Indivior Highlights Growing Body of Data on SUBLOCADE® (buprenorphine once-monthly extended-release injection) Helping Patients Achieve Long-Term Recovery from Opioid Use Disorder during Substance Abuse Prevention Month

• Evidence demonstrates that SUBLOCADE supports long-term recovery from opioid use disorder (OUD) and is effective and safe.
• Publications highlight the importance of overcoming access barriers to long-acting injectable treatments for OUD

RICHMOND, Va., Oct. 30, 2024 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV), in recognizing Substance Abuse Prevention Month, provides an update on key findings from the last year that demonstrate the importance of access to medications for the treatment of opioid use disorder (MOUD) and the effectiveness and safety of SUBLOCADE® in the treatment of OUD. These data add to the growing body of evidence that SUBLOCADE can improve outcomes, such as abstinence, retention, and recovery in persons with OUD.

Publications

• In a post hoc analysis of the SUBLOCADE randomized, double-blind, placebo-controlled phase 3 clinical trial, published in Harm Reduction Journal, SUBLOCADE 300 mg maintenance dose resulted in a statistically significant increase in abstinence from opioids among study participants with OUD who injected opioids compared to 100 mg maintenance dose. However, both were equally effective in non-injecting participants.
• Results from the Community Long-Acting Buprenorphine (CoLAB) Study, a prospective single-arm, multicenter, open label trial in Australia, were published in the International Journal of Drug Policy, and demonstrated that participants could be maintained on SUBLOCADE treatment for 96 weeks with continuous improvements in abstinence, depression, quality of life and medication satisfaction.
• In a qualitative research survey of 20 participants representing various practice settings, published in American Health & Drug Benefits, it was determined that telemedicine was the most common solution adopted during the COVID-19 pandemic to overcome access barriers. However, today there are still significant challenges in ensuring appropriate access to medications for those living with OUD and continued support, effective solutions and policies in the United States, need to be continually addressed.
• In a narrowly focused literature, policy, and legal proceedings review, published in Corrections Today, a clear disparity in access to MOUD was found between the general public and incarcerated individuals. Stigma and informed consent were the most discussed barriers used to justify policies limiting MOUD for incarcerated individuals.

Presentations

Multiple real-world evidence poster presentations highlight challenges and opportunities in treating persons with OUD.

• 2024 American Association of Psychiatric Pharmacists, April 7-10, Orlando FL
  • Title: Emergency Room (ER) Visits Among Opioid Use Disorder (OUD) Patients
  • Title: Opioid Treatment Programs, Healthcare Resource Utilization, and Healthcare Costs among Patients Initiating Treatment with Buprenorphine Extended-Release
• 2024 American Telemedicine Association Nexus, May 5-7, Phoenix AZ
  • Title: Impact of Telemedicine on Medication for Opioid Use Disorder Retention during the SARS-CoV-2 Pandemic Period Among Patients with OUD
• 2024 College on Problems of Drug Dependence, June 15-19, Montreal Quebec Canada
  • Title: Buprenorphine Treatment After an Emergency Department Visit for Non-Fatal Opioid Overdose
  • Title: Pain Predicts Abstinence During Treatment of Opioid Use Disorder for Individuals Reporting Moderate to Severe Pain
  • Title: A Randomized Open-Label Study Comparing Rapid and Standard Inductions to Injectable Buprenorphine Extended-Release (BUP-XR) Treatment
  • Title: A Mechanistic Pharmacological Model to Predict and Inform Effective Buprenorphine Treatment Induction Strategies in the Era of Synthetic Opioids
• 2024 U.S. Public Health Service Scientific & Training Symposium, June 24-27, Jacksonville FL
  • Title: Clinical and Treatment Characteristics of American Indian/Alaska Native Patients Managing Opioid Use Disorder Compared to the General US Population
• BUPE2024 – Buprenorphine in Medicine: Clinical and Public Policy Implications, August 5, Virtual conference
  • Title: Healthcare Utilization and Costs Associated with Management of Opioid Use Disorder (OUD) within Residential Treatment Programs (RTP) and Office-Based Opioid Treatment Programs (OBOT)
• 2024 National Commission on Correctional Health Care (NCCHC) Annual, October 19-23, Las Vegas, NV
  • Title: Outcomes Associated with Medications for Opioid Use Disorder in the Carceral System: A Systematic Literature Review
  • Title: Diversion of Medications for OUD in the Criminal Justice System

Dr. Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior, emphasized, “The collective evidence highlights the importance of access to Medications for OUD, such as SUBLOCADE, in reducing barriers to adherence and improving outcomes for individuals in recovery. Indivior is committed to continuing to advance the understanding of patients with OUD, educate on evidence-based practices, overcome stigma, and focus on recovery outcomes.”

Among the almost 6 million people aged 12 or older with a past year opioid use disorder in 2023, only 18% (or one million people) received treatment through MOUD.¹

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 buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.

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 called 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

SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of Indivior’s proprietary buprenorphine gel depot delivery system.

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.

Opioids can cause sleep-related breathing disorders e.g., central sleep apnea (CSA), sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. Consider decreasing the opioid using best practices for opioid taper if CSA occurs.

Strongly consider prescribing naloxone at SUBLOCADE initiation or renewal because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. Educate patients and caregivers on how to recognize respiratory depression and how to treat with naloxone if prescribed.

Risk of Serious Injection Site Reactions: The most common injection site reactions are pain, erythema and pruritus with some involving abscess, ulceration, and necrosis. The likelihood of serious injection site reactions may increase with inadvertent intramuscular or intradermal administration.

Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome 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 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 patient is clinically stable on 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.² OUD may affect the parts of the brain that are necessary for life-sustaining functions.^2,3

About Indivior

Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat substance use disorders (SUD), overdose and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD 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 both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD. 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.

References

1. Substance Abuse and Mental Health Services Administration. (2024). Key substance use and mental health indicators in the United States: Results from the 2023 National Survey on Drug Use and Health (HHS Publication No. PEP24-07-021, NSDUH Series H-59). Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration.

   Key Substance Use and Mental Health Indicators in the United States: Results from the 2023 National Survey on Drug Use and Health (samhsa.gov)

2. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Medication-Assisted Treatment for Opioid Use Disorder, Mancher, M., & Leshner, A. I. (Eds.). (2019). Medications for Opioid Use Disorder Save Lives. National Academies Press (US). Accessed October 30, 2023, from https://www.ncbi.nlm.nih.gov/books/NBK538936/pdf/Bookshelf_NBK538936.pdf
3. NIDA. 2022, March 22. Drugs and the Brain. Accessed October 30,2023, from https://nida.nih.gov/publications/drugs-brains-behavior-science-addiction/drugs-brain

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