FDA Grants Priority Review to Indivior's SUBLOCADE® PAS

Indivior PLC, a notable player in the pharmaceutical industry, has announced that its Prior Approval Supplement (PAS) for SUBLOCADE® (buprenorphine extended-release) injection has received Priority Review designation by the U.S. Food and Drug Administration (FDA). The FDA has set the Prescription Drug User Fee Act (PDUFA) action date for this submission as February 7, 2025.

SUBLOCADE® is Indivior's monthly injectable formulation of buprenorphine, designed to treat moderate to severe opioid use disorder (OUD). This PAS aims to broaden treatment options through two proposed updates to the SUBLOCADE label: the inclusion of new injection sites and the implementation of a rapid induction protocol.

The first proposed update expands the current injection site from the abdomen to include the thigh, buttock, and back of the upper arm. This expansion is intended for both induction and maintenance phases of treatment. The second proposed update significantly reduces the induction period for patients by allowing for a rapid induction protocol. Instead of the current minimum of seven days on transmucosal buprenorphine (TM BUP), the new protocol proposes a single dose of TM BUP followed by a one-hour observation period to confirm tolerability. This change potentially allows for the second 300 mg dose to be administered just one week after the initial injection, depending on patient needs.

The comprehensive data included in Indivior's PAS demonstrate the efficacy and safety of the new rapid induction protocol and the pharmacokinetic profile of SUBLOCADE when injected at the alternative sites. These updates are anticipated to enhance patient experiences and broaden treatment access, particularly for those with prolonged opioid use, including fentanyl.

A Priority Review designation by the FDA means that the review process is expedited to take action within six months, compared to the standard ten months. If approved, these updates could lead to significant improvements in the treatment of OUD with SUBLOCADE.

SUBLOCADE is already indicated for the treatment of moderate to severe opioid use disorder in patients who have begun treatment with a buprenorphine-containing product and have undergone dose adjustment for at least seven days. For optimal results, SUBLOCADE should be used as part of a comprehensive treatment plan inclusive of counseling and psychosocial support.

However, there are several safety considerations and risks associated with SUBLOCADE. It carries a boxed warning due to the risk of serious harm or death with intravenous administration. SUBLOCADE forms a solid mass upon contact with body fluids, which can lead to occlusion, local tissue damage, and thrombo-embolic events. Because of these risks, SUBLOCADE is only available through a restricted program known as the SUBLOCADE REMS Program. Healthcare settings and pharmacies must be certified in this program and comply with its requirements.

Other risks include addiction, abuse, misuse, respiratory depression, sleep-related breathing disorders, serious injection site reactions, neonatal opioid withdrawal syndrome, adrenal insufficiency, and opioid withdrawal with abrupt discontinuation. It is also crucial to monitor liver function tests due to the risk of hepatitis and hepatic events. For emergent acute pain, non-opioid analgesics are recommended whenever possible.

Common adverse reactions to SUBLOCADE include constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain.

Indivior remains committed to transforming how opioid use disorder is managed and continues to innovate in this field. The company’s vision is to ensure that all patients globally have access to evidence-based treatments for substance use disorders and co-occurring conditions. Headquartered in Richmond, VA, Indivior’s products are available in over 30 countries and the company employs more than 1,000 people worldwide.