FDA accepts re-submission of Dsuvia a proposed treatment for moderate to severe pain in medically supervised settings.- Ace1Rx Pharma

AcelRx Pharmaceuticals, Inc. announced the FDA acceptance of its New Drug Application (NDA) re-submission for Dsuvia (sufentanil sublingual tablet), a new, non-invasive treatment option for the management of moderate-to-severe acute pain for adult patients in medically supervised settings.

The FDA considers the Dsuvia NDA re-submission a complete class 2 response to their October 2017 action letter. Therefore, the FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of 3 November 2018.