Indivior Announces Four Abstracts Accepted for Presentation at the 85th Annual Scientific Meeting of the College on Problems of Drug Dependence
RICHMOND, Va., June 14, 2023 - 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
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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
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WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY
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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.
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.
Media Contacts:
US Media:
Ben Atkins
Vice President, Communications
Indivior PLC
Tel: 424-844-3244
UK Media:
Teneo
Tel: +44 207-353-4200
Investors and Analysts:
Jason Thompson
Vice President, Investor Relations
Indivior PLC
Tel: 804-402-7123
Tim Owens
Director, Investor Relations
Indivior PLC
Tel: 804-263-3978
References:
1. 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.