The US Food and Drug Administration (FDA) has recently approved the use of buprenorphine extended-release injection, also known as Brixadi, for subcutaneous use in the treatment of patients with moderate to severe opioid use disorder (OUD). This approval expands dosing options and offers patients a greater opportunity to sustain long-term recovery.
Buprenorphine is available in both a weekly and monthly injection formulation and is approved at varying doses, including lower doses that could be more appropriate for patients who do not tolerate higher doses of extended-release buprenorphine. The weekly doses come in 8 mg, 16 mg, 24 mg, and 32 mg, while the monthly doses are available in 64 mg, 96 mg, and 128 mg.
The approval for this drug is based on the results of a behavioral pharmacology study that assessed the drug in two weekly doses to block the subjective effects of opioids. Additionally, a randomized and double-blind clinical trial involving 428 adults with OUD was conducted, further validating the effectiveness of buprenorphine as a treatment option.
While the drug has been approved, safety data analysis has indicated that the most common adverse reactions include injection-site pain, headache, constipation, nausea, injection-site erythema, itchy skin at the injection site, insomnia, and urinary tract infections. However, the benefits of the drug outweigh the potential risks and side effects.
FDA Commissioner Robert M. Califf, MD, noted that buprenorphine is an important treatment option for opioid use disorder. He believes that the FDA will continue taking the necessary steps to pursue evidence-based treatments for substance use disorders, which is a strategic priority under the FDA’s Overdose Prevention Framework.
Overall, the FDA’s approval of Brixadi for subcutaneous use in the treatment of opioid use disorder is a step forward in providing patients with more effective and safe treatment options for their condition.