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Indivior Presents Study at the 2021 National Commission on Correctional Health Care Conference on Factors Impacting Medications for Opioid Use Disorder Treatment Approaches in Criminal Justice-Involved Populations

 

Richmond, VA, November 1, 2021 - Indivior PLC (LON: INDV) announced today the presentation of data at the National Commission on Correctional Healthcare Conference (NCCHC) from a mixed methods study examining opioid use disorder (OUD) treatment barriers in the criminal justice system.1 The study entitled, Factors Impacting Medication for Opioid Use Disorder (MOUD) Treatment Decisions in Criminal Justice-involved Populations, demonstrated factors influencing treatment approaches including preferred treatment options, barriers to treatment, and patient concerns.1 The National Correctional Health Care Conference takes place from October 30 to November 3, 2021.

The mixed methods study included a systematic review of peer-reviewed literature published between 2016-2021 and semi-structured interviews with eight addiction medicine specialists, primary care physicians, and clinical and administrative team members working in and with Tower Health, an integrated health system in Pennsylvania. Additionally, sample data from electronic health records (EHR) of 195 patients treated with MOUD was analyzed to predict patient-related outcomes such as number of emergency department (ED) visits and clinic no-shows compared with criminal justice involved individuals and non-criminal justice involved individuals. 1  

“It is estimated that nearly 20 percent of individuals sentenced to state prison report regular use of opioids,”2 said Christian Heidbreder, Chief Scientific Officer, Indivior. “Stigma and lack of resources has resulted in unequal access to treatment for people who are incarcerated. We must continue to advocate for expanded access to medication for opioid use disorder treatment in correctional settings and focus our efforts on helping people access the treatments they need to achieve and maintain recovery.”

The qualitative analysis included interviews with participants to gauge their opinions regarding MOUD treatment for criminal justice-involved populations.1 The interviews revealed that all eight addiction medicine team members favored the use of the monthly injectable version of buprenorphine for most people with OUD. Study participants also indicated patients expressed anxiety about trying a new medication and having concerns of withdrawal as a component of treatment decisions, among other factors.1

The statistical analysis from sample electronic health records EHR data revealed that when patients were offered MOUD treatment, likelihood of ED visits or clinic no-shows were the same for criminal justice-involved patients and non-criminal justice-involved patients.1

Additionally, the data presented also showed that individuals with criminal justice-involvement face greater limitations in access to treatment than patients with no involvement in the criminal justice system.1

About the study methods

The mixed methods study included a systematic literature review, in-depth interviews with addiction medicine specialists working in and with Tower Health, an integrated health system in Pennsylvania, and analysis of a sample from the Tower Health Electronic Health Record. Logistic regression models were used to estimate associations of various factors with emergency department visits and clinic no-show rates among patients being treated with MOUD. The study explored factors influencing treatment approaches, including the use of the monthly injectable version of buprenorphine, for individuals with OUD, with a particular focus on patients with CJI.1

Study limitations included the involvement of one health system and a small number of patient health records. Additionally, criminal justice-involvement was identified through review of electronic health records (EHR) documentation which relies on providers asking about criminal justice-involvement and patient self-reports.

About Indivior

Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat addiction 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 addiction. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence 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 cooccurring disorders of addiction, including alcohol use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 800 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

 

Media Contacts:

UK

Tulchan Communications

+44 207-353-4200

US

Jennifer Ginther

Director, Communications

Mobile: 804-467-1593

 

Investor Contact:

Jason Thompson

Vice President, Investor Relations

Indivior PLC (LON: INDV)

Mobile: 804-402-7123

References:

  1. Bailey K, Gusmano M, Millen W et al. (2021) Factors impacting MOUD treatment decisions in criminal justice-involved populations.
  2. SAMHSA. Medication Assisted Treatment (MAT) in the Criminal Justice System.  Brief Guidance to the States. Published March 2019. https://store.samhsa.gov/sites/default/files/d7/priv/pep19-matbriefcjs_0.pdf

 

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 transmucosal 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.

 

Prescription use of this product is limited under the Drug Addiction Treatment Act.

CONTRAINDICATIONS

SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of the ATRIGEL® 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 pruritis 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.