Braeburn asks FDA to revoke Sublocade's orphan designation

Abstract

Braeburn, which makes Brixadi, a buprenorphine injection, has filed a Citizen Petition calling on the Food and Drug Administration (FDA) to revoke “orphan designation” — exclusivity — for Sublocade, Indivior's injectable buprenorphine. Saying that unless the FDA does this, no competitive buprenorphine opioid use disorder (OUD) treatment will enter the market until 2024, Braeburn said the Orphan Drug Act was enacted to treat rare conditions with small patient populations. In some cases, the act is utilized even if a large population could benefit, if there is “no reasonable expectation” of recovering developing and marketing costs. Indeed, orphan drug designation (ODD) was granted to Subutex (buprenorphine) in 1994, when Indivior's predecessor was the sponsor. Now the FDA has “grandfathered” the Subutex designation to Sublocade “simply because the developer of Subutex and Sublocade is the same,” according to a press statement from Braeburn released earlier this month.