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Indivior's Game-Changing FDA Label Updates for SUBLOCADE

Indivior PLC, a prominent player in addiction treatment, has made significant strides with its medication SUBLOCADE® (buprenorphine extended-release), gaining the green light from the U.S. Food and Drug Administration (FDA) for crucial label changes. These updates, which include a rapid initiation protocol and new flexible injection site options, represent a major advancement in managing moderate to severe opioid use disorder (OUD).

Key Changes in SUBLOCADE’s FDA Label

The latest modifications to SUBLOCADE's label are expected to enhance the treatment experience for both healthcare providers and patients facing opioid dependency. These key changes include:

1. Rapid Initiation Protocol: Healthcare practitioners can now commence treatment with SUBLOCADE after administering a single dose of transmucosal buprenorphine followed by just one hour of observation to ensure tolerability. This protocol significantly reduces the waiting period for patients seeking treatment, making access to care more immediate.

2. Alternative Injection Sites: With the newly approved protocol, SUBLOCADE can be injected subcutaneously in various locations including the abdomen, thigh, buttock, and back of the upper arm. This increased flexibility helps improve the treatment administration process, accommodating patients' preferences and enhancing comfort.

These adjustments not only mitigate the barriers to treatment initiation but also aim to promote quicker achievement of therapeutic levels of SUBLOCADE, which can maintain steady buprenorphine concentrations above 2ng/mL—critical for patient's recovery progression.

Enhancing Patient Care

Dr. Christian Heidbreder, Ph.D., Indivior’s Chief Scientific Officer, emphasized the commitment to evolving treatment options to better cater to the needs of those suffering from OUD.