FDA Approves Updated Buprenorphine Label For Rapid Initiation Treatment
The updated label also includes alternative injection sites, such as the abdomen, thigh, buttock, or back of the upper arm.
The FDA approved a label change for buprenorphine extended-release injection (Sublocade), which now includes a rapid initiation protocol and alternative injection sites, for the treatment of moderate to severe opioid use disorder (OUD).1
The rapid initiation protocol states that health care providers can now initiate treatment with the drug after a single dose of transmucosal buprenorphine and a 1-hour observation period | Image Credit: mnimage | stock.adobe.com
The rapid initiation protocol states that health care providers can now initiate treatment with the drug after a single dose of transmucosal buprenorphine and a 1-hour observation period. For the injection site, the subcutaneous injection can now be administered in the abdomen, thigh, buttock, or back of the upper arm.1
"These label updates for Sublocade underscore our dedication to evolving our treatment options to better serve individuals battling opioid use disorder," Christian Heidbreder, PhD, chief scientific officer at Indivior, said in a news release.1 "These enhancements not only reflect our commitment to patient-centered care but also our ongoing efforts to align our treatments with real-world clinical needs, thereby potentially improving patient adherence and outcomes."
In phase 2 (NCT01738503) and phase 3 (NCT02357901) trials, investigators aimed to reevaluate the understanding of buprenorphine’s pharmacokinetics and ability to deliver and maintain target plasma exposure during the treatment duration. The studies were conducted in individuals with OUD who were seeking treatment. In each study, the drug was administered in a run-in phase of 4 to 14 days, which included an induction dose and a dose stabilizer with sublingual buprenorphine.2
The findings showed that 2 monthly doses of 300 mg, followed by 100 mg monthly, achieved the target concentrations of 2 ng/mL from the first injection. Investigators reported that the plasma concentrations were sustained over 2 ng/mL over the entire treatment duration for the majority of patients. With the monthly administration of 300 mg, the plasma concentrations were in the range of 5 to 10 ng/mL, according to the results.2
Additionally, investigators conducted a non-inferiority study to support the rapid induction of the drug, which included 729 patients with a mean age of 40.7 years and an average opioid use of 15 years. At induction, 77.5% were fentanyl-positive, and patients were randomized at a 2:1 ratio for rapid initiation or the standard induction of daily transmucosal buprenorphine over 7 or more days before the first injection.
The findings showed that rapid induction was effective, demonstrating patient retention at the second dose. In both treatment groups, the second 300 mg injection was administered after the first injection, and subsequent injections were scheduled every 4 weeks. Approximately 66.4% in the rapid induction arm received the second injection, compared with 54.5% in the standard of care arm. Further, the estimated retention rate difference in the overall population was 11.8% with a lower bound of multiplicity adjusted 2-sided 95% confidence interval greater than the prespecified noninferiority margin of -10%, according to the prescribing data.1,3
Buprenorphine is a partial opioid agonist indicated for the treatment of moderate to severe opioid use disorder for patients who have initiated treatment with a single dose of transmucosal buprenorphine or for those who are already receiving buprenorphine.3
READ MORE: Mental and Behavioral Health Resource Center
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