Indivior Presents New Real-World Data at ASAM 2026 Annual Conference, Supporting Remission as a Treatment Outcome and Reinforcing the Clinical Benefits of Monthly Injectable Buprenorphine for Opioid Use Disorder

Rhea-AI Summary

Indivior (NASDAQ: INDV) will present two posters at ASAM 2026 (April 23-26) reporting real-world and observational findings on monthly extended-release buprenorphine (BUP-XR, SUBLOCADE).

Findings link higher MOUD coverage and BUP-XR use to lower fatal and non-fatal overdose proportions, and associate 3-month remission with better craving, withdrawal, pain, quality of life, and employment outcomes.

News Market Reaction – INDV

+0.21%

+0.21% Session close to close

In the Apr 24 session, INDV gained 0.21%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds real‑world evidence linking monthly injectable buprenorphine to lower overdos...

Analysis

This announcement adds real‑world evidence linking monthly injectable buprenorphine to lower overdose risk and positions remission—defined by DSM-5 criteria—as a meaningful treatment endpoint in OUD. Combined with prior work on cost and staffing advantages in correctional settings, it extends Indivior’s focus on both clinical and functional outcomes. Investors may watch for how such data support SUBLOCADE’s growth relative to 2025 net revenue of $1.24 billion and SUBLOCADE’s $856 million contribution.

Key Figures

Ontario OUD cohort size: more than 45,000 patients ROUTE Study participants: 443 participants ROUTE follow-up duration: up to 12 months +5 more

8 metrics

Ontario OUD cohort size more than 45,000 patients Retrospective nested case-control study of MOUD and overdose risk

ROUTE Study participants 443 participants ROUTE Study following patients within 0–3 months of starting SUBLOCADE

ROUTE follow-up duration up to 12 months Follow-up period assessing remission and treatment-relevant outcomes

Patients prescribed therapy more than 500,000 people Number prescribed Indivior’s long-acting injectable therapy for OUD

Total net revenue $1.24 billion 2025 total net revenue, up 4% year over year

SUBLOCADE net revenue $856 million 2025 SUBLOCADE net revenue, 13% growth to record level

GAAP net income $210 million Full-year 2025 GAAP net income

Adjusted EBITDA $428 million (35% margin) Full-year 2025 adjusted EBITDA and margin

Historical Context

5 past events · Latest: Apr 16 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 16	Survey on MOUD diversion	Positive	-3.1%	Survey of correctional staff highlighting support for long-acting buprenorphine to reduce diversion.
Apr 09	Earnings date notice	Neutral	+1.2%	Announcement of timing and webcast details for Q1 2026 financial results.
Mar 31	Cost impact model	Positive	+5.9%	Model suggesting SUBLOCADE can reduce staff time and related costs in corrections.
Mar 17	MOUD access survey	Negative	+1.2%	National survey highlighting limited MOUD availability and regional disparities in facilities.
Mar 12	Convertible notes offering	Negative	+0.8%	Pricing of $450M 0.625% convertible senior notes with potential additional $50M option.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent news has often been positively framed around SUBLOCADE and OUD care, but price reactions have been mixed, with several supportive updates followed by negative or muted moves.

Recent Company History

Over the last few months, INDV has repeatedly highlighted real‑world and economic benefits of its monthly injectable buprenorphine. A March 31 cost impact model and correctional‑system surveys in March–April emphasized staffing efficiencies and MOUD access, while an upsized convertible notes deal on March 12 bolstered the balance sheet. The latest ASAM 2026 data continue this theme of real‑world outcomes and remission-focused endpoints, extending the company’s narrative around SUBLOCADE’s clinical and practical advantages.

Key Terms

opioid use disorder (oud), extended-release buprenorphine, bup-xr, medications for opioid use disorder (moud), +4 more

8 terms

opioid use disorder (oud) medical

"a leader in the treatment of opioid use disorder (OUD), will present"

Opioid use disorder (OUD) is a medical condition in which a person becomes unable to control or stop using opioid drugs despite harmful consequences, often experiencing intense cravings and withdrawal symptoms. For investors, OUD matters because its prevalence and the effectiveness of treatments influence demand for related pharmaceuticals, medical services, diagnostics and public health spending; think of it like a chronic market need that can drive long-term revenue for companies offering proven solutions.

extended-release buprenorphine medical

"evidence evaluating extended-release buprenorphine, a monthly injectable commercially"

Extended-release buprenorphine is a long-acting form of a medication used to treat opioid dependence or chronic pain that releases a measured dose slowly over days or months after a single injection or implant. For investors, it matters because longer dosing can improve patient adherence and lower treatment costs, which can translate to steadier sales, regulatory scrutiny over safety and reimbursement decisions, and different competitive dynamics than short-acting products.

bup-xr medical

"monthly extended-release buprenorphine (BUP-XR) accounted for the smallest"

Bup-XR is a long-acting, injectable form of buprenorphine used to treat opioid use disorder; it delivers steady medication over weeks from a single clinic visit instead of daily pills. For investors, it matters because its longer dosing schedule can improve patient adherence, change prescribing patterns, and affect product sales, reimbursement and regulatory risks in the addiction-treatment market much like a once-a-month version of a daily prescription.

medications for opioid use disorder (moud) medical

"Of all MOUD, monthly extended-release buprenorphine (BUP-XR) accounted"

Medications for opioid use disorder (MOUD) are medicines prescribed to reduce cravings and withdrawal symptoms for people addicted to opioids, helping them stay stable and avoid relapse. For investors, MOUD matters because demand, regulatory approvals, reimbursement policies, and treatment access drive sales, affect healthcare spending and liability, and signal how companies and clinics may grow or be regulated—think of them as a proven tool that changes both patient outcomes and market dynamics.

retrospective nested case-control study medical

"This retrospective nested case-control study used Ontario administrative health"

A retrospective nested case-control study looks back through existing records within a larger group to compare people who experienced a specific outcome (cases) with similar people who did not (controls). Think of it like examining past customer files inside one club to find what differed between those who later had a problem and those who didn’t. For investors, this design can reveal safety or risk signals from real-world data quickly and cheaply, but its backwards-looking nature can leave more room for bias than a randomized study.

transmucosal buprenorphine (tm-bup) medical

"including SUBLOCADE, transmucosal buprenorphine (TM-BUP), methadone, and sustained-release"

Transmucosal buprenorphine (tm-bup) is a formulation of the opioid medication buprenorphine designed to be absorbed through the lining of the mouth (under the tongue or against the cheek) rather than swallowed. It treats opioid dependence and certain pain conditions; for investors it matters because the route of delivery affects how quickly and safely the drug works, regulatory review, patent protection, market adoption, and reimbursement — all of which influence commercial value.

dsm-5 medical

"remission (defined in this study as absence of DSM-5 symptoms except"

A standardized handbook used by clinicians to identify and categorize mental health conditions, acting like a rulebook or map that guides diagnosis and treatment decisions. Investors care because its definitions shape how many people are labeled with particular disorders, which affects demand for therapies, insurance coverage, clinical trial design and regulatory pathways—changes to the manual can therefore alter market size, reimbursement and R&D priorities.

overdose (od) medical

"smallest proportion of non-fatal and fatal OD events compared"

An overdose (OD) occurs when a person is exposed to more of a drug or chemical than their body can safely handle, producing harmful or life‑threatening effects whether accidental or intentional. For investors, ODs matter because they can trigger recalls, regulatory investigations, clinical holds, lawsuits, and lost sales — much like a major safety failure that erodes customer trust and can stall a company’s commercial and financial plans.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• A collaboration with Virginia Tech supports recognizing remission as a treatment outcome—capturing symptoms, quality of life, and functional outcomes—beyond abstinence alone
• Of all MOUD, monthly extended-release buprenorphine (BUP-XR) accounted for the smallest proportion of non-fatal and fatal OD events compared to no treatment.

RICHMOND, Va., April 24, 2026 (GLOBE NEWSWIRE) -- Indivior Pharmaceuticals, Inc. (Nasdaq: INDV), a leader in the treatment of opioid use disorder (OUD), will present one new scientific poster and collaborated with VA Tech on a second poster which will be presented at the American Society of Addiction Medicine (ASAM) Annual Conference, held April 23-26, 2026, in San Diego, California. The data add to the growing body of evidence evaluating extended-release buprenorphine, a monthly injectable commercially available as SUBLOCADE^®, in supporting meaningful outcomes for people living with OUD, including overdose-related outcomes and broader indicators associated with recovery.

“For 25 years, Indivior has been committed to advancing science that meaningfully improves care for people living with opioid use disorder,” said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. “The data presented at ASAM reinforce the importance of sustained, evidence-based treatment for enabling meaningful and lasting recovery. With more than 500,000 people prescribed Indivior’s long-acting injectable therapy, we are encouraged by continued progress in expanding access to effective care.”

Poster Highlights

1.  Impact of OAT (MOUD) in individuals with OUD who experienced an overdose in Ontario, Canada

This retrospective nested case-control study used Ontario administrative health data of more than 45,000 patients with OUD to evaluate associations between MOUD treatments, including SUBLOCADE, transmucosal buprenorphine (TM-BUP), methadone, and sustained-release oral morphine and the risk of opioid-related fatal and non-fatal overdose.

• Most overdose events occurred off treatment: Patients with higher MOUD coverage (>80% of time on MOUD) experienced less non-fatal and fatal overdose compared to those with lower MOUD coverage (<80%).
  
• Buprenorphine-based MOUD significantly reduced overdose risk: Of all MOUD, SUBLOCADE accounted for the smallest proportion of non-fatal and fatal OD events compared to no treatment. Both SUBLOCADE and TM-BUP had the lowest odds of all MOUD odds of non-fatal and fatal overdose versus no MOUD.
  

Study limitations include potential misclassification in administrative data, incomplete or inaccurate capture of opioid-related OD events and OAT use, and absence of a direct measure of OAT adherence.

2.  Associations between remission from opioid use disorder and treatment-relevant outcomes   

Provisional findings from the Remission from OUD as a Treatment Endpoint (ROUTE Study) followed 443 participants within 0-3 months of starting treatment with SUBLOCADE for up to 12 months to understand how OUD remission (defined in this study as absence of DSM-5 symptoms except craving) relates to treatment-relevant and recovery-related outcomes.

• Remission as an indicator of improved outcomes: Individuals entering the study in remission for 3-months indicated lower craving, lower withdrawal, lower pain, better quality of life, and lower rates of unemployment than those not in remission.
• Complete abstinence may neither be sufficient nor necessary: Opioid misuse and OUD remission are not always consistent; an individual may abstain from opioid misuse while not yet meeting criteria for 3-month remission, underscoring the importance of remission as a clinically meaningful treatment endpoint.

One study limitation is that participants entered at varying BUP-XR treatment durations (0-3 months), so study entry does not align with treatment initiation.

“Together, these valuable studies show that remaining on evidence-based medications can reduce the risk of overdose,” said Ann Wheeler, Vice President of Medical Affairs at Indivior. “The findings reinforce that progress in recovery extends beyond the absence of opioid use. It also includes improvements in how people feel, function, and participate in everyday life.”

About SUBLOCADE^®

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 single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

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, 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 call 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
Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE.

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.

Risk of Serious Injection Site Reactions: Likelihood may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema, and pruritus with some involving abscess, ulceration, and necrosis.

Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) 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 of 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 patients have tolerated 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. OUD may affect the parts of the brain that are necessary for life-sustaining functions.

About Indivior
As the leader in long-acting injectable treatments for opioid use disorder (OUD), Indivior is singularly focused on delivering evidence-based treatment and advancing understanding of OUD as a chronic but treatable brain disease. For more than 25 years, we have revolutionized the science of addiction medicine — developing treatments that help people move toward long-term recovery with independence and dignity. Building on this heritage, we are ushering in a new era, renewing our commitment to individuals living with OUD and carrying forward what matters most: compassion, integrity, and science. Together – with science, people living with OUD, public health champions, and communities, we are powering recovery and renewing hope. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.

Media Contact:
Cassie France-Kelly
VP, Communications
Indivior Pharmaceuticals
Indiviormediacontacts@indivior.com

Investors Contact:
Jason Thompson
VP, Investor Relations
Indivior Pharmaceuticals
+1 804 402 7123
jason.thompson@indivior.com

FAQ

What did Indivior (INDV) report at ASAM 2026 about SUBLOCADE and overdose risk?

BUP-XR (SUBLOCADE) was associated with the smallest proportion of opioid-related fatal and non-fatal overdoses among MOUD. According to Indivior, an Ontario study of over 45,000 patients found higher MOUD coverage (>80% time) linked to fewer overdose events versus lower coverage.

How does remission from OUD relate to outcomes in Indivior's ROUTE study for INDV investors?

Three-month remission correlated with lower craving, withdrawal, pain, and unemployment and higher quality of life. According to Indivior, ROUTE tracked 443 participants on SUBLOCADE up to 12 months and used remission defined as DSM-5 symptom absence except craving.

What limitations did Indivior note about the Ontario overdose study presented at ASAM (INDV)?

The study cited potential misclassification, incomplete capture of opioid-related events, and no direct adherence measure. According to Indivior, the analysis used administrative data, which may incompletely record overdose events and OAT use, affecting outcome precision.

Does Indivior (INDV) claim abstinence is required for recovery based on ASAM 2026 findings?

No; the company reported abstinence may be neither necessary nor sufficient for remission. According to Indivior, remission and opioid misuse do not always align, supporting remission as a broader, clinically meaningful treatment endpoint beyond abstinence alone.