The FDA has approved a slow-release subcutaneous injection of buprenorphine (Brixadi, Braeburn Inc) to treat moderate-to-severe opioid use disorder (OUD).
The drug is available as a weekly injection for patients who started treatment with a single dose of a transmucosal buprenorphine product or who are already taking buprenorphine and a monthly injection for patients who are already taking buprenorphine. Available in two formulations for injection.
“Buprenorphine is an important treatment option. [OUD]. Today’s approval expands dosing options, providing people with: [OUD] This is a great opportunity to sustain long-term recovery,” FDA Commissioner Robert M. Calif, M.D., said in a press release. “FDA continues to take the important steps necessary to advance efforts to advance evidence-based treatments for drug use disorders, which is a strategic priority under the FDA’s Overdose Prevention Framework. .”
Buprenorphine injection has been approved for weekly and monthly dosing at a variety of doses, including lower doses for those who cannot tolerate the higher doses of sustained-release buprenorphine currently available. Weekly strengths include 8 mg, 16 mg, 24 mg, and 32 mg. Monthly strengths include 64 mg, 96 mg and 128 mg.
The weekly formulation features a range of lower concentrations, making it a new option for recovering patients who benefit from weekly injections to maintain medication adherence.
This decision was based on evaluation in a behavioral pharmacology study, evaluation of twice-weekly drug administration and its ability to block the subjective effects of opioids, and randomized double-blindness in 428 individuals with the following diagnoses: It was passed through a probate-controlled clinical trial. His OUD being offered from medium.
After the initial trial of transmucosal buprenorphine, study participants were randomized to receive either buprenorphine injection plus sublingual placebo or active buprenorphine sublingual plus placebo injection.
After the first week of titration, patients were treated with weekly injections for 12 weeks, eventually transitioning to monthly injections for another 12 weeks.
Investigators used urine drug screening and self-reported illicit opioid use during treatment to measure response to treatment. A negative opioid assessment at the end of each of the two treatment phases was considered responsive to the drug.
Approximately 16.9% of individuals in the buprenorphine injection group were responders compared to 14% in the sublingual buprenorphine group.
The most common side effects include injection site pain, headache, constipation, nausea, injection site erythema, injection site pruritus, insomnia, and urinary tract infections.
Buprenorphine Injection will be available through the FDA’s Risk Assessment and Mitigation Strategies Program and will be administered by point-of-care physicians.
Earlier this month, the FDA issued a joint letter with the Office of Substance Abuse and Mental Health Services, clarifying the importance of counseling and other services should be included in treatment plans for OUD. They also said the supply of buprenorphine should not be dependent on individuals participating in these services.
reference
FDA approves new buprenorphine treatment option for opioid use disorder. news release. US Food and Drug Administration. May 23, 2023. Accessed May 24, 2023. https://www.fda.gov/news-events/press-payments/fda-approves-new-buprenorphine-treatment-option-opioid-use-disorder?utm_medium=email&utm_source = Government Delivery