Dsuvia Approval May Be Followed By New Opioid Review Paradigm At FDA

02 Nov 2018

• By Michael Cipriano

US FDA Commissioner Gottlieb defended the decision to clear the controversial opioid in the agency’s press release on the approval, and announced a possible shift in how future opioid applications are reviewed.

In announcing the US FDA's approval of AcelRx Pharmaceuticals Inc.'s controversial opioid Dsuvia (sufentanil sublingual), Commissioner Scott Gottlieb not only offered the agency's defense of the decision, but also revealed that the agency will be exploring a shift in the paradigm of how it reviews future opioid applications.

FDA backed AcelRx Pharmaceuticals Inc.'s Dsuvia (sufentanil sublingual) Nov. 2 for the management of acute pain severe enough to require...