FDA Approves Expanded Use for Sublocade for Opioid Use Disorder

The US Food and Drug Administration (FDA) has approved updated labeling for Sublocade (buprenorphine extended-release) injection, including approval of a rapid initiation protocol that reduces the time to treatment from 1 week to 1 hour and authorization of additional injection sites, according to a Indivior news release.¹

These changes mark a significant advancement in the management of moderate to severe opioid use disorder (OUD). Under the new rapid initiation protocol, clinicians can administer Sublocade following a single 4-mg dose of transmucosal buprenorphine and a 1-hour observation period to assess tolerability. This modification contrasts with the previous requirement for at least 7 days of daily transmucosal treatment before patients could begin Sublocade therapy.¹

By shortening the induction window, health care professionals may help patients achieve therapeutic buprenorphine concentrations sooner, potentially improving treatment engagement and retention, the company said.

In addition, alternative injection sites, including the thigh, buttock, and back of the upper arm, have been approved for Sublocade administration. Previously, only subcutaneous abdominal injection was permitted. The option to choose among several anatomical sites may enhance patient comfort and adherence, while also facilitating integration of Sublocade into diverse health care settings.

"These label updates for Sublocade underscore our dedication to evolving our treatment options to better serve individuals battling opioid use disorder," said Dr. Christian Heidbreder, Ph.D., 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."¹

A recent multicenter, randomized, open-label study (N=729) provided evidence supporting the noninferiority of rapid initiation with Sublocade. Participants, 77.5% of whom were fentanyl-positive at induction, were allocated at a 2:1 ratio to either the rapid or standard (≥7 days) induction arm. The primary endpoint—retention at the second injection—was achieved by 66.4% of patients in the rapid initiation group compared with 54.5% in the standard induction group.

Indivior emphasized that these label changes do not alter the established safety profile of Sublocade. The therapy remains indicated as part of a comprehensive treatment plan that includes counseling and psychosocial support.

Reference

1. Indivior announces FDA approval of label changes for SUBLOCADE (buprenorphine extended-release) injection [news release]. PR Newswire website. Published February 24, 2025. Accessed February 24, 2025. https://prnmedia.prnewswire.com/news-releases/indivior-announces-fda-approval-of-label-changes-for-sublocade-buprenorphine-extended-release-injection-302382920.html