Patients with opioid use disorder who began treatment with buprenorphine extended-release using a rapid initiation protocol were more likely to receive a second injection compared with those following the standard induction process.

The U.S. Food and Drug Administration (FDA) has approved label changes for buprenorphine extended-release (Sublocade) injection, representing a development in the management of moderate to severe opioid use disorder (OUD). Announced by Indivior PLC, the updated labeling includes a rapid initiation protocol and expanded injection site options, which may enhance flexibility in clinical practice.

The rapid initiation protocol allows health care providers to administer Sublocade after a single dose of transmucosal buprenorphine, followed by a 1-hour observation period to confirm tolerability. This modification reduces the initiation period from the previously required 1 week and may help mitigate barriers to treatment induction. Additionally, Sublocade can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering more options for both patients and providers.

The label update is supported by a noninferiority study conducted across multiple sites, which enrolled 729 participants (mean age = 40.7 years; mean opioid use duration = 15 years). At initiation, 77.5% of participants tested positive for fentanyl. Participants were randomly assigned 2:1 to either a rapid initiation group (which received a single 4-mg dose of transmucosal buprenorphine followed by Sublocade injection within 1 hour( or a standard induction group (which received daily transmucosal buprenorphine for a minimum of 7 days before injection). The primary endpoint of the study—participant retention at the second injection—was achieved by 66.4% of the rapid initiation group compared with 54.5% of the standard induction group.

The safety profile and efficacy of Sublocade remain unchanged. The product carries a risk of serious harm or death if administered intravenously, necessitating distribution through the restricted Sublocade Risk Evaluation and Mitigation Strategy program. Sublocade is indicated for the treatment of moderate to severe OUD in patients stabilized on transmucosal buprenorphine and should be used as part of a comprehensive treatment plan that includes counseling and psychosocial support. Common adverse reactions include constipation, headache, nausea, injection site pruritus, vomiting, elevated hepatic enzymes, fatigue, and injection site pain.

Reference:

Indivior PLC. Indivior announces FDA approval of label changes for SUBLOCADE® (buprenorphine extended-release) injection [press release]. Richmond, VA: Indivior PLC; February 24, 2025. Accessed February 24, 2025. https://www.indivior.com/en/media/press-releases/indivior-announces-dfa-approval-of-label-for-sublocade