FDA Approves Label Changes for Indivior’s Sublocade, Enhancing Treatment Accessibility for Opioid Use Disorder

The FDA has approved label changes for Indivior's Sublocade (buprenorphine extended-release) injection16.

A new rapid initiation protocol reduces time to treatment from one week to one hour19.

Healthcare providers can now initiate Sublocade treatment after a single dose of transmucosal buprenorphine and a one-hour observation period16.

Alternative injection sites have been approved, including the abdomen, thigh, buttock, and back of the upper arm17.

These changes aim to improve treatment accessibility and flexibility for patients with moderate to severe opioid use disorder9.

The label updates do not alter Sublocade's established safety profile or efficacy1.

A non-inferiority study supporting rapid induction included 729 participants, with 66.4% retention in the rapid induction arm compared to 54.5% in the standard induction arm1.

Indivior faces market challenges, including competition from Camurus' Brixadi and changes in Medicaid coverage renewals38.

Despite these headwinds, Indivior maintains its expectation of peak Sublocade net revenue exceeding $1.5 billion8.

The company is implementing cost-saving measures, including reducing pipeline activities outside of opioid use disorder treatment5.

Sources:

1. https://www.indivior.com/en/media/press-releases/indivior-announces-fda-approval-of-label-changes-for-sublocade-injection

3. https://www.fiercepharma.com/pharma/indivior-slashes-its-revenue-projection-and-its-headcount-130

5. https://www.proactiveinvestors.com/companies/news/1059040/indivior-moves-to-shore-up-confidence-in-sublocade-1059040.html

6. https://www.nasdaq.com/articles/indivior-fda-approves-label-changes-sublocade-quick-facts

7. https://firstwordpharma.com/story/5937199

8. https://www.indivior.com/en/media/press-releases/Indivior-Provides-Preliminary-Q3-2024-Results-Updates-FY-2024-Guidance-Group-Continues-to-Expect-SUBLOCADE-Peak-Net-Revenue-of-1-5-Billion

9. https://www.patientcareonline.com/view/fda-approves-expanded-use-for-sublocade-for-opioid-use-disorder