Indivior Publishes Exploratory Study Showing That Access to Medication for Opioid Use Disorder Varies Across Organized Health Systems in the U.S.
Published in Drug and Alcohol Dependence Reports, the study shows that identifying and overcoming barriers to appropriate use of medications to treat opioid use disorder (OUD) is critical to address the opioid crisis
Indivior PLC (LON: INDV) announced today a new analysis highlighting the results of an exploratory study analyzing real-world data of US distribution patterns of buprenorphine extended-release (BUP-XR also referred to as RBP-6000 or SUBLOCADE®), a monthly subcutaneous injection of buprenorphine that was approved by the FDA in November 2017 for the treatment of moderate-to-severe OUD,1 within organized health systems (OHS). The study titled “The Introduction of a Novel Formulation of Buprenorphine Into Organized Health Systems” was published in the August online issue of Drug and Alcohol Dependence Reports, a peer-reviewed journal.
This exploratory study used real-world evidence to identify barriers to medications for opioid use disorder (MOUD) treatment by analyzing the distribution patterns of BUP-XR over the 12-month period from July 2019 to July 2020 across four OHS subtypes including Integrated Delivery Networks (IDNs), Veterans Health Administration (VHA), Criminal Justice System (CJS), and Indian Health Services (IHS).
In addition to assessing the national distribution patterns of BUP-XR across OHS subtypes, this study also evaluated the distribution of BUP-XR within each subtype over time.
Overall, the distribution of BUP-XR as a treatment option for patients with OUD increased within OHS but occurred at different rates across OHS subtypes. Numerous barriers within each OHS subtype impede access to MOUD, despite evidence in support of their effectiveness in reducing morbidity and mortality from OUD, increasing treatment retention, and improving the quality of life of patients with OUD.
“Removing system-level, provider-level, and local-level barriers to quality treatment and integrating OUD treatment into routine care and other settings are critical steps to ensuring access to evidence-based MOUD and represent a cornerstone of the opioid crisis response in the United States,” said Christian Heidbreder, PhD, Chief Scientific Officer, Indivior.
Study findings within each OHS Subtype:
Integrated Delivery Networks
- IDNs contributed a significant percentage of the overall national distribution of BUP-XR and showed higher BUP-XR growth over time compared with other OHS subtypes.
- While access to BUP-XR is better for patients with OUD in IDNs than in other OHS subtypes, it is still limited.
Veterans Health Administration
- Relatively few VHA patients received BUP-XR, despite efforts in facilitating the extensive provision of MOUD and policies requiring it to be available and despite encouraging results supporting the use of BUP-XR as a useful treatment option for complex treatment-resistant veterans with significant medical and psychosocial co-morbidities.
- The VHA has implemented several nationwide initiatives to share best practices and increase education. States with the highest distribution of BUP-XR may be the result of more progressive institutions that have readily adopted new programs and policies to treat their OUD population.2
Criminal Justice System
- CJS continues to see steady adoption of LAIs for OUD, although overall MOUD uptake has been slow to be incorporated into routine practice in this OHS subtype.
Indian Health Services
- The IHS, primarily serving American Indians and Alaska Natives, showed the slowest adoption of LAIs for the treatment of OUD. This population is particularly vulnerable to OUD with national death rates due to OUD in 2018 the second highest in the U.S. after white and non-Hispanic people.3
Please view the full publication here to access the full study results.
About SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII
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
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WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION;
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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.
About Indivior
Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat substance use disorders (SUD) 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, including alcohol use disorder and cannabis use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 900 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:
US
IndiviorMediaContacts@indivior.com
+1 804-594-0836
UK
Tulchan Communications
+44 207-353-4200
Investor Contact:
Jason Thompson
Vice President, Investor Relations
Indivior PLC (LON: INDV)
804-402-7123
References:
1. SUBLOCADE® [Prescribing Information]. Indivior Inc., North Chesterfield, VA. June 2021.
2. Wyse, J.J., Gordon, A.J., Dobscha, S.K., Morasco, B.J., Tiffany, E., Drexler, K., Sandbrink, F., Lovejoy, T.I., 2018. Medications for opioid use disorder in the Department of Veterans Affairs (VA) health care system: historical perspective, lessons learned, and next steps. Substance abuse 39(2), 139-144.
3. Wilson, N., Kariisa, M., Seth, P., Smith, H.I., L., D.N., 2020. Drug and opioid-involved overdose deaths—United States, 2017–2018. MMWR Morb. Mortal. Wkly. Rep. 69(11), 290.