmaceuticals, Inc., (NASDAQ:INDV) today announced findings from two new real-world evidence studies showing that adherence to extended-release buprenorphine, a monthly injectable commercially available as SUBLOCADE^®, is associated with lower relapse risk, fewer infection-related complications, and reduced healthcare utilization among people living with opioid use disorder (OUD).

"Collectively, these studies highlight the benefits of sustained treatment with monthly injectable buprenorphine, including reduced relapse risk and fewer serious complications that often drive acute care use," said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. "These findings also emphasize the importance of proactively identifying patients at risk of treatment discontinuation and supporting continued access to evidence‑based medications for opioid use disorder."

One retrospective claims analysis, published in Drug and Alcohol Dependence Reports, analyzed 3,400 patients' 12‑month adherence rates to monthly injectable buprenorphine and its association with return to opioid use.

Patients adherent to extended-release buprenorphine were 3.5 to 8.1 times less likely to return to opioid use compared to other groups who were non-adherent, or adherent to other forms of MOUD.
Additional relapse risk factors included younger age, male sex, Medicaid coverage, urban residence, comorbid alcohol or other substance use disorders, skin infections, and limited prior engagement with buprenorphine treatment before initiation of the extended-release injection.

A second retrospective cohort study, published in The Journal of Substance Use and Addiction Treatment, compared infectious disease outcomes and healthcare utilization between 467 patients receiving monthly injectable buprenorphine and nearly 120,000 patients on daily oral buprenorphine.

Patients adherent to extended-release buprenorphine had a 62% reduction in bacteremia incidence (bloodstream infections) compared to those adherent to oral buprenorphine.
Furthermore, patients in the extended-release buprenorphine group had lower overall healthcare utilization during the 6-month follow-up. This included 56% fewer inpatient visits, 22% fewer ED visits, 21% fewer all-cause outpatient visits, and 77% fewer sexually transmitted infections-related outpatient visits.

"These data highlight the importance of how treatment delivery impacts outcomes for those living with opioid use disorder," said Ann Wheeler, PharmD, Vice President, Medical Affairs at Indivior. "By improving continuity of care, monthly injectable buprenorphine treatment has the potential to reduce costly acute care crises across the healthcare system and support meaningful, long-term recovery."

As both studies were retrospective real-world evidence analyses using existing claims and electronic health record data, these findings should be viewed in the context of the study designs and data-source possibilities.

Findings from the relapse analysis, published in Drug and Alcohol Dependence Reports, are available here: Relationship Between Extended-Release Buprenorphine Adherence and Reduced Risk of Return to Use in Patients with Opioid Use Disorder: A Retrospective Claims Data Analysis

Relapse was identified using claims-based proxy measures, and some treatment or outcome events may not have been fully captured in administrative claims data, including during the COVID-19 pandemic.

The infectious disease and healthcare utilization analysis, published in The Journal of Substance Use and Addiction Treatment, is available here: Assessing Impact of Buprenorphine for Opioid Use Disorder on Infectious Disease Management

This analysis may not capture care received outside the data network. The size and duration of the extended-release cohort may limit precision for some comparisons.

Both studies were funded by Indivior and conducted in partnership with external academic and research collaborators using large U.S. claims and electronic health record–linked datasets.

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 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

As the leader in long-acting injectable treatments for opioid use disorder (OUD), Indivior is singularly focused on delivering evidence-based treatment and advancing understanding of OUD as a chronic but treatable brain disease. For more than 25 years, we have revolutionized the science of addiction medicine, developing treatments that help people move toward long-term recovery with independence and dignity. Building on this heritage, we are ushering in a new era, renewing our commitment to individuals living with OUD and carrying forward what matters most: compassion, integrity, and science. Together – with science, people living with OUD, public health champions, and communities – we are powering recovery and renewing hope. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.

For Further Information

Investors:

Jason Thompson

Indivior Pharmaceuticals

Tel: 804-402-7123

E-mail: jason.thompson@indivior.com

Media:

Cassie France-Kelly

Indivior Pharmaceuticals

Tel: 804-594-0836

E-mail: Indiviormediacontacts@indivior.com

New Studies Show Adherence to Monthly Injectable Buprenorphine is Associated with Relapse Reduction and Lower Healthcare Utilization