RICHMOND, Va., June 14,
2023 /PRNewswire/ -- Indivior PLC (LSE/Nasdaq: INDV)
today announced the acceptance of four abstracts for presentation
at the 85th Annual Scientific Meeting of the College on
Problems of Drug Dependence (CPDD) taking place June 17-21, 2023, in Denver, Colorado. The abstracts cover
experiences of patients with cannabis use disorder (CUD) and
patients with opioid use disorder (OUD) treated with
extended-release buprenorphine.
"These data shed new light on how people with OUD or CUD manage
their daily life challenges toward recovery," said Christian Heidbreder, PhD, Chief Scientific
Officer, Indivior. "We can better grasp the obstacles to, and
factors that motivate, recovery in real-world situations over the
long-term by learning more about patients' behaviors and approaches
to their disease."
Details of the data presentations:
Poster Presentation Title: Association between
ongoing illicit fentanyl use and risk for non-fatal overdose among
patients treated with opioid agonist therapy in Canada
Authors: Kenneth Lee, Yue
Zhao, Tazmin Merali, Chris Fraser, Jan-Marie
Kozicky, and Brian Conway
Poster Number; Session; Date/Time: Poster No. S71, Poster
Session 1; Sunday, June 18 2023; 5:15
– 6:15pm
Poster Presentation Title: Pain in Opioid Use Disorder
Recovery: Is Pain Severity or Chronicity a Stronger Predictor of
Health Outcomes?
Authors: William H. Craft,
Allison N. Tegge, Candice L. Dwyer, Devin
C. Tomlinson, Diana R. Keith,
Liqa N. Athamneh, Jeffrey S. Stein,
Anne Le Moigne, Angela M. DeVeaugh-Geiss, Howard D. Chilcoat, and Warren K. Bickel
Poster Number; Session; Date/Time: Poster No. S92, Poster
Session 1; Sunday, June 18, 2023;
5:15 – 6:15pm
Poster Presentation Title: Cumulative Vulnerabilities: An
Investigation of Lifetime Substance Use Among Individuals in
Recovery from Opioid Use Disorder
Authors: Devin C. Tomlinson, Allison N. Tegge, Roberta Freitas-Lemos, William H. Craft, Anne
Le Moigne, Angela M.
DeVeaugh-Geiss, Howard D.
Chilcoat, Stephen T. Higgins,
and Warren K. Bickel
Poster Number; Session; Date/Time: Poster No. W41, Poster
Session 4; Wednesday, June 21, 2023;
2:00 – 3:30pm
Poster Presentation Title: Cannabis Use Disorder Symptom
Profiles Among Individuals Reporting Past-year Cannabis Use in
the United States
Authors: Angela M.
DeVeaugh-Geiss, John J.
Marian2, Beth A.
Reboussin, and Howard D. Chilcoat
Poster Number; Session; Date/Time: Poster No. M60, Poster
Session 2; Monday, June 19, 2023;
5:00 – 6:30pm
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This Press release is not sanctioned by the College on Problems
of Drug Dependence
+++
About SUBLOCADE®
SUBLOCADE (buprenorphine
extended-release) injection, for subcutaneous use (CIII)
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
See full
prescribing information for complete boxed warning
- Serious harm or death could result if
administered intravenously.
- 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 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 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.1 OUD may affect the parts of the brain
that are necessary for life-sustaining functions.1
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 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.
Forward-Looking Statements
Important Cautionary Note Regarding Forward-Looking
Statements
This news release contains certain statements that are
forward-looking. Forward-looking statements include, among other
things, express or implied statements regarding the efficacy of
potential new productor or therapies, and other statements
containing the words "believe", "anticipate", "plan", "expect",
"intend", "estimate", "forecast," "strategy," "target," "guidance,"
"outlook," "potential", "project", "priority," "may", "will",
"should", "would", "could", "can", "outlook," "guidance", the
negatives thereof, and variations thereon and similar expressions.
By their nature, forward-looking statements involve risks and
uncertainties as they relate to events or circumstances that may or
may not occur in the future.
Actual results may differ materially from those expressed or
implied in such statements because they relate to future events.
Various factors may cause differences between Indivior's
expectations and actual results, including, among others, the
material risks described in the most recent Indivior PLC Annual
Report and in subsequent releases; the substantial litigation and
ongoing investigations to which we are or may become a party; our
reliance on third parties to manufacture commercial supplies of
most of our products, conduct our clinical trials and at times to
collaborate on products in our pipeline; our ability to comply with
legal and regulatory settlements, healthcare laws and regulations,
requirements imposed by regulatory agencies and payment and
reporting obligations under government pricing programs; risks
related to the manufacture and distribution of our products, some
of which are controlled substances; market acceptance of our
products as well as our ability to commercialize our products and
compete with other market participants; the uncertainties related
to the development of new products, including through acquisitions,
and the related regulatory approval process; our dependence on a
small number of significant customers; our ability to retain key
personnel or attract new personnel; our dependence on third-party
payors for the reimbursement of our products and the increasing
focus on pricing and competition in our industry; unintended side
effects caused by the clinical study or commercial use of our
products; our use of hazardous materials in our manufacturing
facilities; our import, manufacturing and distribution of
controlled substances; our ability to successfully execute
acquisitions, partnerships, joint ventures, dispositions or other
strategic acquisitions; our ability to protect our intellectual
property rights and the substantial cost of litigation or other
proceedings related to intellectual property rights; the risks
related to product liability claims or product recalls; the
significant amount of laws and regulations that we are subject to,
including due to the international nature of our business;
macroeconomic trends and other global developments such as the
COVID-19 pandemic; the terms of our debt instruments, changes in
our credit ratings and our ability to service our indebtedness and
other obligations as they come due; changes in applicable tax rate
or tax rules, regulations or interpretations; and our ability to
realize our deferred tax assets.
Forward-looking statements speak only as of the date that they
are made and should be regarded solely as our current plans,
estimates and beliefs. Except as required by law, we do not
undertake and specifically decline any obligation to update,
republish or revise forward-looking statements to reflect future
events or circumstances or to reflect the occurrences of
unanticipated events.
References:
- U.S. Department of Health and Human Services (HHS), National
Institute on Drug Abuse, National Institutes of Health. Drugs,
Brains, and Behavior: The Science of Addiction. HHS Publication No.
(SMA) 18-5063PT5, Printed 2018.
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