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FDA OKs Label Changes for Buprenorphine Injections, Reducing Time to Treatment in Opioid Use Disorder
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Key Takeaways
- FDA-approved label changes for buprenorphine extended-release include alternative injection sites and a rapid initiation protocol, enhancing treatment flexibility for OUD patients.
- Rapid initiation protocol reduces time to treatment initiation, involving a single buprenorphine dose and a 1-hour observation period, expediting therapeutic level achievement.
The label changes to buprenorphine extended-release injections can increase convenience and adherence for patients with moderate to severe opioid use disorder.
The FDA has approved label changes for buprenorphine extended-release (Sublocade; Indivior PLC) injection, including alternative injection sites and a rapid initiation protocol, which stand as a major achievement in the treatment of patients with moderate to severe opioid use disorder (OUD), according to a news release from Indivior.1
Buprenorphine injections help patients treat their opioid addiction. | Image Credit: © ankreative - stock.adobe.com
Buprenorphine’s rapid initiation protocol allows treatment providers to begin treatment with the therapy following a single dose of buprenorphine and a 1-hour observation period to confirm patient tolerability, a major reduction in time to treatment initiation from the 1-week benchmark indicated prior. Furthermore, the label changes indicate that buprenorphine may be administered subcutaneously in the thigh, abdomen, buttock, or back of the upper arm, which provides expanded flexibility when administering the therapy.1
Investigators have found that, with these label changes, significant benefits can be gained for providers and patients alike. The addition of rapid initiation reduces some of the burdens associated with treatment induction and could make patients and providers more motivated to initiate therapy quickly. As a result, there would be a shortened time to achieve the therapeutic levels of buprenorphine extended release that provides sustained buprenorphine concentrations above 2 ng/mL, allowing for more optimized treatment for patients with OUD.1,2
Additionally, having options for alternative injection sites provides further flexibility for patients who may have difficulty tolerating their injections in other areas. Patients could be more inclined to continue their treatment due to the greater convenience offered by the label changes, according to investigators. These benefits extend to health care providers, as more choices “will streamline the course of treatment and improve integration into different health care environments.”1
Researchers conducted a noninferiority study analyzing rapid induction with extended-release buprenorphine across multiple sites, including 729 patients with an average opioid use duration of 15 years. At induction, 77.5% of patients were fentanyl-positive, and participants were randomized 2:1 to rapid initiation (a single dose of 4 mg transmucosal buprenorphine [TM-BUP], followed by a buprenorphine extended-release injection within 1 hour) or standard induction (daily TM-BUP over 7 or more days) prior to receiving the first injection.1
The data indicated effective rapid induction, as shown by the primary end point of participant retention at the time of the second injection being reached, according to the study authors. Further, the proportion of participants who received the second injection was 66.4% in the rapid induction arm and 54.5% in the standard induction arm, according to Indivior data on file and the package insert for buprenorphine extended-release injection.1,3
"These label updates for [buprenorphine extended-release] underscore our dedication to evolving our treatment options to better serve individuals battling opioid use disorder," Christian Heidbreder, PhD, MD, chief scientific officer at Indivior, said in the news release.1
