AcelRx receives FDA approval for pivotal study of Niyad

AcelRx Pharmaceuticals is advancing Niyad into a registrational study following the recent approval of an Investigational Device Exemption – IDE – submission to the 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 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.