The U.S. Food and Drug Administration (FDA) has delayed its final review of proposed label changes for SUBLOCADE® (buprenorphine extended-release) Injection, as announced by Indivior PLC (Nasdaq/LSE: INDV) on February 12, 2025. The delay affects anticipated modifications that would expand the drug's administration protocols for treating opioid use disorder.
The regulatory action, originally scheduled for a Prescription Drug User Fee Act (PDUFA) date of February 7, 2025, concerns two significant proposed changes to SUBLOCADE's labeling: the implementation of a rapid initiation protocol and the addition of alternative injection sites. These modifications aim to enhance the flexibility and accessibility of the treatment regimen.
According to Indivior's statement, the FDA communicated on February 11th that while they have accepted the proposed label and found no outstanding items requiring attention, the final review process has been extended beyond the initial timeline. The specific duration of the delay has not been disclosed.
Regulatory Status and Next Steps
The company maintains active engagement with the FDA throughout this process. Indivior has committed to providing updates on the approval status of the proposed SUBLOCADE label changes as new information becomes available. The delay comes at a time when expanding treatment options and improving access to care for opioid use disorder remains a critical public health priority.
SUBLOCADE, as a long-acting buprenorphine formulation, represents an important treatment option in the ongoing effort to address the opioid crisis. The proposed label changes, once approved, could potentially improve the treatment initiation process and provide healthcare providers with more options for administration, potentially benefiting patient care and treatment adherence.
