Braeburn’s Long-Acting Brixadi Receives FDA Clearance to Treat Opioid Use Disorder

Pictured: Opioids on table top

Pictured: Prescription drugs and opioids on table top/Courtesy, AdobeStock, Stock Footage, Inc. 

Braeburn Pharmaceuticals has received the go-ahead from the FDA for its long-acting therapy, Brixadi, to treat opioid use disorder.

Brixadi, a weekly and monthly medication for treating moderate to severe opioid use disorder (OUD), reduces cravings and withdrawal symptoms and supports long-term abstinence from opioids. The company plans to provide support services and resources to assist healthcare professionals and patients in maximizing the benefits of Brixadi therapy.

The medication, approved for extended-release injection for subcutaneous use, is a formulation of buprenorphine designed for patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a daily buprenorphine product. Brixadi’s extended-release feature distinguishes it from existing treatment options that typically require daily dosing. Brixadi stands to improve patient adherence to treatment plans by eliminating the need for frequent administration, a common stumbling block.

“Over the last three years, the U.S. experienced a significant increase in opioid overdoses in part related to the economic and social upheaval that negatively impacted all of us, especially people with opioid use disorder and people in recovery,” Mike Derkacz, president and CEO, Braeburn said in a statement.

On Monday, the FDA approved Indivior PLC’s nalmefene nasal spray, now to carry the brand name Opvee, for the emergency treatment of confirmed or suspected opioid overdose.

In March, the FDA approved Narcan nasal spray for over-the-counter nonprescription use—the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose.

Braeburn conducted a clinical trial with 428 adults diagnosed with moderate-to-severe opioid use disorder, according to the statement released by the FDA.

Participants initially received a test dose of transmucosal buprenorphine and were randomly assigned to one of two treatment groups. The first group received Brixadi along with a sublingual placebo, while the second group received active sublingual buprenorphine along with placebo injections. Patients underwent a titration period in the first week and then received weekly injections for 12 weeks, then transitioned to monthly injections for an additional 12 weeks.

Researchers assessed the response to treatment by measuring urine drug screening and self-reporting illicit opioid use during the treatment period. Patients were considered “responders” if they had negative opioid assessments at the end of the two treatment phases. The study found that 16.9% of patients in the Brixadi group and 14.0% in the sublingual buprenorphine group met the criteria for responders.

According to the Substance Abuse and Mental Health Services Administration, buprenorphine has been established as a safe and highly effective medication for treating OUD.

SAMHSA and the FDA noted that the approval aligns with the national strategy to address the opioid crisis, emphasizing the importance of evidence-based treatment options, according to the Department of Health and Human Services. By expanding the range of available treatments, healthcare providers can tailor their approach to each patient's needs and circumstances, improving the likelihood of sustained recovery.

Lisa Munger is a senior editor at BioSpace. You can reach her at Follow her on LinkedIn.

Back to news