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FDA Approves Buprenorphine Extended-release Injection for Moderate-to-Severe Opioid Use Disorder


Brixadi is the first and only long-acting buprenorphine injectable that is available in both weekly and monthly doses.



The US Food and Drug Administration (FDA) on May 24 approved Brixadi (buprenorphine) extended-release subcutaneous injection for the treatment of moderate-to-severe opioid use disorder (OUD).

The FDA granted approval of Brixadi to Braeburn Inc., and it is the first long-acting buprenorphine injectable that can be given in weekly doses to patients who have already initiated treatment with a single dose of a transmucosal buprenorphine product or who are already receiving treatment with a transmucosal buprenorphine-containing product, and in monthly doses for patients already being treated with buprenorphine, according to a May 23, 2023, Braeburn press release.

“Buprenorphine is an important treatment option for opioid use disorder. 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, in an agency press release.

The approved doses of Brixadi vary by frequency of use. The weekly doses include 8 mg, 16 mg, 24 mg, and 32 mg, and the monthly doses include 64 mg, 96 mg, and 128 mg. “The approved weekly formulation in various lower strengths offers a new option for people in recovery who may benefit from a weekly injection to maintain treatment adherence,” said the FDA.

Brixadi will be available through a Risk Evaluation and Mitigation Strategy program and will only be administered by health care providers in a health care setting, added the agency.

The FDA’s decision was based partly on safety and efficacy data from a randomized, double-blind, active-controlled phase 3 clinical trial in 428 adults with moderate-to-severe OUD, including those who injected opioids and heroin and had evidence of fentanyl exposure.

Following an initial test dose of transmucosal buprenorphine, patients were randomly assigned to Brixadi plus sublingual placebo or active sublingual buprenorphine plus placebo injections. After 7 days of titration, patients received weekly injections for 12 weeks and then switched to monthly injections for an additional 12 weeks. A response to treatment was measured by urine drug screening and self-reporting of illicit opioid use during the study period. Participants were considered “responders” if they had negative opioid assessments at the end of each of the 2 treatment phases. The proportion of participants meeting the responder definition was 16.9% in the Brixadi arm and 14.0% in the sublingual buprenorphine arm.

“A weekly and monthly buprenorphine injection with different dose options can align with clinical practice and patient care needs,” said the study’s primary investigator Michelle Lofwall, MD, professor, Behavioral Science and Psychiatry, University of Kentucky Center on Drug and Alcohol Research, in the Braeburn release. “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 one week or one month could benefit patients, their loved ones and the treatment providers.”

The most common adverse reactions associated with Brixadi included injection-site pain, headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia, and urinary tract infection, according to the FDA.

“The FDA will continue to take 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,” said Califf in the release.

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