- 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 (ORadj2=22.43; 95%
CI, 2.66–188.97) and sublingual buprenorphine/naloxone
(ORadj2=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
- 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
- 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.
- 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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