Braeburn requests final FDA approval for buprenorphine drug

Braeburn requests final FDA approval for buprenorphine drug

Braeburn, a company creating solutions for opioid use disorder, is seeking final approval from the U.S. Food and Drug Administration (FDA) for its drug BRIXADI (buprenorphine).

The drug is an extended-release injection for the treatment of opioid use disorder (OUD). It would be available in weekly and monthly versions and four-dose sizes ranging from 8 to 32 milligrams.

The company anticipates a six-month review cycle and forecasts final approval will be given on Dec. 1.

The FDA tentatively approved the drug in 2018 for patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are being treated with buprenorphine. The approval is for patients with moderate to severe OUD.

“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,” Mike Derkacz, Braeburn president and CEO, said. “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.”

The drug will not be eligible for marketing until the final approval.