Indivior Announces FDA Approval of Label Changes for SUBLOCADE® (buprenorphine extended-release) Injection
Indivior (NASDAQ/LSE: INDV) announced FDA approval of significant label changes for SUBLOCADE®, their treatment for moderate to severe opioid use disorder (OUD). The key updates include a rapid initiation protocol that reduces treatment initiation time from one week to one hour, and new alternative injection sites including abdomen, thigh, buttock, and back of upper arm.
The rapid initiation protocol allows healthcare providers to start SUBLOCADE treatment after a single dose of transmucosal buprenorphine and a one-hour observation period. A non-inferiority study with 729 participants demonstrated the effectiveness of rapid initiation, with 66.4% of patients in the rapid induction arm receiving a second injection compared to 54.5% in the standard induction arm. Of the study participants, 77.5% were fentanyl-positive at induction.
These changes aim to reduce treatment obstacles and improve patient adherence while maintaining SUBLOCADE's established safety profile and efficacy.
Indivior (NASDAQ/LSE: INDV) ha annunciato l'approvazione da parte della FDA di significative modifiche all'etichetta per SUBLOCADE®, il loro trattamento per il disturbo da uso di oppioidi da moderato a grave (OUD). Le principali novità includono un protocollo di avvio rapido che riduce il tempo di inizio del trattamento da una settimana a un'ora, e nuovi siti di iniezione alternativi tra cui addome, coscia, gluteo e parte posteriore del braccio superiore.
Il protocollo di avvio rapido consente ai fornitori di assistenza sanitaria di iniziare il trattamento con SUBLOCADE dopo una singola dose di buprenorfina transmucosa e un periodo di osservazione di un'ora. Uno studio di non inferiorità con 729 partecipanti ha dimostrato l'efficacia dell'avvio rapido, con il 66,4% dei pazienti nel gruppo di induzione rapida che ha ricevuto una seconda iniezione rispetto al 54,5% nel gruppo di induzione standard. Dei partecipanti allo studio, il 77,5% era positivo al fentanyl all'induzione.
Questi cambiamenti mirano a ridurre gli ostacoli al trattamento e migliorare l'aderenza dei pazienti mantenendo il profilo di sicurezza e l'efficacia consolidati di SUBLOCADE.
Indivior (NASDAQ/LSE: INDV) anunció la aprobación de la FDA de cambios significativos en la etiqueta para SUBLOCADE®, su tratamiento para el trastorno por uso de opioides de moderado a grave (OUD). Las actualizaciones clave incluyen un protocolo de inicio rápido que reduce el tiempo de inicio del tratamiento de una semana a una hora, y nuevos sitios de inyección alternativos que incluyen abdomen, muslo, glúteo y la parte posterior del brazo superior.
El protocolo de inicio rápido permite a los proveedores de atención médica comenzar el tratamiento con SUBLOCADE después de una dosis única de buprenorfina transmucosa y un período de observación de una hora. Un estudio de no inferioridad con 729 participantes demostró la efectividad del inicio rápido, con el 66,4% de los pacientes en el grupo de inducción rápida recibiendo una segunda inyección en comparación con el 54,5% en el grupo de inducción estándar. Del total de participantes del estudio, el 77,5% dio positivo por fentanyl al inicio.
Estos cambios tienen como objetivo reducir los obstáculos al tratamiento y mejorar la adherencia de los pacientes, manteniendo el perfil de seguridad y eficacia establecidos de SUBLOCADE.
인디비어 (NASDAQ/LSE: INDV)는 중증 및 중등도 오피오이드 사용 장애(OUD) 치료제인 SUBLOCADE®의 라벨 변경에 대한 FDA 승인을 발표했습니다. 주요 업데이트에는 치료 시작 시간을 일주일에서 한 시간으로 단축하는 신속 시작 프로토콜과 복부, 허벅지, 엉덩이 및 상완 뒤쪽을 포함한 새로운 대체 주사 부위가 포함됩니다.
신속 시작 프로토콜은 의료 제공자가 단일 경구용 부프레노르핀 용량과 한 시간의 관찰 기간 후에 SUBLOCADE 치료를 시작할 수 있도록 합니다. 729명의 참가자가 포함된 비열등성 연구는 신속 시작의 효과를 입증했으며, 신속 유도 그룹의 66.4%가 표준 유도 그룹의 54.5%에 비해 두 번째 주사를 받았습니다. 연구 참가자의 77.5%는 유도 시 펜타닐 양성 반응을 보였습니다.
이러한 변화는 치료 장애를 줄이고 환자의 순응도를 개선하는 것을 목표로 하며, SUBLOCADE의 확립된 안전성 프로필과 효능을 유지합니다.
Indivior (NASDAQ/LSE: INDV) a annoncé l'approbation par la FDA de modifications significatives de l'étiquette pour SUBLOCADE®, leur traitement pour le trouble lié à l'utilisation d'opioïdes modéré à sévère (OUD). Les principales mises à jour comprennent un protocole d'initiation rapide qui réduit le temps d'initiation du traitement d'une semaine à une heure, ainsi que de nouveaux sites d'injection alternatifs, notamment l'abdomen, la cuisse, les fesses et l'arrière du bras supérieur.
Le protocole d'initiation rapide permet aux prestataires de soins de santé de commencer le traitement par SUBLOCADE après une seule dose de buprénorphine transmucosale et une période d'observation d'une heure. Une étude de non-infériorité impliquant 729 participants a démontré l'efficacité de l'initiation rapide, avec 66,4 % des patients du groupe d'induction rapide recevant une deuxième injection contre 54,5 % dans le groupe d'induction standard. Parmi les participants à l'étude, 77,5 % étaient positifs au fentanyl lors de l'induction.
Ces changements visent à réduire les obstacles au traitement et à améliorer l'adhérence des patients tout en maintenant le profil de sécurité et l'efficacité établis de SUBLOCADE.
Indivior (NASDAQ/LSE: INDV) hat die FDA-Zulassung für wesentliche Änderungen des Etiketts von SUBLOCADE®, ihrer Behandlung für mittelgradige bis schwere Opioidabhängigkeit (OUD), bekannt gegeben. Zu den wichtigsten Aktualisierungen gehört ein schnelles Initiierungsprotokoll, das die Behandlungsinitiierungszeit von einer Woche auf eine Stunde verkürzt, sowie neue alternative Injektionsstellen, darunter Bauch, Oberschenkel, Gesäß und Rückseite des Oberarms.
Das schnelle Initiierungsprotokoll ermöglicht es den Gesundheitsdienstleistern, die SUBLOCADE-Behandlung nach einer einzigen Dosis transmukosaler Buprenorphin und einer einstündigen Beobachtungszeit zu beginnen. Eine Nichtunterlegenheitsstudie mit 729 Teilnehmern zeigte die Wirksamkeit der schnellen Initiierung, wobei 66,4 % der Patienten in der Gruppe mit schneller Induktion eine zweite Injektion erhielten, verglichen mit 54,5 % in der Gruppe mit standardmäßiger Induktion. Von den Studienteilnehmern waren 77,5 % bei der Induktion fentanyl-positiv.
Diese Änderungen zielen darauf ab, Behandlungshindernisse zu verringern und die Patientenadhärenz zu verbessern, während das etablierte Sicherheitsprofil und die Wirksamkeit von SUBLOCADE erhalten bleiben.
- FDA approval of rapid initiation protocol reducing treatment time from 1 week to 1 hour
- Addition of multiple injection sites offering greater treatment flexibility
- Higher patient retention rate in rapid induction (66.4%) vs standard induction (54.5%)
- Potential for improved treatment adherence and accessibility
- None.
Insights
The FDA's approval of SUBLOCADE's label changes represents a transformative development in the OUD treatment landscape, with significant commercial implications for Indivior. The rapid initiation protocol addresses two critical barriers in OUD treatment: time-to-treatment and patient retention.
The clinical data is particularly compelling: the 66.4% retention rate for rapid induction versus 54.5% for standard induction represents a
The expansion to multiple injection sites (abdomen, thigh, buttock, and upper arm) enhances treatment flexibility and could drive adoption across diverse healthcare settings, potentially expanding SUBLOCADE's addressable market. This operational advantage could accelerate market penetration in both specialized addiction treatment centers and general medical practices.
From a competitive standpoint, these label changes create significant barriers to entry for competitors, as replicating such comprehensive clinical data would require substantial time and investment. The rapid initiation protocol, in particular, positions SUBLOCADE as a more accessible first-line treatment option, potentially capturing market share from traditional daily-dose medications.
The timing is strategically significant amid the ongoing opioid crisis, where faster treatment initiation can directly impact public health outcomes. This development could lead to increased insurance coverage and institutional adoption, driving sustainable revenue growth through improved patient acquisition and retention rates.
Rapid Initiation Protocol Reduces Time to Treatment with SUBLOCADE® From One Week to One Hour, A Significant Advancement in the Treatment of Moderate to Severe Opioid Use Disorder (OUD)
Key Label Changes Include:
- Rapid initiation Protocol: Healthcare providers can now initiate treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability.1,2
- Alternative Injection Sites: SUBLOCADE can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration2.
These FDA label changes can provide important benefits for patients and healthcare providers. Rapid initiation may lessen some of the practical obstacles to treatment induction, which may increase the likelihood that patients and providers will start therapy quickly, thereby shortening the time to achieve SUBLOCADE's therapeutic levels that provide continuous buprenorphine concentrations above 2ng/mL.3
Additionally, the ability to select a different injection site may provide patients more flexibility so that they may be inclined to continue their treatment. More options for healthcare providers to administer SUBLOCADE will streamline the course of treatment and improve integration into different healthcare environments.
"These label updates for SUBLOCADE underscore our dedication to evolving our treatment options to better serve individuals battling opioid use disorder," said Dr. Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. "These enhancements not only reflect our commitment to patient-centered care but also our ongoing efforts to align our treatments with real-world clinical needs, thereby potentially improving patient adherence and outcomes."
Indivior is committed to empowering patients on their path to recovery by providing treatments that are both effective and tailored to their medical needs. These label changes do not alter the well-established safety profile or the efficacy of SUBLOCADE and the medication continues to offer an effective treatment option for OUD while being more adaptable to patient medical needs.
The non-inferiority study supporting rapid induction with SUBLOCADE was conducted across multiple sites, included 729 participants (mean age 40.7, average opioid use of 15 years)1, and was stratified by fentanyl presence in urine screens. At induction
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.4 OUD may affect the parts of the brain that are necessary for life-sustaining functions.4
About Indivior
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD 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
References
- Data on File. Indivior Inc.
North Chesterfield, VA . - SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use [package insert]. North
Chesterfield, VA : Indivior PLC; 2025. - Jones AK, Ngaimisi E, Gopalakrishnan M, Young MA, Laffont CM. Population Pharmacokinetics of a Monthly Buprenorphine Depot Injection for the Treatment of Opioid Use Disorder: A Combined Analysis of Phase II and Phase Ill Trials. Clin Pharmacokinet. 2021;60(4):527-540. doi:10.1007/s40262-020-00957-0.
- NIDA. 2022, March 22. Drugs and the Brain. Accessed October 30,2023, from https://nida.nih.gov/publications/drugs-brains-behavior-science-addiction/drugs-brain
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SOURCE Indivior PLC
FAQ
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