FDA Grants Braeburn’s Petition Allowing BRIXADI Extended-Release Injection For Addiction Treatment

Braeburn Inc. recently announced that it will seek, and is eligible for, marketing approval for BRIXADI™ (buprenorphine) weekly and monthly extended-release injection for the treatment of opioid use disorder (OUD) as of December 1, 2020. This follows from the recent decision by the U.S. Food and Drug Administration (FDA) to grant Braeburn’s Citizen Petition and thereby revoke Indivior PLC’s orphan designation for buprenorphine treatment for OUD. By revoking Indivior’s orphan designation, Sublocade™ (buprenorphine extended-release) injection is not eligible for any period of orphan exclusivity.

In a separate communication to Braeburn in response to the . . .