AcelRx Pharmaceuticals, Inc. Provides Update for ARX-04 for the Treatment of Moderate-To-Severe Acute Pain
January 08, 2017 at 08:02 am EST
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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.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company. The Company is focused on the development and commercialization of therapies for use in medically supervised settings. The Companyâs nafamostat product candidates include Niyad and LTX-608. Niyad is focused on developing regional anticoagulants for injection into the extracorporeal circuit, such as the dialysis circuit during continuous renal replacement therapy (CRRT) for acute kidney injury (AKI) patients in the hospital, and for chronic kidney disease patients undergoing intermittent hemodialysis (IHD) in dialysis centers. LTX-608 is its nafamostat formulation for direct intravenous (IV) infusion being explored as an investigational product for the antiviral treatment of COVID, acute respiratory distress syndrome (ARDS) disseminated intravascular coagulation (DIC), and acute pancreatitis. Its pre-filled syringe product candidates include Fedsyra and Phenylephrine.