FDA Approves Sublocade Label Changes

Key Label Changes Include:

Rapid initiation Protocol: Healthcare providers can now initiate treatment with Sublocade after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability.

Alternative Injection Sites: Sublocade can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration.

These FDA label changes can provide important benefits for patients and healthcare providers. Rapid initiation may lessen some of the practical obstacles to treatment induction, which may increase the likelihood that patients and providers will start therapy quickly, thereby shortening the time to achieve Sublocade’s therapeutic levels that provide continuous buprenorphine concentrations above 2ng/mL.  Additionally, the ability to select a different injection site may provide patients more flexibility so that they may be inclined to continue their treatment. More options for healthcare providers to administer Sublocade  will streamline the course of treatment and improve integration into different healthcare environments.

Indivior is committed to empowering patients on their path to recovery by providing treatments that are both effective and tailored to their medical needs. These label changes do not alter the well-established safety profile or the efficacy of Sublocade  and the medication continues to offer an effective treatment option for OUD while being more adaptable to patient medical needs.

The non-inferiority study supporting rapid induction with Sublocade was conducted across multiple sites, included 729 participants (mean age 40.7, average opioid use of 15 years), and was stratified by fentanyl presence in urine screens. At induction 77.5% of patients were fentanyl-positive. Patients were randomized at a 2:1 ratio to rapid initiation [received a single dose of 4 mg transmucosal buprenorphine (TM-BUP), followed by a Sublocade   injection within one hour] or to a standard induction (daily TM-BUP over ≥7 days) before receiving injection . Rapid induction was effective, shown by the primary endpoint of participant retention at the second injection. The proportion of participants who received the second injection was 66.4% in the rapid induction arm and 54.5% in the standard induction arm.