Indivior PLC(INDV) Prnewswire·2025-02-24 07:00Core Insights - The FDA has approved label changes for SUBLOCADE®, introducing a rapid initiation protocol and alternative injection sites, which represents a significant advancement in treating moderate to severe opioid use disorder (OUD) [1][2][3] Summary by Sections Label Changes - The new rapid initiation protocol allows healthcare providers to start treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability [6] - Alternative injection sites now include the abdomen, thigh, buttock, or back of the upper arm, providing increased flexibility for patients and healthcare providers [6] Clinical Study - A non-inferiority study involving 729 participants demonstrated the effectiveness of rapid induction, with 66.4% of participants in the rapid induction arm receiving the second injection compared to 54.5% in the standard induction arm [4] Commitment to Patient Care - The company emphasizes its dedication to evolving treatment options for individuals with OUD, aiming to improve patient adherence and outcomes through these label changes [3][16] - SUBLOCADE continues to maintain its established safety profile and efficacy while being more adaptable to patient needs [3] Company Overview - Indivior is a global pharmaceutical company focused on developing medicines for substance use disorders, with a vision of providing evidence-based treatment for chronic conditions related to substance use [16]