FDA Approves Buprenorphine Extended-Release Subcutaneous Injection for OUD


This treatment is the first and only long-acting buprenorphine injectable with weekly and monthly doses.

The FDA has approved buprenorphine (Brixadi) extended-release injection for subcutaneous use to treat moderate to severe opioid use disorder and will be available through the Brixadi REMS Program.1,2 Brixadi is available in 2 formulations: a weekly injection for patients who have just started treatment, and a monthly version for patients already being treated with a transmucosal buprenorphine-containing product.

“Today’s approval expands dosing options and provides people with opioid use disorder a greater opportunity to sustain long-term recovery,” said FDA Commissioner Robert M. Califf, MD.1 “The FDA will continue the critical steps necessary to pursue efforts that advance evidence-based treatments for substance use disorders, which is a strategic priority under the FDA’s Overdose Prevention Framework.”

Available in September 2023, Brixadi is only available in a health care setting, administered by health care providers. Due to the risk of serious harm from accidental IV administration, Brixadi contains a boxed warning. Health care providers and pharmacies that order and dispense this medication must be certified through the Brixadi REMS program and comply with all requirements.

Brixadi injections are available in varying doses, including lower doses appropriate for patients who cannot tolerate the higher doses of extended-release buprenorphine that are currently available.1 Weekly doses are available in 8, 16, 24, and 32 mg; monthly doses are available in 64, 96, and 128 mg.

In a phase 3, 24-week, randomized, double-blind safety and efficacy trial, investigators studied Brixadi against sublingual buprenorphine/naloxone in a cohort of 428 adults with moderate to severe opioid use disorder. Patients included those who injected opioids, used herion, had evidence of fentanyl use, and/or used nonopioid substances at screening. At the conclusion of the study, weekly and monthly Brixadi met the primary study endpoint of noninferiority for responder rate vs daily sublingual buprenorphine/naloxone from week 4 through 24.

“A weekly and monthly buprenorphine injection with different dose options can align with clinical practice and patient care needs,” said Michelle Lofwall, MD, professor of behavioral science and psychiatry at the University of Kentucky Center on Drug and Alcohol Research; Lofwall was also the primary investigator in the phase 3 study.2 “Some patients need help with taking their medication as prescribed, some prefer not taking a daily medication or visiting a pharmacy to pick up their medication, so having a weekly and monthly option that provides buprenorphine over 1 week or 1 month could benefit patients, their loved ones, and the treatment providers.”

The safety profile of this medication was “consistent with the known systemic safety profile” of oral buprenorphine, with the exception of mild to moderate injection site reactions.2 Common adverse reactions included injection site pain, headache, constipation, nausea, injection site erythema or pruritus, insomnia, and urinary tract infections.

  1. FDA approves new buprenorphine treatment option for opioid use disorder. News release. FDA. May 23, 2023. Accessed May 24, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-buprenorphine-treatment-option-opioid-use-disorder
  2. Braeburn’s Brixadi (buprenorphine) extended-release subcutaneous injection (CIII) receives FDA approval for moderate to severe opioid use disorder. News release. Braeburn. May 23, 2023. Accessed May 24, 2023. https://www.prnewswire.com/news-releases/braeburns-brixadi-buprenorphine-extended-release-subcutaneous-injection-ciii-receives-fda-approval-for-moderate-to-severe-opioid-use-disorder-301832521.html 
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