New Study Shows Extended-Release Buprenorphine Safely Delivers Rapid, Clinically Meaningful Reductions in Opioid Use and Supports Abstinence in High-Risk Populations

Rhea-AI Summary

Indivior (Nasdaq: INDV) reported results from a randomized, double-blind trial showing monthly SUBLOCADE extended-release buprenorphine at both 100 mg and 300 mg produced rapid, clinically meaningful reductions in opioid use and improved abstinence in people with moderate-to-severe opioid use disorder.

Participants reduced opioid use from >43 instances/week at screening to <3 instances/week by week 3, a decline maintained through week 38. Post-hoc analyses found the 300-mg maintenance dose achieved significantly higher abstinence in participants with high-frequency fentanyl use. Both doses were well tolerated with no new safety signals; injection-site reactions were more common with 300 mg but were mild-to-moderate and not linked to discontinuation. The post-hoc findings were exploratory and not pre-specified.

Positive

• Opioid use fell from >43 to <3 instances/week by week 3
• Reduction in use maintained through week 38
• Both 100 mg and 300 mg doses well tolerated with no new safety signals
• 300 mg showed higher abstinence in high-frequency fentanyl users

Negative

• Injection-site reactions more common with 300 mg (mild-to-moderate)
• Key efficacy finding for 300 mg based on exploratory post-hoc analyses not pre-specified

Key Figures

Monthly dose (low) 100 mg SUBLOCADE maintenance dose in randomized double-blind trial

Monthly dose (high) 300 mg SUBLOCADE maintenance dose in randomized double-blind trial

Baseline opioid use More than 43 instances/week Opioid use at screening before treatment

Opioid use after treatment Fewer than 3 instances/week By week three on SUBLOCADE, maintained through week 38

Follow-up duration Week 38 Reduction in opioid use maintained through this time point

High-use fentanyl threshold 14 or more times/week Definition for high-frequency fentanyl subgroup

Market Reality Check

$36.43 Last Close

Volume Volume 3,409,322 is 1.41x the 20-day average of 2,410,969, indicating elevated trading interest before this publication. normal

Technical Price $35.38 is trading above the 200-day MA of $19.26, reflecting a sustained uptrend prior to the news.

Peers on Argus

Peers in specialty/generic pharma showed mixed moves (e.g., SUPN +2.2%, AMRX -2.41%, HCM -1.86%), suggesting INDV’s modest gain of 0.45% was more stock-specific than sector-driven.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 20	Legal resolution	Positive	-2.5%	Concluded DOJ matter with final <b>$295m</b> payment, ending legacy obligation.
Nov 19	Conference participation	Neutral	+1.1%	Announcement of participation and fireside chat at Piper Sandler conference.
Nov 03	Clinical evidence data	Positive	+6.2%	Real-world evidence showing SUBLOCADE adherence benefits and lower medical costs.
Oct 30	Earnings and guidance	Positive	+15.4%	Q3 beat with SUBLOCADE growth and raised FY2025 revenue and EBITDA guidance.
Oct 28	Conference participation	Neutral	+0.5%	Stifel healthcare conference participation with CEO and CFO investor meetings.

Pattern Detected

Positive, product-related and earnings news has often coincided with upward price moves, while even favorable legal resolutions have not always been rewarded.

Recent Company History

Over the last few months, Indivior has combined strategic, financial, and clinical developments. On Oct 30, 2025, it reported Q3 revenue of $314m, SUBLOCADE revenue of $219m, and raised FY2025 guidance, which saw shares rise 15.41%. A restructuring under the Indivior Action Agenda targeted at least $150m in annual savings. On Nov 3, 2025, real-world SUBLOCADE data showing clinical and economic benefits accompanied a 6.23% gain. The company then concluded a legacy DOJ matter on Nov 20, 2025, paying $295m from cash on hand, though the stock fell 2.55%. Today’s JAMA-published trial adds further evidence around extended-release buprenorphine’s impact on OUD.

Market Pulse Summary

This announcement highlights randomized, double-blind trial results showing that monthly SUBLOCADE at 100 mg and 300 mg rapidly reduced opioid use from over 43 instances per week to under 3 by week three, sustained to week 38. The data particularly support the 300 mg dose in high-frequency fentanyl users. In context, Indivior recently raised 2025 revenue guidance and showcased real-world SUBLOCADE benefits. Investors may watch for how such evidence influences prescribing trends, reimbursement decisions, and future clinical or health-economic publications.

Key Terms

extended-release buprenorphine medical

"SUBLOCADE® (extended-release buprenorphine) rapidly reduced opioid use"

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.

opioid use disorder medical

"individuals with moderate-to-severe opioid use disorder (OUD)"

Opioid use disorder is a medical condition where a person repeatedly seeks and uses opioid drugs despite harmful physical, social or mental effects, often involving strong cravings and withdrawal symptoms when stopping. It matters to investors because its prevalence, availability of effective treatments, regulatory responses, and legal or insurance costs can shift demand, revenue and risk across drug makers, treatment providers and insurers—like a widespread problem that reshapes an entire market.

post-hoc analyses medical

"Post-hoc analyses indicated the 300-mg monthly maintenance dose performed"

Post-hoc analyses are additional examinations of data done after a study or trial has finished, rather than being planned beforehand. They are like looking back through a full photo album to spot patterns you didn’t decide to check before taking the pictures: useful for generating ideas but more prone to accidental findings and bias. Investors watch for whether results rely on post-hoc analyses because such findings are less reliable and may require confirmation before affecting a company’s value.

double-blind medical

"results from a randomized, double-blind clinical trial published"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

injection-site reactions medical

"Injection-site reactions were more common in the 300-mg arm"

Injection-site reactions are local skin or tissue responses where a medication or vaccine is given by shot, commonly causing redness, pain, swelling, warmth or itching at the spot—like a temporary sore after a bee sting. For investors, how often and how severe these reactions are matters because they can affect regulatory approval, product labeling, patient acceptance, sales, and potential costs from additional studies, warnings or liability if reactions are serious or persistent.

fentanyl medical

"participants reporting high-frequency fentanyl use"

Fentanyl is a very powerful synthetic opioid used medically to treat severe pain and, in illicit form, can be deadly at much smaller doses than other painkillers. Investors pay attention because its medical use, strict regulation, growing illegal market and related legal or public‑health actions can affect drugmakers, hospitals, emergency services and broader liability or demand for treatments—similar to how a single safety issue can reshape an entire industry.

AI-generated analysis. Not financial advice.

• Both monthly maintenance doses (100 mg and 300 mg) improved opioid abstinence and were well-tolerated with no new safety signals identified.
• Post-hoc analyses indicated the 300-mg monthly maintenance dose performed significantly better than the 100-mg monthly dose in participants reporting high-frequency fentanyl use.

RICHMOND, Va., Dec. 17, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq: INDV) today announced results from a randomized, double-blind clinical trial published in JAMA Network Open. The study found that both the 100-mg and 300-mg monthly maintenance doses of SUBLOCADE® (extended-release buprenorphine) rapidly reduced opioid use and improved opioid abstinence and were well tolerated, with no new safety signals in individuals with moderate-to-severe opioid use disorder (OUD). Participants across both dose groups experienced a rapid reduction in opioid use—from more than 43 instances per week at screening to fewer than three instances per week by week three—a decline maintained through week 38.

Post-hoc analyses also identified a subset of individuals who may benefit from the higher 300-mg maintenance dose of extended-release buprenorphine. Participants who used fentanyl daily and/or 14 or more times per week had significantly higher opioid abstinence rates with 300-mg dose compared to 100 mg, suggesting a population that may potentially benefit from the higher maintenance dose regimen.

"These findings offer evidence to consider for clinicians navigating the complexities of OUD in the fentanyl era," said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. "By demonstrating that extended-release buprenorphine improves abstinence, even among those with high-frequency fentanyl use, we underscore the need for treatment approaches that adapt to the realities of today's opioid crisis and give patients the best chance at recovery."

Injection-site reactions were more common in the 300-mg arm but were mild to moderate and were not associated with discontinuation. Study limitations include the exploratory nature of the post-hoc analyses, which were not pre-specified in the trial's statistical analysis plan.

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 of 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
Indivior Pharmaceuticals works to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a human crisis to a recognized and treated chronic disease. Building on its portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.

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SOURCE Indivior PLC

FAQ

What did Indivior announce about SUBLOCADE results on December 17, 2025 for INDV?

Indivior reported a trial showing both 100 mg and 300 mg monthly SUBLOCADE rapidly reduced opioid use and improved abstinence, with benefits maintained to week 38.

How quickly did SUBLOCADE reduce opioid use in the INDV trial?

Participants went from >43 instances/week at screening to 3 instances/week by week 3, sustained through week 38.

Does the INDV study show 300 mg SUBLOCADE is better for fentanyl users?

Post-hoc analyses observed significantly higher abstinence with 300 mg versus 100 mg in participants with daily or ≥14 weekly fentanyl use.

Were there any safety concerns reported in Indivior's December 17, 2025 INDV study?

No new safety signals were identified; injection-site reactions were more common with 300 mg but were mild-to-moderate and not linked to discontinuation.

Are the 300 mg fentanyl-user findings definitive for INDV treatment guidance?

No; the finding is from exploratory post-hoc analyses that were not pre-specified and should be interpreted cautiously.

What patient population did the INDV SUBLOCADE trial study?

The trial enrolled individuals with moderate-to-severe opioid use disorder and included subgroups with high-frequency fentanyl use.