Braeburn Submits Request for Final Approval of BRIXADI for Opioid Use Disorder

Braeburn has requested final approval from the U.S. Food and Drug Administration (FDA) of the New Drug Application for BRIXADI™ (buprenorphine) weekly and monthly extended-release injection for the treatment of opioid use disorder (OUD). Once approved, BRIXADI will be the only long-acting injectable buprenorphine that offers a range of doses in both weekly and monthly formulations that allow healthcare providers (HCPs) to tailor treatment to the patient's needs. Braeburn anticipates a 6-month review cycle resulting in final approval on December 1, 2020.

"Approximately 48,000 Americans died from an opioid overdose in 2019 and that number is expected to climb in 2020 as a result of the economic and social impacts of the COVID-19 pandemic," said Mike Derkacz, President and CEO of Braeburn. "Now more than ever, patients with OUD need a variety of treatment options, and we expect that BRIXADI will offer HCPs and their patients a new choice at a time when there is a greater need for treatment availability."

In December 2018, BRIXADI was tentatively approved for the treatment of moderate to severe OUD but is not eligible for marketing in the U.S. until December 1, 2020, because of exclusivity considerations. With tentative approval, FDA concluded that BRIXADI met all required quality, safety, and efficacy standards necessary for approval.

The results from the pivotal Phase 3 efficacy and safety trial demonstrate that BRIXADI met the primary endpoint of non-inferiority for responder rate (p<0.001) versus treatment with the current standard of care, sublingual buprenorphine/naloxone, and demonstrated superiority for the secondary endpoint for the percentage of negative opioid assessments from week 4 through 24 (p=0.004). BRIXADI weekly and monthly was also effective in reducing opioid withdrawal and cravings and maintaining low withdrawal and craving scores in the trial, as published in JAMA Internal Medicine. BRIXADI is the only injectable buprenorphine studied against the current standard of care, sublingual buprenorphine/naloxone.

The safety profile from completed clinical studies of BRIXADI is generally consistent with the known safety profile of oral buprenorphine except for mild-to-moderate injection-site reactions. The most common adverse reactions (occurring in ≥5% of patients) included injection-site pain, headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia, and urinary tract infections.

BRIXADI is an extended release weekly (8mg, 16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) injection used for the treatment of moderate to severe OUD. BRIXADI is tentatively approved by FDA for patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. BRIXADI will be administered only by healthcare providers in a healthcare setting and used as part of a complete treatment program that includes counseling and psychosocial support.