FDA Approves Expanded Use of Buprenorphine Extended-Release Injection for OUD Treatment

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) approved the prior supplement submission for buprenorphine extended-release injection (SUBLOCADE) to treat opioid use disorder (OUD), announced by Indivior on February 24, 2025.¹

Back in May 2023, the FDA approved buprenorphine extended-release injection to treat moderate to severe OUD.² This decision, following the FDA granting the submission a priority review, expands the approved subcutaneous injection site of the abdomen to the thigh, buttock, and back of the upper arm for induction and maintenance.³

“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 in a statement. "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."

The updated label also reduces treatment induction time from the current 7-day minimum on transmucosal buprenorphine to a single dose of transmucosal buprenorphine with a 1-hour observation period to confirm tolerability.3 More than that, patients can receive a second 300 mg dose 1 week after the initial 300 mg injections.

Comprehensive data has demonstrated the efficacy and safety of buprenorphine extended-release injection, along with its rapid induction, at these alternate injection sites. For instance, SUBLOCADE, a randomized, double-blind, placebo-controlled phase 3 trial showed a buprenorphine 300 mg maintenance dose led to a statistically significant increase in abstinence from opioids among patients with OUD compared with the 100 mg maintenance dose.4 A prospective single-arm, multicenter, open-label trial in Australia demonstrated that buprenorphine treatment could be maintained for 96 weeks with continuous improvements in abstinence, depression, quality of life, and medication satisfaction.

As for safety, ≥ 5% of participants receiving a buprenorphine extended-release injection experienced adverse events, with the most common ones being constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain.3 Common injection site reactions include pain, erythema and pruritus with some involving abscess, ulceration, and necrosis.

References

1. Indivior Announces FDA Approval of Label Changes for SUBLOCADE® (buprenorphine extended-release) Injection. PR Newswire. February 24, 2025. https://www.prnewswire.com/news-releases/indivior-announces-fda-approval-of-label-changes-for-sublocade-buprenorphine-extended-release-injection-302382920.html. Accessed February 24, 2025.

2. Braeburn's BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder. PR Newswire. May 23, 2023. https://www.prnewswire.com/news-releases/braeburns-brixadi-buprenorphine-extended-release-subcutaneous-injection-ciii-receives-fda-approval-for-moderate-to-severe-opioid-use-disorder-301832521.html#:~:text=PLYMOUTH%20MEETING%2C%20Pa.%2C%20May,OUD)%20in%20patients%20who%20have. Accessed February 5, 2025.

3. Indivior's SUBLOCADE® Rapid Induction/Alternative Injection Site Prior Approval Supplement (PAS) Receives FDA Priority Review. Indivior. October 7, 2024. https://www.indivior.com/en/media/press-releases/Indiviors-SUBLOCADE-Rapid-Induction-Alternative-Injection-Site-Prior-Approval-Supplement-Receives-FDA-Priority-Review#:~:text=RICHMOND%2C%20Va.%2C%20Oct.,and%20Drug%20Administration%20(FDA). Accessed February 5, 2025.

4. Indivior Highlights Growing Body of Data on SUBLOCADE® (buprenorphine once-monthly extended release injection) Helping Patients Achieve Long-Term Recovery from Opioid Use Disorder during Substance Abuse Prevention Month. Indivior. October 30, 2024. https://www.indivior.com/en/media/press-releases/indivior-highlight-growing-body-of-data-on-sublocade. Accessed February 5, 2025.