Talphera Announces Agreement With The FDA For Prior Approval Supplement Review To Reduce The Number Of Patients In The NEPHRO CRRT Study

Submission of a Prior Approval Supplement for a reduction in the number of patients in the NEPHRO CRRT study is expected within the coming week

The FDA agreed to two additional protocol changes expected to accelerate enrollment in the NEPHRO CRRT study

SAN MATEO, Calif., Jan. 14, 2025 /PRNewswire/ -- Talphera, Inc. (NASDAQ:TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that following a meeting with the U.S. Food and Drug Administration (FDA), the agency has agreed to review a Prior Approval Supplement (PAS) requesting a reduction in the number of patients in the NEPHRO CRRT clinical 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 (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.