Rapid initiation with Sublocade improves retention for opioid use disorder treatment

New data show that rapid initiation with once-monthly Sublocade significantly improved treatment retention vs. standard initiation among patients with opioid use disorder, according to a press release.

As Healio previously reported, in 2017 the FDA approved Sublocade (Indivior), a once-monthly extended-release buprenorphine injection, for the treatment of moderate to severe opioid use disorder among adults who have begun treatment with a product containing transmucosal buprenorphine and have been on a stable dose for at least 7 days.

The multicenter, randomized, open-label sub-study, presented at the Canadian Society of Addiction Medicine 2024 Scientific Conference in Hamilton, Ontario, included 729 participants (mean age, 42 years; mean opioid use, 15 years) who were randomly assigned 2:1 to rapid initiation (a single dose of 4 mg transmucosal buprenorphine) or standard initiation ( 7 days of transmucosal buprenorphine) before the first extended-release buprenorphine injection.

Researchers stratified randomization by fentanyl presence in same-day urine drug screens; the fentanyl-positive rate was 78%, according to researchers.

The primary endpoint of the study was retention rate difference at the second injection, which was administered 1 week after the first injection.

Researchers observed that rapid initiation was superior to standard initiation by the second injection, with an 11.8% overall improvement in retention rates and a 14.8% improvement among the fentanyl-positive group. Researchers calculated posterior probabilities showing that rapid initiation was 99.9% superior than standard initiation for the overall population and 100% superior for the fentanyl-positive group.

There were no individual adverse events with 5% or greater incidence, results showed.

“These findings underscore the potential for rapid initiation to transform opioid use disorder treatment,” Christian Heidbreder, PhD, chief scientific officer at Indivior, said in the release. “Rapid initiation may improve patient retention and meet the immediate needs brought on by synthetic opioids in real-world settings, offering a practicable path to stabilization and long-lasting, meaningful recovery.”

According to the release, the FDA has granted priority review designation to Sublocade for a labeling supplement, which would expand the label to include rapid initiation 1 hour after a single dose of transmucosal buprenorphine. Additionally, it would expand the subcutaneous administration of Sublocade to alternative injection sites, including the thigh, upper arm and buttocks.

Reference:

• Shiwach R, et al. A randomized open-label study comparing rapid and standard inductions to injectable buprenorphine extended-release (BUP-XR) treatment. Presented at: Canadian Society of Addiction Medicine Scientific Conference; Nov. 14-16, 2024; Hamilton, Ontario, Canada.