Indivior Presents New Data at CPDD Demonstrating that High Buprenorphine Exposure May Improve Treatment Outcomes in High Fentanyl Users

Rhea-AI Summary

Indivior (NASDAQ: INDV) presented new data at CPDD showing that higher doses (300mg) of SUBLOCADE, their buprenorphine extended-release treatment, may improve outcomes for opioid use disorder (OUD) patients with heavy fentanyl use. While not statistically significant compared to 100mg doses, the 300mg maintenance dose showed clinically meaningful improvements in opioid abstinence. Both dosing regimens demonstrated significant reductions in opioid use, from 40 instances weekly to fewer than 3 by Week 3, sustained through Week 38, with no new safety concerns. The company also presented research on treatment barriers for American Indian/Alaska Native populations, who face disproportionate OUD rates. A claims analysis of 75,000+ AI/AN patients revealed that 73.1% used non-IHS providers, and MOUD-treated patients showed lower emergency department visits.

Positive

• Higher 300mg dose of SUBLOCADE showed potential improved outcomes for heavy fentanyl users
• Both 100mg and 300mg doses significantly reduced weekly opioid use from 40 to less than 3 instances
• No new safety concerns identified with either dosing regimen
• MOUD-treated patients showed lower emergency department visits

Negative

• 300mg dose did not show statistically significant advantage over 100mg for weekly abstinence
• AI/AN populations face significant barriers to accessing medication for opioid use disorder

Insights

Pharmaceutical Research Analyst

Indivior's data shows 300mg SUBLOCADE may benefit heavy fentanyl users, potentially expanding treatment efficacy in a critical patient segment.

The post-hoc analysis presented by Indivior reveals clinically meaningful improvements in opioid abstinence among heavy fentanyl users treated with the higher 300mg maintenance dose of SUBLOCADE compared to the 100mg dose. While this didn't reach statistical significance for the primary endpoint in the overall population, these findings are noteworthy given the growing prevalence of fentanyl in the opioid crisis.

The study demonstrated remarkable efficacy for both dosing regimens, with average weekly opioid use dropping from over 40 instances at screening to fewer than 3 by Week 3, with benefits sustained through Week 38. Importantly, no new safety concerns were identified with either dose, reinforcing SUBLOCADE's established safety profile.

This research addresses a critical treatment gap for patients with intense fentanyl use patterns, who typically represent the most challenging segment of the OUD patient population. The findings could potentially expand SUBLOCADE's clinical utility and market position in the medication for opioid use disorder (MOUD) space.

The company's additional research on treatment barriers in American Indian/Alaska Native populations shows strategic focus on addressing disparities in OUD care. Their multi-year claims analysis of over 75,000 AI/AN patients demonstrated that MOUD treatment reduced emergency department visits, supporting the clinical and economic value proposition of their treatments.

These collective findings strengthen Indivior's scientific position in the OUD treatment landscape and potentially create opportunities for expanded utilization of their 300mg SUBLOCADE formulation in specific high-need patient populations, particularly as fentanyl continues to drive the opioid epidemic.

• A post-hoc analysis demonstrates that buprenorphine exposure with 300 mg SUBLOCADE® (buprenorphine extended-release) may improve treatment outcomes among opioid use disorder (OUD) patients with heavy fentanyl use¹
• Additional Indivior-funded research identified OUD treatment barriers in American Indian/Alaska Native (AI/AN) people who are often affected by higher drug overdose death rates compared to other racial and ethnic groups^2-5

RICHMOND, Va., June 19, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq: INDV) presented new findings this week at the College on Problems of Drug Dependence (CPDD) Annual Scientific Meeting. A post hoc analysis showed that patients with heavier fentanyl use experienced clinically meaningful improvements in opioid abstinence when treated with a 300 mg maintenance dose of SUBLOCADE, compared to the 100 mg dose. While the 300 mg dose did not demonstrate a statistically significant advantage over 100 mg for weekly abstinence—the study's primary endpoint—in the overall population with moderate to severe opioid use disorder (OUD), the results suggest that higher doses of SUBLOCADE may offer better outcomes for individuals with high levels of fentanyl use.

"These findings offer additional evidence that the higher maintenance dose of SUBLOCADE is safe and may better support patients with intense fentanyl use patterns," said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. "We aim to provide clinicians with new data that can transform treatment strategies and support patients on their journey to recovery."

In the Indivior-funded study, patients with OUD who engaged in high-risk opioid use—such as injection use, high opioid dose consumption, or fentanyl use—received two initial 300 mg injections of SUBLOCADE one week apart. They were then randomized to receive eight monthly maintenance doses of either 100 mg or 300 mg. Both dosing regimens led to significant reductions in opioid use: the average weekly use dropped sharply from over 40 instances at screening to fewer than 3 by Week 3, and this improvement was sustained through Week 38. Notably, no new safety concerns were identified with either the 100 mg or 300 mg maintenance doses.

Indivior also funded research exploring OUD treatment access and outcomes in American Indian/Alaska Native (AI/AN) populations, which were presented at CPDD. AI/AN populations experience disproportionate rates of OUD, drug overdose, and gap in access to OUD care. A thematic analysis of focus group research on nine AI/AN advocates indicated that AI/AN people experience significant barriers to accessing medication for opioid use disorder (MOUD).^4-8 Barriers include stigma, institutional challenges, and transitions of care for OUD, highlighting opportunities for culturally appropriate interactive education and institutional advancement.²  These focus group findings are illustrative and can be used to identify avenues for future work, although they may not be generalizable to the full population.

In addition, a large multi-year longitudinal claims database analysis of more than 75,000 AI/AN patients with evidence of OUD showed differences in utilization of MOUD among those seeing Indian Health Services (IHS) vs. non-IHS providers. The majority of patients (73.1%) saw non-IHS providers. Patients treated with any form of MOUD had lower all-cause emergency department vs. those who were not treated with MOUD, highlighting the need for further research to understand MOUD utilization among AI/AN.

"The collective evidence from these presentations highlights prominent barriers to effective care and helps map out appropriate treatment approaches for individuals with OUD in challenging treatment settings," said Heidbreder. "Indivior focuses its scientific, treatment, and policy efforts on helping patients access the medications and support they need to recover."

Key Abstracts Presented at CPDD:

• Higher Exposures with 300-Mg Buprenorphine Extended-Release (BUP-XR) Increased the Proportion of Responders Among Opioid Use Disorder (OUD) Patients with Heavy Fentanyl Use
• Barriers to and Facilitators of Medication Treatment for Opioid Use Disorder Identified by American Indian/Alaska Native Advocates
• Utilization of Medications for Opioid Use Disorder (MOUD) and Patient Profiles Amongst American Indian/Alaska Native Managing Opioid Use Disorder (OUD)
• Polysubstance Use in Treatment for Opioid Use Disorder: Opioid Abstinence and Alternative Substance Use
• Clinical Outcomes and Recovery in Adults with Opioid Use Disorder: Long-term Treatment with Long- acting Injectable Buprenorphine under Real-World Conditions
• Severity and Symptomatology of Opioid Use Disorder (OUD) Among Individuals Reporting Pain Reliever Use, Pain Reliever Misuse, and/or Heroin Use: A Cross-sectional Analysis of the 2021 and 2022 National Survey on Drug Use and Health

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.

1. Higher Exposures with 300-Mg Buprenorphine Extended-Release (BUP-XR) Increased the Proportion of Responders Among Opioid Use Disorder (OUD) Patients with Heavy Fentanyl Use [Late Breaking Oral Sessions]. CPDD Annual Scientific Meeting, June 15, 2025.
2. Barriers To and Facilitators Of Medication Treatment for Opioid Use Disorder Identified by American Indian/Alaska Native Advocates [Oral Session: Expanding SUD interventions across populations]. CPDD Annual Scientific Meeting, June 17, 2025.
3. Utilization of Medications for Opioid Use Disorder (MOUD) and Patient Profiles amongst American Indian/Alaska Native Managing Opioid Use Disorder (OUD) [Poster Session 1]. CPDD Annual Scientific Meeting, June 15, 2025.
4. Indian Health Service. Disparities. 2019. Retrieved from https://www.ihs.gov/newsroom/factsheets/disparities/. Accessed: 16 May 2024.
5. Centers for Disease Control and Prevention, National Center for Health Statistics (2024). Rate of National Drug Overdose Deaths, By Demographic. Available at: https://nida.nih.gov/research-topics/trends- statistics/overdose-death-rates. Accessed: 6 Jun 2024.
6. Soto C, et al. (2022). International Journal of Environmental Research and Public Health, 19(5), 2974. doi:10.3390/ijerph19052974
7. Krawczyk N, et al. . Drug Alcohol Depend. 2021 Mar 1;220:108512. doi: 10.1016/j.drugalcdep.2021.108512
8. Mpofu, E, et al.. (2021). Addictive Behaviors, 114, 106743. doi:10.1016/j.addbeh.2020.106743

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SOURCE Indivior PLC

FAQ

What were the key findings of Indivior's SUBLOCADE study for fentanyl users?

The study showed that 300mg maintenance dose of SUBLOCADE may provide better outcomes for heavy fentanyl users, with opioid use reducing from 40 weekly instances to fewer than 3 by Week 3, sustained through Week 38.

Is INDV's 300mg SUBLOCADE dose more effective than the 100mg dose?

While the 300mg dose showed clinically meaningful improvements for heavy fentanyl users, it did not demonstrate statistically significant advantage over the 100mg dose for weekly abstinence in the overall OUD population.

What were the safety findings for Indivior's SUBLOCADE treatment?

No new safety concerns were identified with either the 100mg or 300mg maintenance doses of SUBLOCADE.

What did Indivior's research reveal about AI/AN opioid treatment patterns?

The research showed that 73.1% of AI/AN patients used non-IHS providers, and those treated with MOUD had lower emergency department visits, though significant barriers to treatment access exist.

How long did the positive effects of SUBLOCADE last in Indivior's study?

The reduction in opioid use was sustained from Week 3 through Week 38 of the study.