FDA Approves New Buprenorphine Treatment Option for Opioid Use Disorder
For Immediate Release: May 24, 2023
Today, the U.S. Food and Drug Administration (FDA) approved the extended-release Brixadi (buprenorphine) subcutaneous (for use under the skin) injection to treat moderate to severe opioid use disorder (OUD). Brixadi is available in two formulations, a weekly injection that can be used in patients who have started treatment with a single dose of a buprenorphine-containing product administered transmucosally or who are already being treated with buprenorphine and a monthly version for patients who are already being treated with buprenorphine.
"Buprenorphine is an important treatment option for opioid use disorder. Today's approval expands dosing options and gives people with opioid use disorder a greater opportunity to maintain a lasting recovery," said FDA Commissioner Robert M. Califf, M.D. "The FDA will continue to take important steps necessary to undertake efforts to advance evidence-based treatments for substance use disorders, which is a strategic priority under the FDA's Overdose Prevention Framework."
Buprenorphine is a safe and effective medication for the treatment of opioid use disorder. According to the Substance Abuse and Mental Health Administration (SAMHSA), patients who receive medication for opioid use disorder cut their risk of death from all causes in half.
The FDA continues to implement a comprehensive approach to increase options for treating opioid use disorder. Earlier this month, the agency issued a joint letter with SAMHSA to clarify the importance of counseling and other services as part of a comprehensive treatment plan for opioid use disorder and also to reiterate that the provision of buprenorphine should not be contingent on participation in such services. The agency also held a virtual public workshop that highlighted the need for additional concentrations and dosing regimens for extended-release formulations.
Brixadi is approved in weekly and monthly subcutaneous injectable formulations in varying doses, including lower doses that may be appropriate for those who cannot tolerate the higher doses of extended-release buprenorphine that are currently available. Weekly doses are 8 milligrams (mg), 16 mg, 24 mg, 32 mg; and the monthly doses are 64 mg, 96 mg, 128 mg. The approved weekly formulation in several lower concentrations offers a new option for people in recovery who may benefit from a weekly injection to maintain adherence to treatment. Brixadi will be available through a Risk Assessment and Mitigation Strategy (REMS) program and will be administered solely by health care providers in a health care facility.
The most common adverse reactions (occurring in ≥5% of patients) with Brixadi include pain at the injection site, headache, constipation, nausea, erythema at the injection site, itchy skin at the injection site (injection site pruritus), insomnia, and urinary tract infections.
The safety and efficacy of Brixadi were evaluated in a behavioral pharmacology study that evaluated the ability of two weekly doses of Brixadi to block the subjective effects of opioids and in a randomized, double-blind, controlled clinical trial with an active substance in 428 adults diagnosed with moderate to severe opioid use disorder. After an initial trial dose of buprenorphine administered transmucosally, patients were randomized to treatment with Brixadi plus a sublingual placebo or active sublingual buprenorphine plus placebo injections. After assessment during the first week, patients were treated with weekly injections for 12 weeks and then moved on to monthly injections for an additional 12 weeks. Response to treatment was measured by detection of drugs in urine and self-reporting of illicit opioid use during the treatment period. Patients were considered to be responsive if they had negative opioid assessments at the end of each of the two treatment phases. The proportion of patients who met the definition of responder was 16.9% in the Brixadi group and 14.0% in the sublingual buprenorphine group.
The FDA granted approval of Brixadi to Braeburn Inc.
The agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose, and death in the United States through the FDA's Overdose Prevention Framework. The framework's priorities include: supporting primary prevention by eliminating unnecessary initial exposure to prescription drugs and inappropriate long-term prescribing; fostering harm reduction through innovation and education; advancing the development of evidence-based treatments for substance use disorders; and protect the public from unapproved, diverted, or falsified drugs that pose overdose risks.