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# Sublocade Priority Review for Expanded Labeling
- URL: https://www.fdaweb.com/sublocade-priority-review-for-expanded-labeling/
- Published: 2024-10-07T12:00:00.000Z
- Updated: 2026-09-14T14:43:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157927

FDA has granted a priority review for an Indivior prior approval supplement for Sublocade (buprenorphine) extended-release injection for treating moderate to severe opioid use disorder (OUD). The submission is seeking approval to expand treatment options under two proposed updates to the drug’s label, including:

- Alternative Injection Sites: Expands from the current subcutaneous abdominal injection site to also include the thigh, buttock, and back of the upper arm subcutaneously for induction and maintenance.
- Rapid Induction Protocol: Reduces treatment induction time from the current seven-day minimum on transmucosal buprenorphine (TM BUP) to a single dose of TM BUP with one-hour observation period to confirm tolerability. It also allows for a second 300 mg dose to be administered as early as one week after the initial 300 mg injection, if needed.

“These updates are expected to enhance the patient experience and expand treatment access especially for those patients who, similar to the study participants, have long-term opioid use including fentanyl,” the company says.