Extended-release injectable buprenorphine (XR-BUP) in patients with opioid overdose can allow more time to access follow-up care while providing continued medication for a longer duration, according to early emergency department (ED) experience. The US Food and Drug Administration recently approved XR-BUP for the treatment of moderate to severe opioid use disorder.
A report on the early experience was published online on July 28 in the Academic Emergency Medicine.
The Emergency Department-INitiated bupreNOrphine VAlidaTION (ED INNOVATION) trial is a part of the NIH HEAL Initiative effort to expand access to opioid use disorder (OUD) medications in general medical settings, particularly EDs. It assesses the feasibility and effectiveness of the 7-day XR-BUP injectable for buprenorphine initiation in patients with untreated OUD. Approximately 1600 patients are enrolled to date from 28 diverse EDs in the United States, half of whom are receiving the XR-BUP formulation.
“These are individuals with untreated OUD, 18 years or older, who consent to be included in a trial of medication treatment with buprenorphine. They are randomized to the traditional sublingual dosing or the 7-day XR-BUP formulation,” lead author Gail D'Onofrio, MD, MS, professor of emergency medicine at the Yale School of Medicine, told Medscape Medical News.
Only 3% of eligible individuals have refused randomization, indicating a high willingness to participate.
“We are studying engagement in addiction treatment at 7 and 30 days post-enrollment,” D’Onofrio said.
Patients are observed in the ED for 2 hours after receiving the XR-BUP injection. They are then discharged with a follow-up appointment scheduled for comprehensive addiction treatment within 7 days. This appointment allows clinicians to continue the patient's treatment pathway and, if necessary, discuss further buprenorphine treatment options, including potential continuation with the newly approved 30-day XR-BUP injectable preparations.
Throughout the trial, ED nurses have been trained to administer the XR-BUP injection, which comes in prefilled syringes of 8, 16, 24, and 32 mg).
The 7-day XR-BUP injectable offers a unique advantage with its sustained-release mechanism, allowing for a smooth transition from the ED to outpatient care. The injection forms into a gel on administration, encapsulating the medication and releasing it at a steady rate over the course of 1 week. This characteristic effectively avoids the daily peaks and troughs associated with traditional buprenorphine dosing.
“The medication is similar to other injectables, the most important factor being to not inject in the arm,” said D’Onofrio.
Early experiences from the trial are encouraging, as both patients and clinicians have reported positive outcomes and prominent levels of satisfaction with the 7-day XR-BUP injectable. Patients have expressed gratitude for the stability of the injection during crucial initial stages of treatment, even in challenging circumstances like brief incarcerations.
“We clearly have eliminated some of the logistical issues urgently needing to fill prescriptions and obtain appointments for follow-up. They now have a 1-week lead-in,” D’Onofrio said. “After 1 week of medications, they can be in a better place to make long-term decisions about continual care.”
The trial not only improves our understanding of the efficacy and feasibility of the 7-day XR-BUP injectable but also offers a promising approach to addressing the barriers often encountered in OUD treatment initiation.
Divulging the next steps, D’Onofrio said that they “need to evaluate all aspects of the study, engagement in treatment being the primary outcome, but also satisfaction, overdose events, and many other factors that could predict the ability to continue to addiction treatment.”
Commenting on this study for Medscape Medical News, Wilson Compton, deputy director of the National Institute on Drug Abuse, part of the NIH, noted that EDs are “important public health touchpoints for reaching people with substance use disorders and offering them the option to start on treatment.”
“It is encouraging to see that offering people XR-BUP in the ED appears to be safe and well-tolerated,” said Compton.
“Improving access to and retention in treatment for OUD is crucial to address the overdose crisis that we are facing. Extended-release formulations of medications may offer unique benefits for people with substance use disorders who may struggle with access to daily medications,” he noted, looking beyond the immediate findings of the trial.
“The high level of patient satisfaction reported for XR-BUP suggests that this treatment option might help people sustain treatment, thereby supporting recovery and serving as a valuable tool for addressing the overdose crisis,” he said.
Academic Emergency Medicine. Published online July 28, 2023. Abstract
The trial is supported by the National Institutes of Health through the NIH HEAL Initiative, Department of Health and Human Services, and National Institute on Drug Abuse.
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