Brixadi FDA Approval History
Last updated by Judith Stewart, BPharm on May 29, 2023.
FDA Approved: Yes (First approved May 23, 2023)
Brand name: Brixadi
Generic name: buprenorphine
Dosage form: Extended-Release Injection
Company: Braeburn Inc.
Treatment for: Opioid Use Disorder
Brixadi (buprenorphine) is a partial opioid agonist for use in the treatment of opioid use disorder.
- Brixadi is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product, or who are already being treated with buprenorphine. Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support.
- Opioid use disorder (OUD) is a condition caused by the chronic use of opioids which results in clinically significant distress or impairment. OUD consists of an overpowering desire to use opioids, increased opioid tolerance, and withdrawal syndrome when discontinued.
- Brixadi contains buprenorphine, an established treatment for opioid use disorder that works as a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Buprenorphine is also available for the treatment of opioid use disorder under the brand name Sublocade.
- Brixadi is administered as a subcutaneous injection into the buttock, thigh, abdomen, or upper arm. It is supplied as a pre-filled single-dose syringe in weekly (buprenorphine 50 mg/mL) and monthly (buprenorphine 356 mg/mL) formulations.
- Buprenorphine is a Schedule III controlled substance. After administration of Brixadi, syringes should be properly disposed, per facility procedure for a Schedule III drug product, and per applicable federal, state, and local regulations.
- The Brixadi product label carries a Boxed Warning for the risk of serious harm or death if administered intravenously. Brixadi forms a liquid crystalline gel upon contact with body fluids which can occlusion, local tissue damage, and thrombo‐embolic events if administered intravenously.
- Due to the risk of serious harm resulting from accidental intravenous administration, Brixadi is only available though a restricted distribution program called the Brixadi Risk Evaluation and Mitigation Strategy (REMS). Healthcare settings and pharmacies that order and dispense Brixadi must be certified in this program and comply with the REMS requirements.
- Warnings and precautions associated with Brixadi include addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; adrenal insufficiency; risk of opioid withdrawal with abrupt discontinuation; risk of hepatitis and hepatic events; latex allergy; risk of withdrawal in patients dependent on full agonist opioids; and treatment of emergent acute pain which may require higher doses of opioids for analgesic effect.
- Common adverse reactions inlcude injection site pain, headache, constipation, nausea, injection site erythema, injection site pruritus, insomnia, and urinary tract infection.
Development timeline for Brixadi
Further information
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