AcelRx Pharmaceuticals, Inc. provided guidance on 2017 milestones for its lead product, ARX-04, known as DSUVIA™ (sufentanil sublingual tablet, 30 mcg) in the United States. Specifically, the company’s corporate milestones for DSUVIA and ARX-04 in the upcoming year are as follows: Advance the NDA. AcelRx submitted a 505(b)2 new drug application (NDA) for DSUVIA for moderate-to-severe acute pain in a medically supervised setting on December 12, 2016. The U.S. Food and Drug Administration (FDA) has 60 days to review an application and determine whether the NDA is acceptable for filing. The company expects to receive this notification from the FDA in the first quarter of 2017. Assuming the FDA, through the Division of Anesthesia, Analgesia and Addiction Products (Division), accepts the NDA for filing, AcelRx will liaise with the Division and any advisory committees that may be convened during the review period. Submit the European Regulatory Application. The company expects to submit a Marketing Authorization Application (MAA) under the Centralized Procedure for ARX-04 with the European Medicines Agency (EMA) in the first half of 2017. Plan for U.S. Approval and Commercialization. Should the Division favorably complete its review by the expected Prescription Drug User Fee Act (PDUFA) date, the company anticipates being prepared to begin commercialization of DSUVIA as early as the fourth quarter of 2017.