Brixadi, Sublocade competitor, resubmits application to FDA

Abstract

While the Food and Drug Administration (FDA) granted tentative approval to Brixadi, a weekly and monthly injection of buprenorphine in December 2018, Indivior's Sublocade has exclusivity. Now Braeburn, owner of Brixadi, is back at the FDA with a resubmission for a New Drug Application, after the FDA cited deficiencies during an inspection at a third‐party manufacturing facility, according to the Pennsylvania‐based company. “Braeburn has worked closely with the third‐party manufacturer to address the deficiencies identified” by the FDA, the company stated in a June 15 press release. Brixadi is an extended‐release weekly (8 mg, 16 mg, 24 mg and 32 mg) and monthly (64 mg, 96 mg and 128 mg) injection for subcutaneous use that is under review by the FDA 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. “If approved, Brixadi would be used as part of a complete treatment plan to include counseling and psychosocial support,” according to the press release. “During the clinical development program, 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.”