Indivior to Present New Data on Opioid Use Disorder at CSAM-SMCA 2021 Scientific Conference

RICHMOND, Va., Oct. 21, 2021 /PRNewswire/ -- Indivior PLC (LON: INDV) today announced the presentation of new data from multiple posters and presentations at the Canadian Society of Addiction Medicine – La Société Médicale Canadienne sur L'addiction (CSAM-SMCA) 2021 Scientific Conference, taking place virtually October 21-23, 2021.

"Indivior is committed to developing science-based treatment options for patients suffering from opioid use disorder and bridging the gap between efficacy and safety in the research setting and the use of medications in the real-world setting," said Christian Heidbreder, Chief Scientific Officer at Indivior. "We are generating data to help the healthcare community understand the unique challenges faced by patients with opioid use disorder and potential ways to overcome them."

The abstracts accepted for presentation are as follows:

Mariani, et. al. Rapid Initiation of Extended-Release Buprenorphine in Patients using Fentanyl and Fentanyl Analogs¹

Lee, et al. Real-World Evidence for the Optimal Management of Opioid Use Disorder (OUD) During COVID-19 pandemic for Patients receiving Opioid Agonist Treatment (OAT)²

Wiest, et. al. Initiating Monthly Buprenorphine Injection After Single Dose of Sublingual Buprenorphine (Encore presentation)³

Keith et. al. Struggling with Recovery from Opioids: Who is at Risk During COVID-19 (Encore presentation)⁴

Wiest, et. al. Examining the benefit of RBP-6000 300mg versus 100mg maintenance dose in opioid injectors (Encore presentation)⁵

About Opioid Use Disorder (OUD)

Opioid use disorder (OUD) is not a moral weakness; it is a chronic relapsing disorder⁶ that may affect the parts of the brain that are necessary for life-sustaining functions.⁷

In 2019, an estimated 9.5 million people aged 18 or older misused opioids in the past year, including 9.2 million prescription pain reliever misusers and 745,000 heroin users.⁸

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 addiction. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence 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 addiction, including alcohol use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 700 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

This announcement contains certain statements that are forward-looking. 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. Forward-looking statements include, among other things, statements regarding the Indivior Group's financial guidance for 2021, and its medium- and long term growth outlook, its operational goals, its product development pipeline and statements regarding ongoing litigation and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions.

Various factors may cause differences between Indivior's expectations and actual results, including, among others (including those described in the risk factors described in the most recent Indivior PLC Annual Report and in subsequent releases): factors affecting sales of Indivior Group's products and financial position; the outcome of research and development activities; decisions by regulatory authorities regarding the Indivior Group's drug applications or authorizations; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved, if at all; the outcome of post approval clinical trials; competitive developments; difficulties or delays in manufacturing and in the supply chain; disruptions in or failure of information technology systems; the impact of existing and future legislation and regulatory provisions on product exclusivity; trends toward managed care and healthcare cost containment; legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access; challenges in the commercial execution; claims and concerns that may arise regarding the safety or efficacy of the Indivior Group's products and product candidates; risks related to legal proceedings, including compliance with the U.S. Department of Justice Resolution and Settlement Agreements, noncompliance with which could result in potential exclusion from participating in U.S. Federal health care programs; the ongoing investigative and antitrust litigation matters; the opioid national multi-district litigation and securities class action litigation; the Indivior Group's ability to protect its patents and other intellectual property; the outcome of patent infringement litigation relating to Indivior Group's products, including the ongoing ANDA lawsuits; changes in governmental laws and regulations; issues related to the outsourcing of certain operational and staff functions to third parties; risks related to the evolving COVID-19 pandemic and the potential impact of COVID-19 on the Indivior Group's operations and financial condition, which cannot be predicted with confidence; uncertainties related to general economic, political, business, industry, regulatory and market conditions; and the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other unusual items.

Consequently, 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. You should not place undue reliance on forward-looking statements. We cannot guarantee future results, events, levels of activity, performance or achievements. 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:

1. Mariani, et. al. Rapid Initiation of Extended Release Buprenorphine in Patients using Fentanyl and Fentanyl Analogs. Presenting at Canadian Society of Addiction Medicine - La Société Médicale Canadienne sur L'Addiction (CSAM-SMCA); October 21-23, 2021.
2. Lee, et al. Real-World Evidence for the Optimal Management of Opioid Use Disorder (OUD) During COVID-19 pandemic for Patients receiving Opioid Agonist Treatment (OAT).  Presenting at Canadian Society of Addiction Medicine - La Société Médicale Canadienne sur L'Addiction (CSAM-SMCA); October 21-23, 2021.  
3. Wiest, et. al. Initiating Monthly Buprenorphine Injection After Single Dose of Sublingual Buprenorphine. #W102; Presented at College on Problems of Drug Dependence (CPDD); June 23, 2021.
4. Keith et. al. Struggling with Recovery from Opioids: Who is at Risk During COVID-19.; Presented at College on Problems of Drug Dependence (CPDD), Late Breaking Oral Presentation II-COVID; June 21, 2021.   Abstract No. XXXX, Oral Presentation; Session Number; Date and Time
5. Wiest, et. al. Examining the benefit of RBP-6000 300mg versus 100mg maintenance dose in opioid injectors.; Presented at College on Problems of Drug Dependence (CPDD), June 23, 2021.
6. Rethink Opioid Addiction. Accessed May 28, 2021. https://www.rethinkopioidaddiction.com/
7. 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
8. Substance Abuse and Mental Health Services Administration. (2020). Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health (HHSPublication No. PEP20-07-01-001, NSDUH Series H-55). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data/. Accessed on September 13, 2021

SOURCE Indivior

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