Sublocade (buprenorphine once-monthly depot) / Indivior - LARVOL DELTA

Extended-release subcutaneous buprenorphine vs. daily sublingual buprenorphine for opioid use disorder in the emergency department. (PubMed, CJEM) - No abstract available

Journal • Addiction (Opioid and Alcohol) • Substance Abuse

Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder (clinicaltrials.gov) - P2 | N=33 | Completed | Sponsor: Frances R Levin | Suspended ➔ Completed

Trial completion • Substance Abuse

Adverse events reported to FDA adverse event reporting system for long-acting injectable buprenorphine during the first 18 months postlaunch. (PubMed, J Subst Use Addict Treat) - "FAERS AE reporting rates for BUP-SB and BUP-BX were low. The most commonly reported AEs were similar to those observed in clinical trials. These data provide insight into AE reporting patterns for long-acting injectable buprenorphine medications following their marketing authorization."

Adverse events • Journal • Addiction (Opioid and Alcohol) • Dermatology • Fatigue • Pain • Pruritus • Substance Abuse

Encephalopathy following subcutaneous administration of Brixadi® extended-release buprenorphine. (PubMed, Toxicol Rep) - "The United States Food and Drug Administration has approved two brands for monthly injection, Sublocade ® (Indivior, North Chesterfield, VA, USA) and Brixadi® (Braeburn, Plymouth Meeting, PA, USA)...A 62-year-old patient with a history of current methamphetamine and prior fentanyl abuse, chronic pain due to lumbar radiculopathy presented to the emergency department with three days of altered mental status...Urine fentanyl testing on the date of presentation was negative. She developed persistent altered mentation and somnolence starting two hours after injection."

Journal • Addiction (Opioid and Alcohol) • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain • Psychiatry • Substance Abuse

Assessing Optimal XRB Initiation Points in Jail (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: NYU Langone Health | N=200 ➔ 50

Enrollment change • Substance Abuse

Reconsidering the usefulness of using long-acting injectable buprenorphine as a tapering tool: a case report of delayed withdrawal months after last dose. (PubMed, Front Psychiatry) - "Administration of 12.5 mg naltrexone precipitated a clinically significant worsening of withdrawal, supporting ongoing μ-opioid receptor agonism at month four. Comprehensive tapering protocols, extended monitoring (6-12 months), reinforcement of recovery capital (defined as the sum of internal and external resources that support sustained recovery), and explicit informed consent about delayed withdrawal are essential when considering LAIB to discontinue buprenorphine. Clinicians should anticipate the need for bridging strategies, including symptomatic agents (such as clonidine or gabapentin), or buprenorphine rescue (temporary or return to maintenance)-and weigh formulation differences (Sublocade vs Brixadi) when planning stepwise tapers."

Journal • CNS Disorders • Mental Retardation • Psychiatry • Substance Abuse

An in vivo Study on Extended-Release Formulation of Buprenorphine in Sprague-Dawley Rats. (PubMed, Drug Dev Ind Pharm) - "In this study, we aimed to evaluate the in vivo performance of an extended-release subcutaneous injection formulation of buprenorphine.MethodsThe extended-release formulation of buprenorphine was developed by Nano Daru Pharmaceutical Company to exhibit in vivo characteristics comparable to Sublocade®...The plasma concentration-time profile of the formulation showed an initial peak on Day 1 post-administration; buprenorphine levels then declined gradually, reaching their lowest concentration on Day 3. Subsequently, the concentration increased, reached a secondary peak, and then declined slowly thereafter.ConclusionAccording to the results, the plasma buprenorphine concentrations indicate sustained delivery of buprenorphine over a one-month period."

Journal • Preclinical • Pain

Contingency management for adherence to injectable medication for substance use disorders. (PubMed, J Subst Use Addict Treat) - "CM approaches are a key strategy for improving adherence to life-saving medications for substance use disorders. In this retrospective cohort study, CM implementation was associated with significantly higher rates of medication adherence compared to a cohort who received treatment prior to CM being available. The CM adaptations implemented by the clinic for this naturalistic study may hold promise for future efforts to reduce administrative burdens of CM without sacrificing effectiveness."

Journal • Addiction (Opioid and Alcohol)

Preparedness and Perceptions: Third-year Medical Students' Understanding of Harm Reduction and Medication for Opioid Use Disorder (APA 2026) - "Harm reduction offers a pragmatic, evidence-based approach to mitigating adverse outcomes associated with opioid use disorder (OUD), including strategies such as naloxone distribution, fentanyl test kits, syringe exchange programs, "Never Use Alone" hotlines, and medication for opioid use disorder (MOUD)...96%, 87%, 59%, and 54% of respondents (n=101) were familiar with methadone, naltrexone, suboxone, and extended-release buprenorphine (e.g. Brixadi, Sublocade), respectively... Results showed that 80% of respondents (n=104) had clinical exposure to patients with OUD. 13.6% of respondents (n=104) felt adequately prepared to treat OUD patients. 96%, 87%, 59%, and 54% of respondents (n=101) were familiar with methadone, naltrexone, suboxone, and extended-release buprenorphine (e.g."

Addiction (Opioid and Alcohol) • Human Immunodeficiency Virus • Infectious Disease • Substance Abuse

Injectable Buprenorphine in Prison: A Preference Trial (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: Lifespan | Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

Assessing impact of buprenorphine for opioid use disorder on infectious disease management. (PubMed, J Subst Use Addict Treat) - "Patients on BUP-XR showed a reduction in the incidence of bacteremia and overall HCRU relative to those on TM-BUP."

Journal • Addiction (Opioid and Alcohol) • Hepatitis B • Infectious Disease • Inflammation • Substance Abuse

Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial (clinicaltrials.gov) - P4 | N=12 | Recruiting | Sponsor: Pouya Azar | Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

Clarifying the evidence and implications of prioritizing extended-release buprenorphine for opioid agonist treatment in Canada's federal correctional system. (PubMed, Can J Public Health) - "Correctional Service Canada (CSC) recently revised its opioid agonist treatment (OAT) policy, designating extended-release injectable buprenorphine (XR-BUP; Sublocade) as the first-line treatment for opioid use disorder (OUD) in Canadian federal corrections. Methadone is now a second-line option, and buprenorphine/naloxone is no longer available, raising concerns regarding access, clinical autonomy, and equivalence of care...Restricting access to evidence-based OAT options among correctional populations risks undermining patient-centered care, continuity of treatment, and alignment with general clinical guidelines. Ideally, XR-BUP should be offered as a valuable addition, while preserving access to the full range of evidence-based OAT options."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

Association between extended-release buprenorphine adherence and reduced healthcare costs among insured patients with opioid use disorder. (PubMed, Front Public Health) - "To evaluate the relationship between adherence to extended-release buprenorphine (BUP-XR; SUBLOCADE®) and reduced healthcare utilization and medical costs among patients with opioid use disorder (OUD)...The lower adjusted costs observed in Groups 3 and 4 reflected patient disengagement from care, characterized by substantially fewer outpatient services and higher acute care utilization. Sustained BUP-XR adherence reduced costly medical utilization compared to non-adherence to BUP-XR while maintaining adherence to overall MOUD."

HEOR • Journal • Retrospective data • Addiction (Opioid and Alcohol) • Substance Abuse

INDV-6001 Multiple-Dose Pharmacokinetic Study (clinicaltrials.gov) - P2 | N=123 | Completed | Sponsor: Indivior Inc. | Active, not recruiting ➔ Completed

Trial completion • Substance Abuse

COPILOT: Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: University of California, San Francisco

New P4 trial • Substance Abuse

Case Series: Simultaneous Use of Long-Acting Injectable Antipsychotics and Vivitrol or Long-Acting Buprenorphine in Dual Diagnosis Patients with Bipolar Disorder and Substance Use Disorders. (PubMed, Psychopharmacol Bull) - "Medication combinations included paliperidone palmitate with Sublocade (n = 2) and aripiprazole lauroxil with Sublocade (n = 1). This combination approach may be particularly valuable for patients with poor medication adherence. Preliminary findings support the need for controlled research to establish optimal patient selection criteria, medication combinations, and predictors of treatment response."

Journal • Retrospective data • Addiction (Opioid and Alcohol) • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

A systematic approach to develop and characterize a compositionally equivalent buprenorphine in situ forming implant (Sublocade®). (PubMed, J Control Release) - "Sublocade® and reverse-engineered BUP-ISFI had similar in vitro drug release profiles and demonstrated similar pharmacokinetic profile and drug absorption. This study provides valuable insights into PLGA purification, characterization and in vitro/in vivo evaluation of solution-based in situ forming implants, which is essential for the development of generic products."

Journal • Substance Abuse

Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial (clinicaltrials.gov) - P4 | N=12 | Not yet recruiting | Sponsor: Pouya Azar

New P4 trial • Substance Abuse

CHOICE: Combined Injectable Treatment for HIV and OUD (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Rhode Island Hospital | N=40 ➔ 0 | Active, not recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Human Immunodeficiency Virus • Infectious Disease • Substance Abuse

CHOICE: Combined Injectable Treatment for HIV and OUD (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Rhode Island Hospital | Recruiting ➔ Active, not recruiting | Phase classification: P1 ➔ P2 | Trial completion date: Oct 2024 ➔ Feb 2026 | Trial primary completion date: Apr 2024 ➔ Aug 2025

Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Substance Abuse

SUBLOCADE Long-term Outcomes (clinicaltrials.gov) - P=N/A | N=480 | Completed | Sponsor: Indivior Inc. | Active, not recruiting ➔ Completed | N=1200 ➔ 480

Enrollment change • Trial completion • Addiction (Opioid and Alcohol) • Substance Abuse

Sublocade(Buprenorphine)DepotContributingtoAcuteHypoxicRespiratoryFailure (ASA 2025) - "A 32 year old male with a past medical history significant for opiate and methamphetamine use presented with acute hypoxic respiratory failure following administration of 300mg of sublocade he subsequently developed nausea, vomiting, difficulty urinating and shortness of breath. The sublocade depot was removed surgically with immediate improvement in urinary retention and hypoxic repiratory failure. This case demonstrates the risks of sublocade injections in patient with concomitant respiratory disease."

Cardiovascular • Infectious Disease • Pneumonia • Respiratory Diseases • Ventricular Tachycardia

INDV-6001 Multiple-Dose Pharmacokinetic Study (clinicaltrials.gov) - P2 | N=122 | Active, not recruiting | Sponsor: Indivior Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Substance Abuse

Monitoring and management of injection site reactions in patients receiving subcutaneous buprenorphine (Sublocade): two case reports and literature review. (PubMed, J Addict Dis) - "The first case was managed conservatively with cold compresses, topical hydrocortisone, and ibuprofen, resulting in symptom resolution. While ISRs associated with Sublocade are common, most are manageable with conservative interventions. Emphasizing patient education, proper injection techniques, and site rotation is essential to prevent ISRs, minimize their severity, and enhance treatment outcomes in patients with OUD."

Journal • Dermatology • Pain • Substance Abuse