Indivior Announces FDA Grants Priority Review For SUBLOCADE Prior Approval Supplement

(RTTNews) - Indivior Plc.(INDV) announced that the U.S. Food and Drug Administration has granted Priority Review designation for the Prior Approval Supplement of SUBLOCADE (buprenorphine extended-release) injection, which was submitted by Indivior, Inc. The Prescription Drug User Fee Act (PDUFA) action date for this submission is set for February 7, 2025.

SUBLOCADE is Indivior's monthly injectable formulation of buprenorphine for the treatment of moderate to severe opioid use disorder (OUD).

The Prior Approval Supplement (PAS) aims to expand treatment options for SUBLOCADE by proposing two key updates to its labelling. First, it introduces alternative injection sites, expanding from the current subcutaneous abdominal site to include the thigh, buttock, and back of the upper arm for both induction and maintenance treatments. Second, the PAS proposes a Rapid Induction Protocol, which reduces the induction time from the current minimum of seven days on transmucosal buprenorphine (TM BUP) to a single dose of TM BUP followed by a one-hour observation period to confirm tolerability. Additionally, it allows for the second 300 mg dose to be administered as early as one week after the initial injection, depending on the patient's needs.

A Priority Review designation means that the FDA's goal is to take action on an application within 6 months compared to 10 months under standard review and, if approved, would translate into significant improvements in opioid use disorder treatment with SUBLOCADE.

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