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Last update 12 Aug 2025

Buprenorphine

Last update 12 Aug 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

NanoBUP, Oral long-acting extended-release buprenorphine(Lyndra Therapeutics), 丁丙诺菲

+ [11]

Target

κ opioid receptor x μ opioid receptor

Action

agonists, antagonists

Mechanism

κ opioid receptor agonists(Kappa opioid receptor agonists), μ opioid receptor antagonists(Mu opioid receptor antagonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Inactive Indication

AnalgesiaCancer PainIntervertebral Disc Disease+ [9]

Originator Organization

Active Organization

+ [7]

Inactive Organization

BioDelivery Sciences International, Inc.

LTS LOHMANN Therapie-Systeme AG

Beijing Mengdi Pharmaceutical Co. Ltd.

+ [3]

License Organization

Camurus AB

Titan Pharmaceuticals, Inc.Indivior PLC

+ [4]

Drug Highest PhaseApproved

First Approval Date

United States (30 Jun 2010),

Chronic Pain

RegulationFast Track (United States), Orphan Drug (United States), Priority Review (United States)

Structure/Sequence

Molecular FormulaC29H41NO4

InChIKeyRMRJXGBAOAMLHD-IHFGGWKQSA-N

CAS Registry52485-79-7

243

Clinical Trials associated with Buprenorphine

NCT06854029

/ Not yet recruitingPhase 4IIT

Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings

The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.

Start Date01 Nov 2025

Sponsor / Collaborator

Duke University

[+4]

NCT05339256

/ Not yet recruitingPhase 2IIT

A Randomized, Controlled Trial of Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder

This study will compare in-person induction and maintenance dosing of sublingual buprenorphine to induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions and telehealth medication for opioid use disorder (MOUD).

Start Date01 Oct 2025

Sponsor / Collaborator

The New York State Psychiatric Institute

[+1]

NCT06574009

/ Not yet recruitingPhase 4IIT

Better Options for Chronic Cancer Pain: a SMART Study

This proposal is relevant to the 240,000 cancer survivors who continue to use opioids long after they have successfully completed treatment for cancer at the VHA, placing them at risk of opioid addiction and overdose, and other opioid-related problems. Yet, there are no programs at the VHA to help them find alternatives to opioids, nor evidence to inform the choice of interventions. This study will meet these needs by examining four interventions that are effective at reducing opioid use in patients with chronic musculoskeletal pain but have yet to be tested in cancer survivors on long term opioid therapy. The proposed work is relevant to the VHA Pain Office's mission to provide Veterans better pain management while limiting the risks of long-term opioid therapy and it aligns with VHA Research and Development's priority to examine clinical interventions for tapering opioids. Successful completion this project will keep VHA at the forefront of the battle against the opioid epidemic with a strategy that may be adapted to address the same needs in non-Veterans.

Start Date01 Oct 2025

Sponsor / Collaborator

VA Office of Research and Development

100 Clinical Results associated with Buprenorphine

100 Translational Medicine associated with Buprenorphine

100 Patents (Medical) associated with Buprenorphine

11,158

Literatures (Medical) associated with Buprenorphine

31 Dec 2025·ANNALS OF MEDICINE

Mindful moms: acceptability and impact of co-designed and digitally delivered video meditations for pregnant and parenting women with opioid use disorder

Article

Author: Lord, Sarah E. ; Rao, Deepika

INTRODUCTION:

Perinatal opioid use disorder (OUD) remains a public health epidemic. Stress, anxiety and depression are disproportionately high among this population and are associated with poor recovery outcomes. Mindfulness interventions show promise for supporting recovery for women. This paper reports results of a pilot study to evaluate initial efficacy and acceptability of digitally delivered mindfulness meditation videos to reduce stress and promote mindfulness among women in recovery.

METHODS:

Women with lived experience of OUD were recruited from three outpatient programs that provided care to pregnant and parenting women with a history of opioid use in rural northern New England (2 maternity care settings that offered buprenorphine as part of their service menu and 1 academic substance use treatment setting). In a pre-post study design, participants were randomly assigned to receive four of 16 short meditation videos, each delivered by email in a survey link over a 2-week period (2 per week) Videos were co-designed in earlier work with representative end-users, guided by evidence-based mindfulness interventions. Assessment included the Perceived Stress Scale and the Mindfulness Attention Awareness Scale. Participants rated each video on usefulness, enjoyability, ability to lower anxiety, and intention to use in the future. Participants also provided open-ended feedback about the videos. Data were analyzed using descriptive statistics, paired t-tests, and generalized linear modeling.

RESULTS:

A total of 20 women, ages 24-36 years, completed the pilot study. Most participants (95%) were white and non-Hispanic, reflecting the rural region. Marginal mean perceived stress scores decreased significantly from 21.49 to 19.85 [p = 0.05, d = 0.43] and mean mindfulness scores increased significantly from 3.47 to 3.76 [p = 0.04, d = 0.45]. Overall, the meditation videos were rated as highly acceptable and useful and a majority (80%) indicated intention to use the meditations in the future.

CONCLUSION:

Digitally delivered meditation videos were highly acceptable and useful to participants and the low dose intervention reduced stress and improved mindfulness. Findings inform directions for future research with larger samples to evaluate the effectiveness of this accessible digital intervention to support women in recovery and strategies for broadly implementing the intervention.

01 Dec 2025·Toxicology reports

Pharmacogenetic exploration of buprenorphine and related metabolites in umbilical cord blood

Article

Author: Monfared, Amelia ; Murrell, Derek E ; Brown, Stacy D ; Harirforoosh, Sam ; Hoang, Melissa ; Shah, Darshan S

The goal of this study was to explore associations between single-nucleotide polymorphisms (SNPs) and umbilical cord blood concentrations of buprenorphine and its metabolites following maternal administration. This is a sub-study of a prospective observational cohort investigation which included pregnant women receiving buprenorphine for opioid use disorder during pregnancy. Following delivery, umbilical cord blood samples were collected and genotyped using a pharmacogenetic panel. The drug and metabolite concentrations were analyzed through liquid chromatography-mass spectrometry, and genetic association analysis was completed using PLINK software. The included neonates (n = 14) had a mean birth weight of 3.00 ± 0.39 kg and were born to mothers receiving a mean buprenorphine dose of 10.29 ± 6.22 mg. Ten concentration groupings (drug, single metabolite, as well as drug/metabolite(s) combinations) produced 18 unique SNP associations. Two significant associations included variations in CYP3A4 and UGT1A1, which play a role in the metabolism of buprenorphine. These preliminary findings suggest potential pharmacogenetic factors influencing fetal drug exposure, warranting larger studies to validate associations and explore clinical implications for neonatal outcomes.

01 Nov 2025·INTERNATIONAL JOURNAL OF DRUG POLICY

Interpreting extended-release buprenorphine data: The importance of specifying formulations and accurately representing prior evidence

Article

Author: Lofwall, Michelle R ; Budilovsky-Kelley, Natalie R

News (Medical) associated with Buprenorphine

31 Jul 2025

·www.einpresswire.com

FDA is requiring opioid pain medicine manufacturers to update prescribing information regarding long-term use

Using its authority under Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act, FDA required extended-release/long-acting (ER/LA) opioid analgesic (OA) new drug application holders to conduct epidemiologic studies to 1) quantify the serious risks of misuse, abuse, addiction, and fatal and non-fatal overdose in patients using OAs long term and 2) assess potential risk factors for these outcomes. The studies were conducted using prespecified protocols and statistical analysis plans that were reviewed by FDA and discussed in a public scientific workshop. Studies conducted under postmarket requirements (PMRs) 3033-1 and 3033-2 were large, multisite investigations that included patients enrolled in various health insurance plans and health systems across the United States. These studies were, by design, restricted to the relatively small proportion of patients receiving OAs who go on to use them long term and therefore do not inform quantitative questions of risk related to shorter-term use of OAs. PMR 3033-1 was a prospective, observational cohort study that estimated the risks of addiction, abuse, and misuse in adult patients initiating long-term use of Schedule II OAs. Patients were recruited and data were collected from 2017 through 2021. Study participants had been enrolled in selected health insurance plans or health systems for at least one year, and either 1) filled multiple ER/LA OA prescriptions during a 90-day period (“ER/LA cohort”); or 2) filled any Schedule II OA prescriptions covering at least 70 of 90 days (“long-term opioid therapy [LtOT] cohort”). Patients who received any of the qualifying opioid analgesics (i.e., ER/LA OAs or Schedule II OAs, depending on the study cohort) in the previous six months were excluded; however, patients were not excluded for use of other prescription OA therapy. In addition, patients with an existing diagnosis of a terminal illness or opioid use disorder (OUD) in the previous 12 months, receiving methadone or buprenorphine for the treatment of OUD, or receiving hospice care were excluded. Continued OA use was not required during follow-up. After meeting the study eligibility criteria, patients were required to be free of at least one outcome at baseline and to have completed a minimum number of follow-up assessments (at least two of the three-, six-, nine-, and 12-month assessments for misuse and abuse; the 12-month assessment for OUD) to be included in one or more analyses. This resulted in 978 and 1,244 patients being included in one or more analyses for the ER/LA and LtOT cohorts, respectively. Opioid misuse was defined as the intentional use of a drug for a therapeutic purpose inappropriately outside labeling directions or in a way other than prescribed or directed by a health care professional. Opioid abuse was defined as the intentional use of a drug for a nontherapeutic purpose, repeatedly or sporadically, or for the purpose of achieving a positive psychological or physical effect. Misuse and abuse were measured using the Prescription Opioid Misuse and Abuse Questionnaire, a self-reported questionnaire validated for use in this population, which asks about symptoms in the past three months. Over 12 months, across the two cohorts, approximately 22% of included patients newly met criteria for prescription opioid misuse and approximately 9% of included patients newly met criteria for prescription opioid abuse, based on information reported at three-, six-, nine-, and 12-month assessments ( Table 1 ). Addiction was defined in this study as moderate-to-severe OUD, as assessed using a validated, semi-structured interview tool, the Psychiatric Research Interview for Substance and Mental Disorders, DSM-5, Opioid Version (PRISM-5-Op), which asks about symptoms in the past 12 months. OUD was based on a count of symptoms reported in the interview and defined in two ways: 1) using standard DSM-5 criteria, and 2) using modified criteria in which most DSM-5 symptoms were counted toward an OUD designation only when the patient indicated a non-pain reason for opioid use associated with that symptom, and the “persistent desire or attempts to quit or cut down on opioid use” criterion was counted only if multiple unsuccessful attempts were made. Over 12 months, across the two cohorts, the percentage of included patients who newly met criteria for moderate-to-severe OUD was approximately 3-6% using the standard DSM-5 criteria and approximately 1-2% using the modified DSM-5 criteria, based on information reported at the 12-month assessment ( Table 1 ). Several factors (e.g., potential volunteer bias, predominance of managed care and integrated healthcare systems) may have limited the generalizability and interpretability of findings. PMR 3033-2 was a retrospective, observational cohort study that estimated the risk of opioid-involved overdose or opioid overdose-related death (together, abbreviated as OOD) in adult patients with new long-term use of Schedule II OAs between 2006 and 2016 (n=220,249). The study included patients enrolled in either one of two commercial insurance programs, one managed care program, or one Medicaid program for at least nine months. New long-term use was defined as having Schedule II OA prescriptions 1 covering at least a 70-days’ supply over the three months before cohort entry and none during the preceding six months. Patients were excluded if they had an opioid-involved overdose in the nine months prior to cohort entry. The outcome was the first OOD event during the follow-up period, as measured using a validated medical-code-based algorithm with linkage to the National Death Index database. The cumulative incidence of OOD increased steadily throughout the five-year follow up period, resulting in a five-year cumulative incidence ranging from approximately 1.5% to approximately 4% ( Table 2 ). Over the entire study period (5-11 years, depending on study site), approximately 17% of first OOD events were fatal. There are a number of considerations when interpreting the findings from PMR 3033-2. OOD events may not have involved the prescribed OAs; rather, they could have occurred after a patient discontinued prescribed OA use and could have involved illicit opioids like heroin or fentanyl. Since the outcome for this study included only the first OOD event, a patient could have experienced subsequent events, including fatal overdose, that would not have been included in the OOD incidence estimates. Additionally, the intentionality of the OOD event (i.e., suicide vs. accidental) could not be adequately confirmed. Several factors could have contributed to bias. There was substantial attrition over the first five years of follow-up, and although this study used an incidence measure designed to account for loss to follow-up, if those who left the cohort (e.g., due to insurance disenrollment) systematically had a different risk of OOD than those remaining in the study, incidence estimates could have been biased. In addition, limiting the cohort to patients with no recent documented opioid-involved overdose likely selected patients at lower risk of OOD during follow-up. Finally, opioid overdoses that were reversed by a bystander or that otherwise did not result in either a medical claim or death were not captured. Both studies collected patient- and drug-related characteristics at baseline and conducted exploratory analyses of potential risk factors for misuse, abuse, addiction, and overdose. Many factors were associated with one or more outcomes, with one of the strongest and most consistent risk factors being a personal history of a substance use disorder. 2 In addition, higher OA dose during the three months before cohort entry was a strong and consistent risk factor for OOD. Neither study was designed to assess associations between changes in OA dose or discontinuation of opioids and adverse opioid-related outcomes. 1 Hydrocodone fixed combinations were reclassified from Schedule III to Schedule II in October 2014. Products containing hydrocodone were treated as a Schedule II opioid throughout PMR 3033-2. 2 A notable proportion of patients starting long-term OA therapy in these studies had a personal history of SUD, whether in the past year (in PMR 3033-1, 6.5% to 8% had a past-year non-opioid, non-nicotine substance use disorder, based on interview measures; in PMR 3033-2, approximately 4-6% each had OUD, alcohol use disorder, or another substance use disorder, based on diagnostic codes). PMR 3033-1 also assessed SUDs prior to the past year (29% to 34.1% had a prior-to-past-year non-opioid, non-nicotine substance use disorder, based on interview measures). Table 1. Incidence of Prescription Opioid Misuse, Prescription Opioid Abuse, and OUD in Prospective PMR 3033-1 Prescription Opioid Misuse Prescription Opioid Abuse Moderate-to-Severe OUD Pain-Adjusted DSM-5-OUD 1 DSM-5-OUD 2 ER/LA cohort 3 N 804 911 850 850 12-month incidence proportion (%, 95% CI) 22.8 (21.6, 24.0) 9.4 (7.7, 11.6) 1.4 (0.9, 2.3) 5.8 (4.5, 7.3) LtOT cohort 4 N 1,003 1,151 1,102 1,102 12-month incidence proportion (%, 95% CI) 21.6 (18.3, 25.5) 8.6 (7.4, 10.0) 1.6 (0.9, 2.9) 3.4 (2.5, 3.1) Source: Adapted from Final Study Report for Prospective PMR 3033-1. 1 Moderate-to-severe pain-adjusted DSM-5-OUD was defined as having four or more pain-adjusted DSM-5 criteria for OUD related to prescription opioid use or two or more DSM-5 criteria related to heroin use, as measured by the PRISM-5-Op. 2 Moderate-to-severe DSM-5 OUD was defined as having four or more standard DSM-5 criteria for OUD related to prescription opioid use or two or more DSM-5 criteria related to heroin use, as measured by the PRISM-5-Op. 3 Includes patients who initiated an ER/LA OA that included at least 28 days’ supply of an ER/LA OA within a 60-day window followed by a subsequent ER/LA OA prescription within a 7-day period, all within a 90-day period prior to the patient’s baseline interview. Patients could not have used an ER/LA OA in the 6 months before the initial 28 days’ supply of an ER/LA OA, but patients on IR/SA OAs during the same 6 months were still eligible for this cohort. 4 Includes patients who initiated either an ER/LA OA or a Schedule II IR/SA OA for at least 70 of the past 90 days. Patients could not have used an ER/LA OA or a Schedule II IR/SA OA in the 6 months before the initial ER/LA OA or Schedule II IR/SA OA prescription contributing to at least 70 days of use, but other prescription OA therapy would not exclude them (e.g., tramadol use). Abbreviations: CI, confidence interval; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; ER/LA, extended-release/long-acting; LtOT, long-term opioid therapy; N, number; OA, opioid analgesic; OUD, opioid use disorder; PMR, postmarketing requirement; PRISM-5-Op, Psychiatric Research Interview for Substance and Mental Disorders, DMS-5, Opioid Version Table 2. Cumulative Incidence of OOD in PMR 3033-2 HealthCore KPNW Optum VUMC N 81,782 12,009 54,515 71,932 5-year cumulative incidence (%, 95% CI) 1 1.5 (1.4, 1.6) 1.4 (1.2, 1.7) 1.5 (1.3, 1.8) 4.1 (3.9, 4.3) Source: Adapted from the Final Study Report for PMR 3033-2. 1 Five-year cumulative incidence is the complement of the Kaplan-Meier OOD-free survival preceding 5 years measured in percent (%) scale Abbreviations: CI, confidence interval; KPNW, Kaiser Permanente Northwest; N, number; OOD, opioid-involved overdose or opioid overdose-related death; PMR, postmarketing requirement; VUMC, Vanderbilt University Medical Center (Medicaid) Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical ResultPhase 2

31 Jul 2025

·www.prnewswire.com

Indivior Reports Second Quarter 2025 Financial Results and Raises FY 2025 Financial Guidance

Q2'25 Total Net Revenue of $302m; Q2'25 SUBLOCADE® Net Revenue of $209m, up 9% Year-over-Year Indivior Action Agenda Underway to Strengthen Business and Generate Operational Momentum Conference Call Scheduled for Today at 8:00 A.M. EDT RICHMOND, Va., July 31, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq: INDV) today reported its financial results for the second quarter ended June 30, 2025, and provided a business update. "SUBLOCADE® net revenue and pricing stability in SUBOXONE® Film in the U.S. drove solid results in the second quarter, leading us to raise our 2025 financial guidance," said Joe Ciaffoni, Chief Executive Officer. "In the second half of 2025, we are focused on implementing Phase 1 of the Indivior Action Agenda, Generate Momentum, which includes growing U.S. SUBLOCADE net revenue and simplifying the organization to generate operational momentum. We are committed to achieving our financial guidance for the year, investing in U.S. SUBLOCADE growth and implementing organizational changes that will strongly position us to advance to Phase 2 of the Indivior Action Agenda, Accelerate, at the start of 2026 and immediately realize bottom line accretion." "We are increasing our 2025 financial guidance to reflect better-than-expected net revenue performance in the first half of the year," said Ryan Preblick, Chief Financial Officer. "Our expectations for total net revenue and adjusted EBITDA are increasing by $65 million and $48 million, respectively, at the mid-points from our original guidance." Business Highlights Grew total SUBLOCADE Q2'25 net revenue to $209m, up 9% year-over-year and 19% versus Q1'25. Q2'25 U.S. SUBLOCADE net revenue increased 9% to $195m versus Q2'24 and 20% versus Q1'25. Growth was primarily volume driven. Initiated the Indivior Action Agenda with workstreams focused on U.S. SUBLOCADE growth and reducing organizational complexity. These efforts are expected to support long-term growth with significant operating leverage and durable cash generation. Strengthened Executive Team and Board of Directors with the addition of Patrick Barry, Chief Commercial Officer, Vanessa Procter, Executive Vice President of Corporate Affairs and Tony Kingsley, Independent Director. Completed London Stock Exchange (LSE) cancellation effective July 24, 2025. INDV now trades exclusively on Nasdaq, which aligns to the Company's capital markets footprint and a stronger focus on SUBLOCADE growth in the U.S. Announced inclusion in Russell Equity Indexes. Effective June 30, 2025, Indivior became a member of the U.S. small-cap Russell 2000® Index and the broad-market Russell 3000® Index. Presented new SUBLOCADE data at the College on Problems of Drug Dependence (CPDD) Annual Scientific Meeting demonstrating higher doses of SUBLOCADE may offer better outcomes for individuals with high levels of fentanyl use. Published study "Monthly Buprenorphine Depot Injection (SUBLOCADE) for Opioid Use Disorder During Pregnancy" in The American Journal on Addictions, illustrating monthly SUBLOCADE use as a potential treatment option for opioid use disorder during and after pregnancy. Published real-world study in Drug and Alcohol Dependence Reports that found that opioid use disorder patients treated with extended-release buprenorphine (SUBLOCADE / SUBUTEX® Prolonged Release) had 57% lower odds of all cause emergency department (ED) visits compared to those who received no medications for opioid use disorder. Introduced Adjusted EBITDA (replacing Non-GAAP Operating Income) as a new key profitability measure and financial guidance metric because management believes it to be a better measure of operating results and cash generation. See page 11 and the accompanying Q2 2025 Financial Results Presentation. Raising Financial Guidance for 2025 Raised its full-year 2025 financial guidance. Guidance assumes no material change in exchange rates for key currencies compared with 2024 average rates, notably USD/GBP and USD/EUR. Financial Results for Second Quarter Ended June 30, 2025 Total net revenue in Q2 increased 1% to $302m (Q2'24: $299m) at actual exchange rates (1% increase at constant exchange rates). Total SUBLOCADE Q2 net revenue was $209m, up 9% year-over-year and 19% versus Q1'25. U.S. net revenue in Q2 of $256m increased slightly over Q2'24. U.S. SUBLOCADE net revenue increased 9% to $195m versus Q2'24. The slight increase in U.S. net revenue was primarily driven by volume growth of SUBLOCADE offsetting the decline in SUBOXONE Film due to generic competition and the discontinuation of PERSERIS in July 2024. Rest of World net revenue in Q2 increased 5% at actual exchange rates to $46m (3% increase at constant exchange rates). Growth in SUBLOCADE / SUBUTEX® Prolonged Release and SUBOXONE Film more than offset ongoing generic erosion of the legacy SUBUTEX (buprenorphine) tablet business. Rest of World Q2 SUBLOCADE net revenue was $14m at actual exchange rates, an increase of 4% versus Q2'24. Gross margin in Q2 was 83% (Q2'24: 74%). Non-GAAP gross margin in Q2 was 84% (Q2'24: 84%). SG&A expense in Q2 was $158m (Q2'24: $152m). Non-GAAP SG&A expense in Q2 increased 6% to $146m (non-GAAP Q2'24: $137m) and primarily reflects an expected increase in marketing for U.S. SUBLOCADE. R&D expense in Q2 was $21m (Q2'24: $26m), a decrease of 20%, reflecting the refocusing of the pipeline on existing Phase 2 OUD assets (INDV-2000 and INDV-6001). Net income in Q2 was $18m and diluted EPS was $0.14 (Q2'24 net loss $97m; diluted loss per share: $(0.72)). Non-GAAP net income in Q2 was $64m and non-GAAP diluted EPS was $0.51 (Q2'24 non-GAAP net income: $66m; non-GAAP diluted EPS $0.48). The increase in non-GAAP diluted EPS reflects a lower diluted share count of approximately 8%. Adjusted EBITDA in Q2 was $88m ($93m Q2'24). The decrease primarily reflects increased marketing for U.S. SUBLOCADE. Cash and investments totaled $538m at the end of Q2'25, an increase of $191m compared to $347m at the end of 2024. Conference Call and Webcast Details A live conference call and webcast presentation will be held on July 31, 2025, at 8:00 A.M. EDT (13:00 GMT). The details to access the conference call and webcast are below. Materials will be available on the Company's website prior to the event at . The webcast link is: Participants may access the presentation telephonically by registering with the following link (please cut and paste into your browser): (Registrants will have an option to be called back directly immediately prior to the call or be provided a call-in # with a unique pin code following their registration) About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit  to learn more. Connect with Indivior on LinkedIn by visiting . Non-GAAP Financial Measures This announcement includes financial measures that are not measures defined by US GAAP, such as non-GAAP gross margin, non-GAAP selling, general and administrative expenses, non-GAAP research and development expenses, and adjusted EBITDA, non-GAAP net income and non-GAAP diluted earnings per share. These non-GAAP financial measures are not a substitute for, or superior to, results presented in accordance with US GAAP. Non-GAAP results as presented by the Company are not necessarily comparable to similarly titled measures used by other companies. As a result, these performance measures should not be considered in isolation from, or as a substitute analysis for, the Company's results as reported in accordance with US GAAP. Management performs a quantitative and qualitative assessment to determine if an item should be considered for adjustment. Non-GAAP financial measures adjust for non-recurring items and other items representing significant expenses or income that we believe do not reflect the Company's ongoing operations or the adjustment of which may help with the comparison to prior periods. Non-recurring items and other adjustments are excluded from non-GAAP financial measures consistent with the internal reporting provided to management and the Directors. Examples of such items could include share-based compensation expense, income or restructuring and related expenses from the reconfiguration of the Company's activities and/or capital structure, impairment of current and non-current assets, gains and losses from the sale of intangible assets, certain costs arising as a result of significant and non-recurring regulatory and litigation matters, and certain tax related matters. Beginning with this Q2 2025 financial release, adjusted EBITDA will replace adjusted operating income as a non-GAAP measure. The Company believes adjusted EBITDA may be useful to investors to understand the Company's performance. In addition, the Company uses "Adjusted EBITDA" in its annual incentive plan in which all executive officers participate. Supplemental historical reconciliations of net income to adjusted EBITDA for Q1 2024 to Q1 2025 are included on page 10. Share-based compensation has been excluded from non-GAAP selling, general and administrative expenses, non-GAAP net income, non-GAAP diluted earnings per share and adjusted EBITDA for the current period and prior period comparatives presented. We have not provided the forward-looking U.S. GAAP equivalents for certain forward-looking non-U.S. GAAP metrics as a result of the uncertainty and potential variability of reconciling items. Accordingly, the Company has relied upon the exception in item 10(e)(1)(i)(B) of Regulation S-K to exclude such reconciliations, as the reconciliations of these non-U.S. GAAP guidance metrics to their corresponding U.S. GAAP equivalents are not available without unreasonable effort. Columns and rows within financial tables may not foot due to rounding. Percentages and per share data have been calculated using actual, non-rounded figures. Important Cautionary Note Regarding Forward-Looking Statements This announcement contains certain statements that are forward-looking. Forward-looking statements include, among other things, express and implied statements regarding: the Company's financial guidance including net revenue, gross margin, non-GAAP gross margin, non-GAAP SG&A, non-GAAP R&D expense, and Adjusted EBITDA, and its medium- and long-term growth outlook; expected future growth and expectations for sales levels for particular products, and expectations regarding the future impact of factors that have affected sales in the past; expected operational savings and expected benefits from our reinvestment efforts; assumptions regarding expected changes in market share and expectations regarding the extent and impact of competition; assumptions regarding future exchange rates; our expectations that we can reach a final settlement related to the provision we recorded regarding opioid litigation (including the MDL) brought by certain municipalities and tribal nations and the material terms and conditions of the final settlement agreement, including the ultimate timing and structure of payments and product distribution, injunctive relief, and scope of releases; our product development pipeline and potential future products, including the timing of clinical trials, expectations regarding regulatory approval of such product candidates, the timing of such approvals, and the timing of potential commercial launch of such products or product candidates, and eventual annual revenues of such future products; company actions expected to improve or support execution, reduce organizational complexity, support long-term growth with significant operating leverage, drive durable cash generation and create value for the patients we serve and our shareholders; our belief that higher doses of SUBLOCADE may offer better outcomes for individuals with high levels of fentanyl use; and other statements containing the words "believe," "anticipate," "plan," "expect," "intend," "estimate," "forecast," "strategy," "target," "guidance," "outlook," "potential," "project," "priority," "may," "will," "should," "would," "could," "can," the negatives thereof, and variations thereon and similar expressions. 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 these forward-looking statements due to a number of factors, including: lower than expected future sales of our products; greater than expected impacts from competition; failure to achieve market acceptance of OPVEE; unanticipated costs including the effects of potential tariffs and potential retaliatory tariffs; whether we are able to identify efficiencies and fund additional investments that we expect to generate increased revenues, and the timing of such actions; and litigants with whom we are otherwise unable or unwilling to agree to final terms, or who choose to "opt out" of proposed settlements. For additional information about some of the risks and important factors that could affect our future results and financial condition, see "Risk Factors" in Indivior's Annual Report on Form 10-K filed March 3, 2025, our Form 10-Q filed May 1, 2025, and our other filings with the U.S. Securities and Exchange Commission. We have based the forward-looking statements in this report on our current expectations and beliefs concerning future events. Forward-looking statements contained in this report speak only as of the day they are made and, except as required by law, we undertake no obligation to update or revise any forward-looking statement, whether due to new information, future developments or otherwise. We define adjusted gross margin % as adjusted gross profit divided by net revenue. Indivior PLC (Amounts in millions, except per share data and percentages) (Unaudited) The 2025 YTD effective tax rate was 46% (2024 YTD: 25%). On a non-GAAP basis, the 2025 YTD effective tax rate was 18% (2024 YTD: 17%). We define Non-GAAP effective tax rate as Non-GAAP tax expense divided by Non-GAAP income before taxation. Indivior PLC (Amounts in millions, except per share data and percentages) (Unaudited) Non-GAAP diluted earnings/(loss) per share Management believes that non-GAAP diluted earnings/(loss) per share, adjusted for the impact of non-recurring items and other adjustments after the appropriate tax amount, may provide meaningful information on underlying trends to shareholders in respect of earnings per ordinary share. Weighted average shares used in computing non-GAAP diluted earnings per share are included in the table above. A reconciliation of GAAP net income to non-GAAP net income is included above. Adjusted EBITDA Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude interest expense, interest income, income tax expense or benefit, depreciation and amortization, as well as share-based compensation and other adjustments reflecting changes in our business that do not represent ongoing operations. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies. Indivior PLC (Amounts in millions, except per share data and percentages) (Unaudited) FY 2025 Original Guidance (April 24, 2025) FY 2025 Guidance now reflects the adoption of Adjusted EBITDA as a key profit measure, replacing non-GAAP Operating Income. SOURCE Indivior PLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial Statement

23 Jul 2025

·www.prnewswire.com

Indivior Real World Evidence Study Finds Medications for Opioid Use Disorder, Particularly Extended-Release Buprenorphine, Reduced Odds of Emergency Department Visits for Patients with Opioid Use Disorder

Extended-release buprenorphine (BUP-XR) had lower rates of hospitalizations, emergency department (ED) visits, and outpatient physician oﬃce visits compared to those receiving daily oral buprenorphine or no medications for opioid use disorder (MOUD) The study indicates BUP-XR may be an important tool in reducing ED visits, improving healthcare resource utilization and patient outcomes RICHMOND, Va., July 23, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV) today announced results from a new retrospective real-world study published in Drug and Alcohol Dependence Reports, which examined demographic and clinical factors associated with ED visits among adults diagnosed with opioid use disorder (OUD) over a six-month follow-up period. The study found that patients treated with BUP-XR, in the form of the once-monthly long-acting injectable formulation of buprenorphine, had 57% lower odds of all-cause ED visits compared to those who received no MOUD. Additionally, patients treated with BUP-XR experienced signiﬁcantly fewer hospitalizations and lower inpatient costs compared to those receiving daily oral buprenorphine or no MOUD. "Opioid overdose-related ED visits are a critical concern in the ongoing opioid epidemic," said Christian Heidbreder, Ph.D., Chief Scientiﬁc Oﬃcer at Indivior. "These ﬁndings underscore the clinical and economic value of long-acting injectable treatments of OUD. By reducing ED and physician oﬃce visits, BUP-XR may help ease the burden on our healthcare system while supporting long-term recovery outcomes for patients." The Indivior-funded study also revealed that patients treated with BUP-XR incurred lower inpatient healthcare costs. Inpatient costs for this group were nearly ﬁve times lower compared to patients receiving daily oral buprenorphine, and more than 10 times lower compared to patients receiving no MOUD. The BUP-XR cohort did have similar overall all-cause costs compared to the no MOUD cohort and had signiﬁcantly higher overall costs compared to the daily oral buprenorphine cohort; this was primarily driven by higher outpatient pharmacy costs in the BUP-XR cohort, although it was not possible to determine if the BUP-XR medication itself was driving the diﬀerence. Hospitalization rates for BUP-XR were similarly lower: only 3% of BUP-XR-treated patients experienced an inpatient stay during the six-month follow-up period, versus 5% of those on daily oral buprenorphine. Notably, no opioid overdose-related ED visits were recorded among patients in the BUP-XR cohort during the study period; in the daily oral buprenorphine cohort there was a 1.2% overdose rate and 1% in the no MOUD cohort. These ﬁndings are based on observed claims data and reﬂect healthcare utilization during the deﬁned study period. Although the results oﬀer valuable insights for public health oﬃcials, emergency care providers, and policymakers, the study sample may not fully represent all individuals with OUD, particularly those who are uninsured or outside traditional healthcare systems. Additionally, the six-month observation window may not capture long-term treatment engagement or relapse risk. The full study is available here: Factors associated with emergency room visits among patients with opioid use disorder: A study of buprenorphine-treated and untreated patients - ScienceDirect Disclosure: This press release has been issued by Indivior Inc. and the content has not been approved or authorized by the College on Problems of Drug Dependence. 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 . 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 is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit to learn more. Connect with Indivior on LinkedIn by visiting . SOURCE Indivior PLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical Result

100 Deals associated with Buprenorphine

External Link

KEGG	Wiki	ATC	Drug Bank
D07132	Buprenorphine	N07BC01	DB00921

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Opioid-Related Disorders	United States	Braeburn, Inc.	23 May 2023
Opium Dependence	European Union	Camurus AB	20 Nov 2018
Opium Dependence	Iceland	Camurus AB	20 Nov 2018
Opium Dependence	Liechtenstein	Camurus AB	20 Nov 2018
Opium Dependence	Norway	Camurus AB	20 Nov 2018
Opioid abuse	United States	Indivior, Inc.	30 Nov 2017
Pain	United States	Purdue Pharma LP	13 Oct 2017
Chronic Pain	United States	Purdue Pharma LP	30 Jun 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cancer Pain	Phase 3	China	LTS LOHMANN Therapie-Systeme AG	10 Jun 2019
Cancer Pain	Phase 3	China	Beijing Mengdi Pharmaceutical Co. Ltd.	10 Jun 2019
Cancer Pain	Phase 3	China	Grünenthal GmbH	10 Jun 2019
Analgesia	Phase 3	-	Purdue Pharma LP	01 Nov 2011
Pain, Postoperative	Phase 3	-	Purdue Pharma LP	01 Nov 2011
Intervertebral Disc Disease	Phase 3	China	Beijing Mengdi Pharmaceutical Co. Ltd.	01 Aug 2009
Musculoskeletal Pain	Phase 3	China	Beijing Mengdi Pharmaceutical Co. Ltd.	01 Aug 2009
opioid dependence methadone	Phase 3	United States	Titan Pharmaceuticals, Inc.	01 Sep 2008
Osteoarthritis, Spine	Phase 3	United States	Purdue Pharma LP	01 Apr 2004
Osteoarthritis, Knee	Phase 3	United States	Purdue Pharma LP	01 Jun 1999

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04454411 (CTgov)	Phase 2	Opioid abuse \| Opium Dependence	3	Brixadi (Buprenorphine)	yvsikfkrdf(eleftsblwd) = wwcayvvtgx ufgwryltpx (yjwpxwhqjn, xaozvwekhl - eontklorlz) View more	-	06 Aug 2025
				Vivitrol (Naltrexone)	yvsikfkrdf(eleftsblwd) = skppwkanzz ufgwryltpx (yjwpxwhqjn, ghzdltsiuo - jigfywplgi) View more
NCT02651584 (PRNewswire) Manual	Phase 3	Opioid-Related Disorders	123	BRIXADI (fentanyl-positive)	tjahouvyqe(fujvqrbkje) = lbcvfsrgrd ztlshvjlvg (chvoswfrku ) View more	Positive	25 Jun 2024
				buprenorphine + naloxone (fentanyl-positive)	tjahouvyqe(fujvqrbkje) = sjlvclbccv ztlshvjlvg (chvoswfrku ) View more
NCT02651584 (Pubmed)	Phase 3	fentanyl-positive \| norfentanyl	428	Subcutaneous Buprenorphine	rqvzvjqiwq(ztcouvjreu) = dqeffydwpr trlxqygyca (givvehzoin )	Positive	03 Jun 2024
				Sublingual Buprenorphine-Naloxone	rqvzvjqiwq(ztcouvjreu) = xxoibrszjk trlxqygyca (givvehzoin )
NCT02651584 (FDA) Manual	Phase 3	Opioid-Related Disorders	428	BRIXADI	iajuoniyir(pztkdqqqld) = fbrwhevlzb koqucvmkgk (pszgshzpqw ) View more	Positive	23 May 2023
				buprenorphine/naloxone	iajuoniyir(pztkdqqqld) = nxglsgkbod koqucvmkgk (pszgshzpqw ) View more
NCT02611752 (FDA) Manual	Phase 2	Opioid-Related Disorders	47	BRIXADI	hohszqrdce(kxelkortbi) = No active intramuscular hydromorphone dose resulted in a mean drug liking VAS Emax score of 11 mm or greater when compared to placebo blpuihraop (bnyjfeuamh )	Positive	23 May 2023
				Placebo
NCT03818399 (VOTIVE, CTgov)	Phase 3	Opiate Overdose \| Opioid abuse	19	SUBLOCADE	fhqaxxqded = gkyqgfplsy dkydrcubou (tvvufzqoyt, joexceijxz - lcxnhisibf) View more	-	05 May 2022
NCT03604159 (CTgov)	Phase 4	Opium Dependence	52	Buprenorphine Extended Release (Buprenorphine Extended-Release)	esvczklhln = yhzsfaxktn hrcgyopwsy (ropkqtutrf, hcjqmswmss - ethquhhoue) View more	-	11 Jan 2022
				Buprenorphine+Zubsolv (Sublingual Buprenorphine)	esvczklhln = eleiiiiwqq hrcgyopwsy (ropkqtutrf, vbcxrsfqen - xfxmbedlna) View more
NCT02891798 (CTgov)	Phase 3	Pain	98	Bupivacaine	cqrtnatmgq(afofknuppy) = pbodezbhwk ttzemjsega (nbwtrhyswp, 2.38) View more	-	20 Dec 2021
NCT02891798 (Pubmed \| Pain Med)	Phase 3	-	98	BPV-BCD	iwebwxwodq(nkirsrxpgi) = xvjnayrvdk schhmrwhbl (ghldrwfarm, 0.6 - 3.0)	-	03 Nov 2021
NCT01402492 (CURB, CTgov)	Phase 2/3	Cocaine-Related Disorders	302	Naltrexone+Buprenorphine (BUP4+XR-NTX)	alqdkhmorn(umxuaguuug) = wffxceooxj zgechqwlwp (lxyyyllvgw, 5.25) View more	-	29 Oct 2021
				Naltrexone+Buprenorphine (BUP16+XR-NTX)	alqdkhmorn(umxuaguuug) = ajjydwckbh zgechqwlwp (lxyyyllvgw, 6.77) View more

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