The US Meals and Drug Administration (FDA) at this time licensed key modifications to the administration protocol for injectable long-acting opioid use dysfunction remedy buprenorphine (Sublocade). These key modifications embrace a fast remedy initiation protocol and expanded various injection web site choices.1
These label adjustments are posed to offer speedy advantages to each clinicians and sufferers. With the primary key change, the fast initiation protocol, clinicians can now provoke remedy with Sublocade following a single dose of transmucosal buprenorphine and a 1-hour statement interval to substantiate tolerability. This can be a massive shift from the earlier multi-day induction course of.
The second key change, various injection websites, permits for subcutaneous administration of Sublocade within the stomach, thigh, buttock, or again of the higher arm. providing sufferers and healthcare suppliers elevated flexibility in remedy administration. This will improve remedy adherence.
“These label updates for Sublocade underscore our dedication to evolving our remedy choices to raised serve people battling opioid use dysfunction,” stated Christian Heidbreder, PhD, chief scientific officer at Indivior. “These enhancements not solely mirror our dedication to patient-centered care but additionally our ongoing efforts to align our remedies with real-world medical wants, thereby doubtlessly bettering affected person adherence and outcomes.”
This FDA choice got here barely delayed from the unique motion date of February 7.2
Supporting fast induction with Sublocade is a noninferiority research that was performed throughout a number of websites and included 729 individuals (imply age 40.7, common opioid use of 15 years). The research was stratified by fentanyl presence in urine screens; at induction, 77.5% of individuals have been fentanyl-positive. Members have been randomized 2:1 to fast initiation—during which individuals acquired a single dose of 4 mg transmucosal buprenorphine (TM-BUP), adopted by a SUBLOCADE injection inside 1 hour—or to an ordinary induction—during which individuals acquired day by day TM-BUP over ≥7 days—earlier than receiving injection 1. Speedy induction was efficient; the first endpoint of participant retention on the second injection was met. The proportion of individuals who acquired the second injection was 66.4% within the fast induction arm and 54.5% in the usual induction arm.
References
1. Indivior declares FDA approval of label adjustments for Sublocade® (buprenorphine extended-release) injection. Information launch. February 24, 2025. https://www.prnewswire.com/news-releases/indivior-announces-fda-approval-of-label-changes-for-sublocade-buprenorphine-extended-release-injection-302382920.html
2. Delayed FDA approval of Sublocade label adjustments. First Phrase Pharma. February 12, 2025. Accessed February 24, 2025. https://firstwordpharma.com/story/5934537
