AcelRx Pharmaceuticals, Inc. Receives IDE Approval for Niyad and Advances to A Single Registration Study
October 03, 2023 at 08:30 am EDT
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AcelRx Pharmaceuticals, Inc. announced that it is advancing Niyad?? (a lyophilized formulation of nafamostat) into a registrational study following the recent approval of an Investigational Device Exemption (IDE) submission to the United States Food and Drug Administration (FDA). This clinical trial will evaluate the safety and efficacy of Niyad to support a premarket approval application (PMA) expected to be submitted in the second half of 2024.
The single study will consist of 166 adult patients undergoing renal replacement therapy (RRT) who cannot tolerate heparin or are at risk for bleeding. If approved, Niyad would be the first-ever FDA-approved regional anticoagulant for the extracorporeal circuit in the U.S. Key secondary endpoints include filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours.
Talphera, Inc., formerly 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 Company's 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 nafamostat formulation for direct intravenous (IV) infusion that shall be investigated and developed as a potential anti-viral for the treatment of COVID, acute respiratory distress syndrome (ARDS) disseminated intravascular coagulation (DIC), and acute pancreatitis. The Company is also engaged in developing two pre-filled syringes, namely Fedsyra and PFS-02.