Indivior’s SUBLOCADE® Rapid Induction and Injection Site Updates Granted FDA Priority Review
Tuesday, October 08, 2024
Indivior has announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for its Prior Approval Supplement (PAS) submission regarding SUBLOCADE® (buprenorphine extended-release) injection.
SUBLOCADE® (buprenorphine extended-release) injection is used subcutaneously to treat moderate to severe opioid use disorder in patients who have already initiated treatment with a buprenorphine-containing product and have had their dose adjusted for at least seven days. It should be used as part of a comprehensive treatment plan that includes counselling and psychosocial support.
The Prescription Drug User Fee Act (PDUFA) action date is set for 7th February 2025.
SUBLOCADE, a monthly injectable formulation of buprenorphine, is used in the treatment of moderate to severe opioid use disorder (OUD). The PAS seeks to introduce two significant updates to the SUBLOCADE label:
Alternative Injection Sites: The proposed updates would expand the current subcutaneous abdominal injection site to include the thigh, buttock, and the back of the upper arm, offering more flexibility for induction and maintenance.
Rapid Induction Protocol: The changes aim to reduce the current treatment induction period from a 7-day minimum on transmucosal buprenorphine (TM BUP) to a single dose, followed by a one-hour observation period to confirm tolerability.
Additionally, it would allow for the second 300 mg dose to be administered as early as one week after the initial injection, depending on patient needs.
Indivior's submission included data to demonstrate the safety and efficacy of the new rapid induction protocol, as well as SUBLOCADE's pharmacokinetic profile when injected at alternative sites.
These updates are expected to improve patient experience and broaden treatment access, particularly for individuals with long-term opioid use, including fentanyl.
A Priority Review designation shortens the FDA’s review time to six months, compared to the standard 10 months, potentially leading to faster access to improved OUD treatment options if approved.
Source: indivior.com
