Talphera reaches agreement with FDA in Nephro CRRT study

Talphera (TLPH) announced that following a meeting with the FDA, the agency has agreed to review a Prior Approval Supplement requesting a reduction in the number of patients in the NEPHRO CRRT clinical study. Talphera’s registrational study of Niyad is named the NEPHRO CRRT study. A PAS is reviewed by the FDA within 30 days, and its approval by the agency is required before formally amending the study protocol. During this same meeting, the agency agreed to two other changes to broaden the clinical study inclusion criteria which would allow the company to enroll patients already on continuous renal replacement therapy, or CRRT, beyond 48 hours as well as heparin-tolerant patients at certain institutions. These changes are being made through a five-day protocol amendment notice to the FDA with no additional FDA review required.