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 health care providers increased flexibility in treatment administration. This may increase treatment adherence.

"These are indeed excellent flexibilities for sublocade use, and the alternative injection sites matches those of their competitor Brixadi. The rapid induction has been needed to more rapidly get patients on to the doses of buprenorphine that may be sufficient to reduce overdoses from fentanyl, because the 300 mg injection can reach sustained blood levels that have been shown to block the respiratory depression from fentanyl. In contrast, the usual sublingual doses even up to the FDA maximum of 24 mg daily appears to be insufficient to block fentanyl overdoses. Thus, many of us recommended that sublocade be given at 300 mg monthly for prevention of the lethality associated with fentanyl overdoses," Thomas R. Kosten, MD, shared exclusively with Psychiatric Times.

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.

“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.”

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