AcelRx Pharmaceuticals, Inc. Announces DSUVIA as Brand Name for ARX-04 in the United States
January 09, 2017 at 06:18 am
Share
AcelRx Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the brand name, DSUVIA (sufentanil sublingual tablet, 30 mcg), for the company's investigational product candidate, ARX-04. In addition, AcelRx has applied to the U.S. Patent and Trademark Office to obtain federal registration of the DSUVIA mark. AcelRx recently announced the submission of a New Drug Application (NDA) with the FDA for DSUVIA for the treatment of patients experiencing moderate-to-severe acute pain in a medically supervised setting. This market is comprised of the adult emergency department setting, ambulatory and outpatient surgical settings, short-stay inpatient settings and certain office settings that serve patients undergoing painful procedures. In total, based on internal market research and published national surveys, AcelRx expects the peak market for DSUVIA in the U.S. to be an estimated $1.1 billion. The FDA is expected to determine by mid-February 2017 whether the DSUVIA NDA is complete and acceptable for review. Should the Agency accept the NDA for review, a Prescription Drug User Fee Act (PDUFA) decision could be expected in 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.