Press Releases

Indivior to Present New Data on Buprenorphine Extended-Release at the 2021 Joint International Congress with ALBATROS and the World Association on Dual Disorder (WADD)

Richmond, VA, December 8, 2021 - Indivior PLC (LON: INDV) today announced the presentation of new data on the efficacy of extended-release buprenorphine (SUBLOCADE®) in subgroups of adults with moderate to severe opioid use disorder (OUD)1 and an encore presentation on a study focusing on Fentanyl users2 at the Joint International Congress with ALBATROS and the World Association on Dual Disorder (WADD) taking place in Paris, France on December 7-9th, 2021.

The subgroup analysis entitled “Examining efficacy and safety of extended-release buprenorphine in subgroup of subjects with moderate to severe opioid use disorder”, performed using the data from a pivotal randomized controlled study3, examined whether changes in age, gender, BMI, intravenous drug use, polydrug use, underlying liver conditions or psychiatric illness were associated with changes in primary and secondary efficacy endpoints and/or changes in treatment emergent adverse events (TEAEs), serious adverse events (SAEs), AEs leading to death and AEs leading to treatment discontinuation. The results showed that the safety and efficacy of SUBLOCADE® was consistent across subgroups compared to placebo.1 In the safety analysis, AEs per subgroup were generally similar to the overall incidence of AEs. Participants with a history of psychiatric conditions had a modest increase in AEs, TEAEs and SAEs relative to subjects without a psychiatric disorder.1

“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," said Christian Heidbreder, Chief Scientific Officer, Indivior. “It is imperative to understand the safety and efficacy of SUBLOCADE for all patients across the globe, including sub-populations of subjects.”

About the Study

Adults (n = 489) with moderate or severe OUD were randomized to SUBLOCADE® 300/100mg, 300/300mg (2 initial monthly injections of 300mg followed by 4 monthly maintenance doses of 100mg or 300mg), or placebo for 24 weeks. Opioid abstinence assessment was based on weekly opioid-negative urine samples and negative self-reports.1



SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use (CIII)



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.





  • 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.


Prescription use of this product is limited under the Drug Addiction Treatment Act.



SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of the ATRIGEL® delivery system



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 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


About Indivior

Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat substance use disorders (SUD) 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 opioid use disorder 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. Headquartered in the United States in Richmond, VA, Indivior employs more than 900 people globally and its portfolio of products is available in over 40 countries worldwide. Visit to learn more. Connect with Indivior on LinkedIn by visiting


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.



Media Contacts:


Tulchan Communications

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Jennifer Ginther

Director, Communications

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Jason Thompson

Vice President, Investor Relations

Indivior PLC (LON: INDV)

Mobile: 804-402-7123



  1. Wiest, et. al. Examining efficacy and safety of extended-release buprenorphine in subgroups of subjects with moderate to severe opioid use disorder; Presenting at the Joint International Congress with ALBATROS and the World Association on Dual Disorder (WADD); December 7-9, 2021.
  2. Mariani, et. al. Rapid Initiation of Extended Release Buprenorphine in Patients using Fentanyl and Fentanyl Analogs. Presented at Canadian Society of Addiction Medicine - La Société Médicale Canadienne sur L’Addiction (CSAM-SMCA); October 21-23, 2021.
  3. Haight, B. R., et al. (2019). "Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial." Lancet 393(10173): 778-790.
  4. SUBLOCADE® [Prescribing Information]. Indivior Inc., North Chesterfield, VA. June 2021.
  5. 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
  6. Substance Abuse and Mental Health Services Administration. (2020). Key Substance Use and Mental Health Indicators in the United States: Results from the 2020 National Survey on Drug Use and Health. HHS Publication No. PEP21-07-01-003, NSDUH Series H-56. Rockville, MD: Center for Behavioural Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from . Accessed on November 3, 2021.