FDA Grants Priority Review for Indivior's SUBLOCADE® Expansion

Key Insights

• The FDA granted Priority Review to Indivior's sNDA for SUBLOCADE®, setting a PDUFA date of February 7, 2025.
• The sNDA seeks approval for alternative injection sites (thigh, buttock, back of the arm) for both induction and maintenance.
• The submission includes a rapid induction protocol, reducing induction time to one hour after a single transmucosal buprenorphine dose.

Indivior PLC announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation to its Prior Approval Supplement (PAS) for SUBLOCADE® (buprenorphine extended-release) injection. The Prescription Drug User Fee Act (PDUFA) action date is set for February 7, 2025.

SUBLOCADE, a monthly injectable formulation of buprenorphine, is used for treating moderate to severe opioid use disorder (OUD). The PAS aims to broaden treatment options with two proposed label updates: alternative injection sites and a rapid induction protocol.

Alternative Injection Sites

The proposed label expansion includes alternative subcutaneous injection sites in the thigh, buttock, and back of the upper arm for both induction and maintenance. Currently, SUBLOCADE is only approved for subcutaneous abdominal injection.

Rapid Induction Protocol

The PAS also seeks approval for a rapid induction protocol. This protocol reduces the treatment induction time from the current minimum of 7 days on transmucosal buprenorphine (TM BUP) to a single dose of TM BUP with a one-hour observation period to confirm tolerability. Furthermore, it allows for the second 300 mg dose to be administered as early as one week after the initial 300 mg injection, based on patient needs.

Indivior's submission included data demonstrating the efficacy and safety of the new rapid induction protocol and SUBLOCADE's pharmacokinetic profile following injection at alternative sites. The company believes these updates will enhance the patient experience and expand treatment access, particularly for patients with long-term opioid use, including fentanyl.

A Priority Review designation means the FDA aims to take action on the application within 6 months, compared to the standard 10 months. If approved, these changes could lead to significant improvements in OUD treatment with SUBLOCADE.

SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days. It should be used as part of a complete treatment plan that includes counseling and psychosocial support.