Indivior : Presents New Data at the College on Problems of Drug Dependence (CPDD) 2021 Annual Conference

Indivior Presents New Data at the College on Problems of Drug Dependence (CPDD)

2021 Annual Conference

Richmond, VA, June 24, 2021- Indivior PLC (LON: INDV) announces the presentation of new data from three posters and one late-breaking oral presentation at the College on Problems of Drug Dependence (CPDD) 83rdAnnual Scientific VirtualMeeting taking place June 21-24, 2021.

Data presented include an assessment of substance use during COVID-19 in a sample of participants in recovery from opioid use disorder (OUD) in the United States, a post-hoc analysis of the efficacy and safety of different maintenance doses of extended-release buprenorphine in participants who used opioids via the injection route, a study assessing the safety and tolerability of initiating extended-release buprenorphine after administration of a single dose of 4 mg transmucosal buprenorphine, and a real- world implementation study of extended-release buprenorphine in people with OUD in diverse community healthcare settings in Australia.1,2,3,4

"Indivior is committed to furthering the scientific understanding of substance use disorders, including opioid use disorder, and to providing data that may help clinicians determine how best they can help patients," said Christian Heidbreder, Chief Scientific Officer, Indivior. "The COVID-19 pandemic is having a devastating impact on the opioid crisis in the U.S. More than 90,000 people died from drug overdose in the 12-month period ending November 2020, and approximately 67,574 of these deaths are attributable to opioids.5We must focus our scientific, treatment and policy efforts on helping patients access the treatment supports they need to move onto a path to recovery."

Indivior Sponsored Studies:

Struggling with recovery from opioids: Who is at risk during COVID-19? (Oral presentation) assessed substance use duringCOVID-19among those in recovery from Opioid Use Disorder (OUD).1The study sought to identifyindividual-levelfactors associated withCOVID-19-relatedimpacts on recovery in 216 participants originally enrolled in the SUBLOCADE® (buprenorphineextended-release)clinical program.1

During September 2020 through January 2021, the study asked participants how the COVID-19 crisis affected their recovery from substance use.1Classification and Regression Tree (CART) analysis examined the association of 28 measures with self-reported impact of COVID on recovery, including demographic (e.g., race, education, employment), substance use (e.g., opioid craving/withdrawal, treatment utilization), and psycho-social factors (e.g., depression, quality of life, stress).1

The main findings from the study were as follows:

• 26% of participants reported thatCOVID-19 had made recovery somewhat or much harder1
• Past-monthopioid use rate was higher among those who reported that recovery was harder compared to those who did not (51% vs. 24%)1
• These findings suggest that a set of identified criteria in this study might be beneficial to monitor among those in recovery from OUD, particularly duringlarge-magnitude crises and particularly when access to healthcare is reduced.1

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Examining the benefit of RBP-6000 300 mg versus 100 mg maintenance dose in opioid injectors (Poster QA session) compared the efficacy and safety of SUBLOCADE 300 mg versus 100 mg maintenance doses in participants who used opioids via injection route, using the data collected during the pivotal phase 3 trial.2Adults with moderate or severe OUD were randomized to SUBLOCADE monthly injections or placebo and studied for 24 weeks.2Participants receiving SUBLOCADE were given 2 monthly injections of 300 mg, followed by 4 monthly maintenance doses of 100 mg or 300 mg over the course of the study.2

The main findings from the study were as follows:

• Opioid-injectingusers experienced continued improvement in the proportion of participants achieving abstinence with the 300 mg maintenance dose; no significant improvement was noted with the 100 mg maintenance dose2
• Higher retention rates during the maintenance dose period was observed for theopioid-injecting users who received 300 mg and for the opioid non-injecting users who received 100 mg2
• The safety profiles of 300 mg and 100 mg maintenance doses appeared comparable, including potential hepatic safety events2
• Thispost-hoc analysis suggests that although a maintenance dose of SUBLOCADE 100 mg may achieve sufficient efficacy and safety in most opioid non-injecting users, the benefit of the 300 mg maintenance dose is clinically relevant in opioid-injecting users.2

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Initiating Monthly Buprenorphine Injection After Single Dose of Sublingual Buprenorphine (Poster QA session) evaluated opioid withdrawal symptoms, safety and tolerability of initiating SUBLOCADE 300 mg one hour after administering a single dose of 4 mg transmucosal buprenorphine(BUP-TM).3During this study, 26 participants receivedBUP-TM,24 proceeded to SUBLOCADE injection, and 20 completed the study.3

The main findings from the study were as follows:

• After SUBLOCADE injection, withdrawal symptoms and opioid craving scores improved within 12h. Improvements were sustained for 4 weeks3
• Two of the 24 participants experienced precipitated withdrawal. No participants had severe withdrawal3
• No serious Treatment Emergent Adverse Events were observed, nor were any related to SUBLOCADE treatment3
• The authors concluded that initiating SUBLOCADE 300 mg following a single 4 mg dose ofBUP-TM show a safety profile similar to that observed with SUBLOCADE induction per current labeling.3

Indivior Collaborative Studies:

An Open-Label, Multicentre, Single-Arm Trial of Monthly Injections of Extended Release Buprenorphine in People With Opioid Use Disorder (Poster QA session) The CommunityLong-ActingBuprenorphine (CoLAB) study evaluated patient outcomes among people with OUD receiving 48 weeks of SUBLOCADE treatment and examined the implementation of SUBLOCADE in diverse community healthcare settings in Australia.4The primary endpoint was to assess participant retention in treatment at 48 weeks after treatment initiation.4The CoLAB study provides new insight into the uptake and experience of people with OUD and treatment service providers, with relevance for policy makers, health service planners, administrators, and practitioners.4

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Mortality of Buprenorphine and Methadone in the United States 2010-2017(Poster QA session)was conducted to provide public health surveillance of buprenorphine overdose mortality by analyzing drug mentions on death certificates from 2010 to 2017.6The study is part of a Risk Evaluation and Mitigation Strategy for SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII), SUBOXONE tablets, and SUBUTEX® tablets.6

Results indicated that the buprenorphine-involved mortality rate increased from 0.006 deaths per 100,000 population in 2010 to 0.068 in 2017.6The proportion of polysubstance involvement among buprenorphine-involved deaths rose from 76.7% in 2010 to 93.8% in 2017.6Benzodiazepines were the most frequent drug substance found with buprenorphine. Maintenance therapy is a critical tool to combating the opioid crisis, and polysubstance use further complicates treatment.6Given the high proportion of polysubstance buprenorphine-involved deaths in 2017, there is substantial need to communicate the risks of polysubstance use to patients.6

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About SUBLOCADE®7

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 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

• 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, andthrombo-embolic events, including life threatening

pulmonary emboli, if administered intravenously.

• Because of the risk of serious harm or death that could result from intravenousself-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.

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.

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About SUBOXONE®8

SUBOXONE® (BUPRENORPHINE AND NALOXONE) SUBLINGUAL FILM (CIII)

Indications and Usage

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for treatment of opioid dependence. SUBOXONE Film should be used as part of a complete treatment plan that includes counseling and psychosocial support.

IMPORTANT SAFETY INFORMATION

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

CONTRAINDICATIONS:SUBOXONE Film is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported.

WARNINGS AND PRECAUTIONS

Addiction, Abuse, and Misuse:SUBOXONE Film contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids and is subject to criminal diversion. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.

Risk of Life-Threatening Respiratory Depression and Concomitant Use of Benzodiazepines or Other CNS

Depressants with Buprenorphine:Buprenorphine has been associated with life‐threatening respiratory depression, overdose, and death, particularly when misused by self-injection or with concomitant use of benzodiazepines or other CNS depressants, including alcohol. Warn patients of the potential danger of self- administration of benzodiazepines, other CNS depressants, opioid analgesics, and alcohol while under treatment with SUBOXONE Film. Counsel patients that such medications should not be used concomitantly unless supervised by a healthcare provider.

Use with caution in patients with compromised respiratory function (e.g., chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression).

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 the time SUBOXONE Film is initiated or renewed 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, if naloxone is prescribed, how to treat with naloxone. Emphasize the importance of calling 911 or getting emergency help, even if naloxone is administered.