FDA approves rapid initiation of Sublocade for opioid use disorder

Key takeaways:

• The FDA approved label changes that include a rapid initiation protocol and alternative injection sites.
• The changes aim to shorten the time to achieve treatment effects in patients with opioid use disorder.

The FDA has approved label changes for once-monthly Sublocade, helping to reduce possible barriers to treatment initiation for opioid use disorder and speed up availability of treatment, according to a press release from the manufacturer.

These label changes include:

• a rapid initiation protocol, which allows health care providers to initiate Sublocade (buprenorphine extended-release, Indivior) after a single dose of transmucosal buprenorphine and a 1-hour observation period to confirm tolerability; and
• alternative administration sites, including subcutaneous injections into the buttock, thigh, abdomen and back of the upper arm.

The release noted that alternative injection sites provide patients with greater flexibility “so that they may be inclined to continue their treatment.”

Ultimately, the changes will shorten the time it takes to achieve the effects of Sublocade, which “provide continuous, reliable monthly protection against the effects of fentanyl and other opioids,” the release said.

In 2017, the FDA approved Sublocade for the treatment of moderate to severe opioid use disorder among adults who have started treatment with a product containing transmucosal buprenorphine and have been on a stable dose for at least 7 days.

Healio previously reported results from a randomized trial that showed that rapid initiation with Sublocade substantially improved treatment retention compared with standard initiation in patients with opioid use disorder.

Specifically, the rapid initiation resulted in an 11.8% overall improvement in retention rates and a 14.8% improvement among those who tested positive for fentanyl.

The researchers also reported that posterior probabilities showed that rapid initiation was 99.9% superior vs. standard initiation for the overall study population and 100% superior for those positive for fentanyl.

The label changes, which do not change Sublocade’s safety profile or efficacy, “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 the release.

“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,” Heidbreder added.