FDA has approved buprenorphine extended-release injection (Brixadi—Braeburn) for the treatment of moderate to severe opioid use disorder (OUD). The drug is available as a weekly dose for patients who have started treatment with a single dose of a transmucosal buprenorphine product and as a monthly version for patients already being treated with buprenorphine.
“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 a press statement.
The Substance Abuse and Mental Health Services Administration (SAMHSA) estimates that patients who receive medication for their OUD reduce their risk of death from all causes by one-half.
FDA and SAMHSA recently released a joint letter to clarify the importance of counseling and other services as part of a comprehensive treatment plan for OUD and to stress that supplying buprenorphine should not be made contingent upon participation in such services.
Lower doses of subcutaneous buprenorphine extended-release injections may be appropriate for those who do not tolerate higher doses of the drug that are currently available.
The weekly doses are available in 8 mg, 16 mg, 24 mg, and 32 mg, while the monthly doses are 64 mg, 96 mg, and 128 mg doses.
The new doses will be available through a REMS program and administered only by health care providers in a health care setting.
Common adverse reactions include headache, nausea, injection-site pain, constipation, injection-site erythema, insomnia, itchy skin at the injection site, and urinary tract infections.
The safety and efficacy of buprenorphine was assessed in a behavioral pharmacology study to gauge the ability of two weekly doses of buprenorphine to block the subjective effects of opioids and a randomized, double-blind, active-controlled clinical trial in 428 adults with a diagnosis of moderate to severe OUD.