FDA Approves of Label Changes for Sublocade Injection for Opioid Use Disorder

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The US Food and Drug Administration (FDA) today authorized key modifications to the administration protocol for injectable long-acting opioid use disorder treatment buprenorphine (Sublocade). These key modifications include a rapid treatment initiation protocol and expanded alternative injection site options.¹

These label changes are posed to provide immediate benefits to both clinicians and patients. With the first key change, the rapid initiation protocol, clinicians can now initiate treatment with Sublocade following a single dose of transmucosal buprenorphine and a 1-hour observation period to confirm tolerability. This is a big shift from the previous multi-day induction process.

The second key change, alternative injection sites, allows for subcutaneous administration of Sublocade in the abdomen, thigh, buttock, or back of the upper arm. offering patients and healthcare providers increased flexibility in treatment administration. This may increase treatment adherence.

“These label updates for Sublocade underscore our dedication to evolving our treatment options to better serve individuals battling opioid use disorder,” said Christian Heidbreder, PhD, 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.”

This FDA decision came slightly delayed from the original action date of February 7.²

Supporting rapid induction with Sublocade is a noninferiority study that was conducted across multiple sites and included 729 participants (mean age 40.7, average opioid use of 15 years). The study was stratified by fentanyl presence in urine screens; at induction, 77.5% of participants were fentanyl-positive. Participants were randomized 2:1 to rapid initiation—in which participants received a single dose of 4 mg transmucosal buprenorphine (TM-BUP), followed by a SUBLOCADE injection within 1 hour—or to a standard induction—in which participants received daily TM-BUP over ≥7 days—before receiving injection 1. Rapid induction was effective; the primary endpoint of participant retention at the second injection was met. The proportion of participants who received the second injection was 66.4% in the rapid induction arm and 54.5% in the standard induction arm.

References

1. Indivior announces FDA approval of label changes for Sublocade® (buprenorphine extended-release) injection. News release. February 24, 2025. https://www.prnewswire.com/news-releases/indivior-announces-fda-approval-of-label-changes-for-sublocade-buprenorphine-extended-release-injection-302382920.html

2. Delayed FDA approval of Sublocade label changes. First Word Pharma. February 12, 2025. Accessed February 24, 2025. https://firstwordpharma.com/story/5934537