Specialty pharmaceutical company Talphera Inc (Nasdaq: TLPH) announced on Tuesday that following a meeting with the US Food and Drug Administration (FDA), the agency has agreed to review a Prior Approval Supplement (PAS) requesting a reduction in the number of patents in the NEPHRO CRRT clinical study of Niyad, a lyophilized formulation of nafamostat.

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 expand the clinical study inclusion criteria that will allow Talphera to enrol patients already on continuous renal replacement therapy (CRRT) beyond 48 hours and 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 needed.

Shakil Aslam, MD, Talphera's chief medical officer, said: "We continue to evaluate and focus on opportunities to support completion of the NEPHRO CRRT study by the end of the year. In addition to new clinical sites, our continuous improvement efforts in study execution were strengthened following our positive face-to-face meeting with the FDA where the agency agreed we should submit a PAS to reduce the number of patients in the NEPHRO CRRT study. We plan to submit the PAS in the coming week which requires a review period of up to 30 days. Our breakthrough designation status and close collaboration with the FDA continue to support our confidence in the importance of nafamostat as an alternative anticoagulant for patients on CRRT."