Core Viewpoint - Talphera, Inc. is advancing its NEPHRO CRRT clinical study with FDA's agreement on protocol changes aimed at accelerating patient enrollment and reducing the number of patients required for the study [1][2][3] Group 1: FDA Interactions and Protocol Changes - The FDA has agreed to review a Prior Approval Supplement (PAS) for a reduction in the number of patients in the NEPHRO CRRT study, which is expected to be submitted within the coming week [1] - Two additional protocol changes have been approved by the FDA to broaden inclusion criteria, allowing enrollment of patients on continuous renal replacement therapy (CRRT) beyond 48 hours and heparin-tolerant patients at certain institutions [2] - The PAS review by the FDA will take up to 30 days, and the company is optimistic about completing the study by the end of the year [3] Group 2: Product and Study Details - Talphera's lead product candidate, Niyad™, is a lyophilized formulation of nafamostat, currently under investigation as an anticoagulant for the extracorporeal circuit and has received Breakthrough Device Designation from the FDA [4][6] - The NEPHRO CRRT study aims to enroll 166 adult patients undergoing renal replacement therapy who cannot tolerate heparin or are at risk for bleeding, with primary and secondary endpoints focused on clotting time and dialysis efficacy [7]
Talphera Announces Agreement with the FDA for Prior Approval Supplement Review to Reduce the Number of Patients in the NEPHRO CRRT Study