Indivior Real World Evidence Study Finds Medications for Opioid Use Disorder, Particularly Extended-Release Buprenorphine, Reduced Odds of Emergency Department Visits for Patients with Opioid Use Disorder

• Extended-release buprenorphine (BUP-XR) had lower rates of hospitalizations, emergency department (ED) visits, and outpatient physician office visits compared to those receiving daily oral buprenorphine or no medications for opioid use disorder (MOUD)
• The study indicates BUP-XR may be an important tool in reducing ED visits, improving healthcare resource utilization and patient outcomes

RICHMOND, Va., July 23, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV) today announced results from a new retrospective real-world study published in Drug and Alcohol Dependence Reports, which examined demographic and clinical factors associated with ED visits among adults diagnosed with opioid use disorder (OUD) over a six-month follow-up period.

The study found that patients treated with BUP-XR, in the form of the once-monthly long-acting injectable formulation of buprenorphine, had 57% lower odds of all-cause ED visits compared to those who received no MOUD. Additionally, patients treated with BUP-XR experienced significantly fewer hospitalizations and lower inpatient costs compared to those receiving daily oral buprenorphine or no MOUD.

"Opioid overdose-related ED visits are a critical concern in the ongoing opioid epidemic," said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. "These findings underscore the clinical and economic value of long-acting injectable treatments of OUD. By reducing ED and physician office visits, BUP-XR may help ease the burden on our healthcare system while supporting long-term recovery outcomes for patients."

The Indivior-funded study also revealed that patients treated with BUP-XR incurred lower inpatient healthcare costs. Inpatient costs for this group were nearly five times lower compared to patients receiving daily oral buprenorphine, and more than 10 times lower compared to patients receiving no MOUD. The BUP-XR cohort did have similar overall all-cause costs compared to the no MOUD cohort and had significantly higher overall costs compared to the daily oral buprenorphine cohort; this was primarily driven by higher outpatient pharmacy costs in the BUP-XR cohort, although it was not possible to determine if the BUP-XR medication itself was driving the difference.

Hospitalization rates for BUP-XR were similarly lower: only 3% of BUP-XR-treated patients experienced an inpatient stay during the six-month follow-up period, versus 5% of those on daily oral buprenorphine. Notably, no opioid overdose-related ED visits were recorded among patients in the BUP-XR cohort during the study period; in the daily oral buprenorphine cohort there was a 1.2% overdose rate and 1% in the no MOUD cohort.

These findings are based on observed claims data and reflect healthcare utilization during the defined study period. Although the results offer valuable insights for public health officials, emergency care providers, and policymakers, the study sample may not fully represent all individuals with OUD, particularly those who are uninsured or outside traditional healthcare systems. Additionally, the six-month observation window may not capture long-term treatment engagement or relapse risk.

The full study is available here: Factors associated with emergency room visits among patients with opioid use disorder: A study of buprenorphine-treated and untreated patients - ScienceDirect

Disclosure:

This press release has been issued by Indivior Inc. and the content has not been approved or authorized by the College on Problems of Drug Dependence.

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 global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease.

Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

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