Indivior Statement RE: Delayed FDA Approval of SUBLOCADE® Label Changes
Indivior PLC (Nasdaq/LSE: INDV) announced that the FDA has delayed the final review of proposed label changes for SUBLOCADE® (buprenorphine extended-release) Injection. The PDUFA action date was originally scheduled for February 7, 2025. On February 11, 2025, the FDA informed Indivior that while there were no outstanding items to address following acceptance of the proposed label, the final review has been delayed. The proposed changes include rapid initiation protocol and alternative injection sites. The company will provide updates on the approval status as appropriate.
Indivior PLC (Nasdaq/LSE: INDV) ha annunciato che la FDA ha ritardato la revisione finale delle modifiche proposte all'etichetta per SUBLOCADE® (iniezione di buprenorfina a rilascio prolungato). La data di azione PDUFA era inizialmente prevista per il 7 febbraio 2025. L'11 febbraio 2025, la FDA ha informato Indivior che, sebbene non ci fossero elementi in sospeso da affrontare dopo l'accettazione dell'etichetta proposta, la revisione finale è stata posticipata. Le modifiche proposte includono un protocollo di avvio rapido e siti di iniezione alternativi. L'azienda fornirà aggiornamenti sullo stato di approvazione quando opportuno.
Indivior PLC (Nasdaq/LSE: INDV) anunció que la FDA ha retrasado la revisión final de los cambios propuestos en la etiqueta para SUBLOCADE® (inyección de buprenorfina de liberación prolongada). La fecha de acción PDUFA estaba originalmente programada para el 7 de febrero de 2025. El 11 de febrero de 2025, la FDA informó a Indivior que, aunque no había elementos pendientes después de aceptar la etiqueta propuesta, la revisión final se ha retrasado. Los cambios propuestos incluyen un protocolo de inicio rápido y sitios de inyección alternativos. La empresa proporcionará actualizaciones sobre el estado de aprobación según sea apropiado.
Indivior PLC (Nasdaq/LSE: INDV)는 FDA가 SUBLOCADE® (부프레노르핀 장시간 방출) 주사에 대한 제안된 라벨 변경의 최종 검토를 연기했다고 발표했습니다. PDUFA 행동 날짜는 원래 2025년 2월 7일로 예정되어 있었습니다. 2025년 2월 11일, FDA는 제안된 라벨이 수용된 후 해결해야 할 사항이 없었지만 최종 검토가 연기되었다고 Indivior에 통보했습니다. 제안된 변경 사항에는 빠른 시작 프로토콜과 대체 주사 부위가 포함됩니다. 회사는 적절한 경우 승인 상태에 대한 업데이트를 제공할 것입니다.
Indivior PLC (Nasdaq/LSE: INDV) a annoncé que la FDA a retardé l'examen final des modifications proposées de l'étiquette pour SUBLOCADE® (injection de buprénorphine à libération prolongée). La date d'action PDUFA était initialement prévue pour le 7 février 2025. Le 11 février 2025, la FDA a informé Indivior qu'il n'y avait aucun élément en suspens à traiter après l'acceptation de l'étiquette proposée, mais que l'examen final avait été retardé. Les modifications proposées comprennent un protocole d'initiation rapide et des sites d'injection alternatifs. L'entreprise fournira des mises à jour sur l'état d'approbation si nécessaire.
Indivior PLC (Nasdaq/LSE: INDV) gab bekannt, dass die FDA die endgültige Überprüfung der vorgeschlagenen Etikettenänderungen für SUBLOCADE® (Buprenorphin zur Injektion mit verlängerter Freisetzung) verzögert hat. Das ursprüngliche Datum für die PDUFA-Aktion war für den 7. Februar 2025 angesetzt. Am 11. Februar 2025 informierte die FDA Indivior, dass es nach der Annahme des vorgeschlagenen Etiketts keine offenen Punkte zu klären gab, die endgültige Überprüfung jedoch verzögert wurde. Zu den vorgeschlagenen Änderungen gehören ein schnelles Initiierungsprotokoll und alternative Injektionsstellen. Das Unternehmen wird bei Bedarf Updates zum Genehmigungsstatus bereitstellen.
- FDA confirmed no outstanding items to address in the proposed label
- FDA delayed final review of SUBLOCADE label changes beyond scheduled PDUFA date
- Uncertainty in timeline for label change approval
Insights
The FDA's delay in approving SUBLOCADE's label changes, while not indicating any substantive issues, carries strategic implications for Indivior's market position in the opioid use disorder treatment space. The proposed changes encompass two critical elements: rapid initiation protocol and alternative injection sites.
The rapid initiation protocol modification is particularly significant as it could substantially reduce the current requirement for patients to be clinically stable on transmucosal buprenorphine before starting SUBLOCADE. This change could accelerate patient onboarding and expand the addressable market by removing a key barrier to treatment initiation. The alternative injection sites provision would provide healthcare providers with more flexibility in administration, potentially improving patient comfort and treatment adherence.
While the delay appears administrative rather than substantive - given the FDA's confirmation of no outstanding items - it temporarily maintains the status quo in a highly competitive market where Indivior faces pressure from both branded and generic alternatives. The timing of this delay is particularly relevant as the company continues to defend its market position against emerging competitors in the extended-release buprenorphine segment.
From an operational perspective, this delay affects Indivior's ability to implement its planned market expansion strategies, which were likely timed with the expected February 7th PDUFA date. Healthcare providers and treatment centers will need to maintain current protocols until the label changes are approved, potentially impacting new patient starts and treatment center workflows.
Yesterday, February 11th, the FDA informed Indivior that, following acceptance of the proposed label for SUBLOCADE, there were no outstanding items to address, but that final review of the SUBLOCADE label changes has been delayed.
Indivior will provide further updates on the status of the approval of the proposed SUBLOCADE label changes as appropriate.
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SOURCE Indivior PLC
FAQ
What label changes are pending FDA approval for INDV's SUBLOCADE?
When was the original PDUFA date for INDV's SUBLOCADE label changes?
What did the FDA communicate to INDV about SUBLOCADE's label changes on February 11, 2025?
How will the FDA delay impact INDV's SUBLOCADE label change approval?
