FDA grants tentative approval of Brixadi for severe opioid use disorder.- Braeburn Pharma.

Braeburn Pharma announced that the FDA has granted tentative approval of Brixadi (buprenorphine fluidcrystal injection) extended-release weekly (8mg, 16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) injections. The tentative approval is for use of Brixadi for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. Brixadi is administered only by healthcare providers (HCPs) in a healthcare setting and used as part of a complete treatment program that includes counseling and psychosocial support. With tentative approval, FDA has concluded that Brixadi has met all required quality, safety and efficacy standards necessary for approval, but is not eligible for marketing in the U.S. because of exclusivity considerations.

In a pivotal Phase III efficacy and safety trial evaluating the range of weekly and monthly doses, Brixadi was titrated to effect in a blinded fashion. Brixadi met the primary endpoint of non-inferiority for responder rate versus daily sublingual buprenorphine/naloxone (SL BPN/NX). The trial included real-world patients: 26% tested positive for fentanyl prior to study randomization, 71% were using heroin at study initiation and 52% were using injectable opioids at study initiation. For the trial's key secondary endpoint, Brixadi demonstrated superiority to SL BPN/NX in the percentage of negative opioid assessments from week 4 through 24 (p=0.004). Brixadi is the only injectable buprenorphine studied against the standard of care (SL BPN/NX), with no opioid overdoses in patients receiving Brixadi during clinical trials.

The safety profile of Brixadi was generally consistent with the known safety profile of oral buprenorphine with the exception of mild-to-moderate injection-site reactions. The most common adverse reactions (occurring in at least 5% of patients) included injection-site pain, headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia and urinary tract infections.