Clinical Evidence Supports Rapid SUBLOCADE® Induction as a Strategy to Improve Retention in Opioid Use Disorder Treatment
Indivior (Nasdaq: INDV) published multicenter, open-label trial results in JAMA Network Open on Oct 15, 2025 showing that rapid SUBLOCADE induction (single 4 mg oral buprenorphine followed by same-day SUBLOCADE injection) was well tolerated and produced higher retention at the second injection versus standard induction (≥7 days oral buprenorphine before first injection).
Benefits were seen across the study population and were especially pronounced among fentanyl-positive participants. Administering the second SUBLOCADE injection one week after the first was well tolerated and the safety profile up to injection two was comparable between arms. Study limitations include its open-label design, which could introduce reporting bias.
Indivior (Nasdaq: INDV) ha pubblicato risultati di uno studio multicentrico in aperto su JAMA Network Open il 15 ottobre 2025, mostrando che l'induzione rapida di SUBLOCADE (una singola dose orale di buprenorfina da 4 mg seguita dallo stesso giorno da un'iniezione di SUBLOCADE) è stata ben tollerata e ha prodotto una maggiore ritenzione alla seconda iniezione rispetto all'induzione standard (≥7 giorni di buprenorfina orale prima della prima iniezione).
I benefici sono stati osservati in tutta la popolazione dello studio e sono stati soprattutto pronunciati tra i partecipanti positivi al fentanyl. Somministrare la seconda iniezione di SUBLOCADE a una settimana dalla prima è stato ben tollerato e il profilo di sicurezza fino all'iniezione due era comparabile tra i gruppi. Tra le limitazioni dello studio vi è il suo disegno in aperto, che potrebbe introdurre bias di segnalazione.
Indivior (Nasdaq: INDV) publicó resultados de un ensayo multicéntrico, abierto, en JAMA Network Open el 15 de octubre de 2025, mostrando que la inducción rápida de SUBLOCADE (una dosis oral única de buprenorfina de 4 mg seguida, el mismo día, de la inyección de SUBLOCADE) fue bien tolerada y produjo una mayor retención en la segunda inyección frente a la inducción estándar (≥7 días de buprenorfina oral antes de la primera inyección).
Los beneficios se observaron en toda la población del estudio y fueron especialmente pronunciados entre los participantes positivos a fentanilo. Administrar la segunda inyección de SUBLOCADE una semana después de la primera fue bien tolerado y el perfil de seguridad hasta la segunda inyección fue comparable entre los brazos. Las limitaciones del estudio incluyen su diseño abierto, lo que podría introducir sesgo de reporte.
Indivior(Nasdaq: INDV)는 2025년 10월 15일 JAMA Network Open에 다기관, 공개 라벨 시험 결과를 발표했습니다. 빠른 SUBLOCADE 유도(4 mg의 단일 경구 부프노르핀 복용 후 같은 날 SUBLOCADE 주사)를 통해 내약성이 양호했고 두 번째 주사에서의 유지율이 더 높았다가 표준 유도(첫 주사 전에 경구 부프노르핀을 7일 이상 복용) 대비로 나타났습니다.
이점은 연구 인구 전체에서 관찰되었고 펜타닐 양성 참가자들 사이에서 특히 뚜렷했다고 보고됩니다. 첫 주사 후 1주일 만에 두 번째 SUBLOCADE 주사를 투여하는 것도 잘 견딜 수 있었고 두 번째 주사까지의 안전성 프로파일은 양상 간에 비슷했습니다. 연구의 한계로는 오픈 레이블 설계로 인해 보고 편향이 생길 수 있다는 점이 있습니다.
Indivior (Nasdaq: INDV) a publié des résultats d'un essai multicentrique en ouvert dans JAMA Network Open le 15 octobre 2025, montrant que l'induction rapide de SUBLOCADE (une dose orale unique de buprénorphine de 4 mg suivie, le même jour, de l'injection SUBLOCADE) a été bien tolérée et a produit un taux de rétention plus élevé lors de la deuxième injection par rapport à l'induction standard (≥7 jours de buprénorphine orale avant la première injection).
Les bénéfices ont été observés dans l'ensemble de la population de l'étude et ont été particulièrement marqués chez les participants positifs au fentanyl. L'administration de la deuxième injection SUBLOCADE une semaine après la première a été bien tolérée et le profil de sécurité jusqu'à la deuxième injection était comparable entre les bras. Les limites de l'étude incluent son caractère ouvert, ce qui pourrait introduire un biais de signalement.
Indivior (Nasdaq: INDV) veröffentlichte multicentrische, offene Studienergebnisse in JAMA Network Open am 15. Oktober 2025, die zeigen, dass die schnelle SUBLOCADE-Induktion (eine einzelne 4 mg orale Buprenorphin-Dosis gefolgt von derselben SUBLOCADE-Injektion am selben Tag) gut verträglich war und eine höhere Retention bei der zweiten Injektion im Vergleich zur Standardinduktion (≥7 Tage orales Buprenorphin vor der ersten Injektion) ergab.
Die Vorteile wurden in der gesamten Studienpopulation beobachtet und waren insbesondere ausgeprägt bei fentanyl-positiven Teilnehmern. Die Verabreichung der zweiten SUBLOCADE-Injektion eine Woche nach der ersten war gut verträglich und das Sicherheitsprofil bis zur zweiten Injektion war zwischen den Armen vergleichbar. Zu den Einschränkungen der Studie gehören ihr Open-Label-Design, das zu Berichtsverzerrungen führen könnte.
Indivior (Nasdaq: INDV) نشرت نتائج تجربة متعددة المراكز مفتوحة في JAMA Network Open في 15 أكتوبر 2025، وتظهر أن المعالجة التحفيزية السريعة لـ SUBLOCADE (جرعة فموية واحدة من Buprenorphine بقدر 4 mg تليها حقنة SUBLOCADE في اليوم نفسه) كانت متقبلة جيداً وأنتجت احتفاظاً أعلى بالحقنة الثانية مقارنة بالتحفيز القياسي (≥7 أيام من Buprenorphine فموياً قبل الحقنة الأولى).
وقد لوحظت الفوائد عبر جميع أفراد الدراسة وُجدت خصوصاً بين المشاركين الإيجابيين للفنتانيل. إعطاء الحقنة الثانية من SUBLOCADE بعد أسبوع من الأولى كان مقبولاً، وكان ملف السلامة حتى الحقنة الثانية مقارناً بين الذراعين. من القيود أن التصميم كان مفتوحاً، مما قد يعزز تحيز الإبلاغ.
Indivior（纳斯达克代码：INDV） 于 2025 年 10 月 15 日在 JAMA Network Open 发布了多中心、开放标签试验结果，显示 快速 SUBLOCADE 诱导（4 mg 口服丁丙诺啡的单次给药，随后在同日注射相同剂量的 SUBLOCADE）耐受性良好，并在 第二次注射的维持率更高，相较于标准诱导（第一针前口服丁丙诺啡≥7 天）。
收益在整个人群中均有出现，且 在芬太尼阳性参与者中尤为显著。将第二次 SUBLOCADE 注射安排在第一次后一周内的耐受性良好，直至第二次注射的安全性特征在两组之间相当。研究的局限性包括其开放标签设计，可能引入报告偏倚。
- Higher retention at second injection with rapid induction
- Effect especially pronounced in fentanyl-positive participants
- Second SUBLOCADE injection one week after first was well tolerated
- Safety profile comparable up to injection two
- Open-label design could introduce reporting bias
Insights
Rapid, same-day SUBLOCADE induction increased early retention and was well tolerated, notably among fentanyl-positive participants.
The report describes a multicenter, open-label trial published in JAMA Network Open showing that a rapid induction pathway—single 4‑mg oral buprenorphine followed by same‑day SUBLOCADE injection—yielded higher retention at the second injection than the standard ≥7‑day oral induction. The benefit appeared across the cohort and was strongest in participants testing positive for fentanyl, and the safety profile through the second injection was comparable between arms.
Key dependencies and risks rest on the trial design: it was open‑label, which can introduce reporting or performance bias despite no detected preference. The tolerability of a one‑week second injection and similar adverse event proportions to injection two were reported, but longer follow‑up and blinded assessment would better define durability and safety beyond the early induction window.
Watch near‑term measures such as broader replication or controlled trials, regulatory guidance updates, and real‑world uptake after
Rapid induction with SUBLOCADE® showed higher treatment retention rates compared to standard induction, particularly among fentanyl-positive participants
The study found that rapid induction—administration of a single dose of 4-mg oral buprenorphine followed by a same-day SUBLOCADE injection—was well tolerated and led to higher retention at the second injection compared to standard induction, which is at least seven days of oral buprenorphine dose adjustments prior to the first injection of SUBLOCADE. These benefits were observed across the full study population and were especially pronounced among fentanyl-positive participants, addressing the clinically relevant outcome that patients remain engaged with treatment after induction.
The trial also demonstrated that administering the second SUBLOCADE injection just one week after the first was well tolerated in both treatment arms as the safety profile up to injection two was comparable, reinforcing the potential for an agile and patient-centered treatment model with rapid induction. A similar proportion of participants in adverse events up to injection two.
"This study represents a pivotal advancement for both patients and clinicians confronting opioid use disorder in the fentanyl era," said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. "The demonstration that rapid, same-day induction onto SUBLOCADE is not only effective but also well tolerated is opening a critical window of opportunity to keep high-risk patients with moderate-to-severe OUD engaged in care during their most vulnerable early weeks of treatment."
Study limitations include its open-label design, which could introduce some reporting bias, although there was no evidence of patient and provider preference for either strategy.
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 ≥
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 is a pharmaceutical company working 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 (INDV) report about rapid SUBLOCADE induction on Oct 15, 2025?
How did rapid SUBLOCADE induction perform in fentanyl-positive participants in the INDV study?
Is a one-week interval between the first and second SUBLOCADE injections supported by the INDV trial?
What safety findings did Indivior (INDV) report up to injection two?
What limitation did the INDV JAMA Network Open trial acknowledge?
