Indivior Publishes Real World Data Showing SUBLOCADE® May Reduce Non-Fatal Overdoses Among Individuals with Opioid Use Disorder in Canada

Rhea-AI Summary

Rates of non-fatal overdose events were lower with SUBLOCADE treatment compared to other therapies, according to a study published in the Journal of Addiction Medicine. The study found that SUBLOCADE had a lower incidence rate of non-fatal opioid overdoses (1.7%) compared to sublingual buprenorphine/naloxone (19.3%) and methadone (46.8%), with statistically significant risk-adjusted differences of 6.5% and 8.6% respectively. The study also showed improvements in other clinical parameters. Further studies are needed to validate these findings.

Positive

• SUBLOCADE treatment associated with lower rates of non-fatal opioid overdoses compared to other therapies

Negative

• None.

• Rates of non-fatal overdose events following SUBLOCADE treatment was lower compared to daily opioid agonist therapy.
• Data published in the Journal of Addition Medicine

RICHMOND, Va., Sept. 26, 2023 /PRNewswire/ -- Indivior PLC (LSE/Nasdaq: INDV) today announced the publication of a retrospective chart review analysis of individuals treated for opioid use disorder (OUD) demonstrating that in Canada SUBLOCADE® (buprenorphine extended-release) Injection was associated with a lower incidence rate (number of events per 100 person-years) of self-reported, non-fatal opioid overdoses (1.7%) compared with sublingual buprenorphine/naloxone (19.3%) or methadone (46.8%) leading to a statistically significant risk adjusted difference of 6.5% (P=0.0115) and 8.6% (P=0.0022), respectively. The study was published online in the Journal of Addiction Medicine.

This study, conducted during the COVID-19 pandemic in Canada, also showed improvements in additional parameters suggestive of clinical benefit. The percentage of individuals with urinary drug screen (UDS)-detected fentanyl use within the first month of treatment was 23% with SUBLOCADE; 22% with sublingual buprenorphine/naloxone, and 66% with methadone. During the six months following the initiation of treatment, UDS-detected fentanyl use decreased to 13% with SUBLOCADE, 10% with sublingual buprenorphine/naloxone, and 51% with methadone. When adjusted for both monthly fentanyl use and baseline clinical characteristics, methadone (OR_adj2=22.43; 95% CI, 2.66–188.97) and sublingual buprenorphine/naloxone (OR_adj2=17.30; 95% CI, 1.69–177.14) both exhibited greater odds of non-fatal overdose than SUBLOCADE.

Given the naturalistic, retrospective design, further prospective studies are needed to validate these findings.

"This study shows the potential positive impact of using SUBLOCADE in OUD treatment to help reduce non-fatal opioid overdoses in Canada, including from fentanyl use," said Christian Heidbreder, PhD, Chief Scientific Officer, Indivior.

Based on data published in June 2023, the Public Health Agency of Canada reported approximately 7,500 opioid-induced deaths in the 2022 calendar year.¹ In the United States, the 12-month-ending provisional number of reported opioid overdose deaths reached 79,644 in February 2023. The reported overdose deaths linked to synthetic opioids was 72,240 representing 90% of all opioid overdose fatalities.²

"Restrictions during the pandemic resulted in fewer interactions between people with OUD and health care providers, disrupting normal patterns of care and accessibility of treatment," said Kenneth Lee, MD, MCFP (AM) medical director of the London Rapid Access Addiction Medicine (RAAM) Clinic, London ON, Canada and the principal investigator of the study. "Treatment options for OUD were limited at the time, but the SUBLOCADE injection provided a long-acting option, which may benefit the patients to avoid using high potency illicit opioids."

About the Study

The aim of this retrospective chart review was to determine if opioid agonist therapy (OAT) with SUBLOCADE, sublingual buprenorphine/naloxone, or methadone decreased non-fatal overdoses in Canada. The chart review included 379 cases of individuals with OUD, initiated on OAT between March 11, 2020 - October 31, 2021, and included 128 individuals initiated on SUBLOCADE, 139 initiated on sublingual buprenorphine/naloxone, and 112 initiated on methadone. Data were collected from 9 treatment sites in British Columbia and Ontario Canada. The charts consistently followed these individuals for at least 6 months. Mean age was 40 years, and 64% were male. OAT retention rates were high. Seventy-eight percent of individuals initiated on prescribed SUBLOCADE remained on the treatment for the 6 months; 62% and 80% remained on sublingual buprenorphine/naloxone or methadone, respectively, following initiation. No fatal overdoses occurred during the study period.

This study has inherent limitations related to its retrospective, observational design, and reliance on self-report to identify non-fatal overdoses. A prospective study to validate these results is needed to demonstrate the potential role of SUBLOCADE in addressing the opioid crisis.

This study was supported by Indivior and was published in the Journal of Addiction Medicine. August 11, 2023. DOI 0000000000001213

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.³ OUD may affect the parts of the brain that are necessary for life-sustaining functions.³

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 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 1000 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.

References

1. Federal, provincial, and territorial Special Advisory Committee on the Epidemic of Opioid Overdoses. Opioid- and Stimulant-related Harms in Canada. Ottawa: Public Health Agency of Canada; June 2023. Accessed 2023 July 31.  Available from https://health-infobase.canada.ca/substance-related-harms/opioids-stimulants/graphs?index=15
2. Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. July 2023. Accessed 2023    July 18. Available from   https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. 
3. NIDA. 2022, March 22. Drugs and the Brain.  Accessed 2023, July 18 https://nida.nih.gov/publications/drugs-brains-behavior-science-addiction/drugs-brain 

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SOURCE Indivior PLC