CorMedix says Neutrolin Phase 3 clinical development complete after FDA feedback
CorMedix announced that it has received feedback from the U.S. FDA regarding the submitted statistical analyses of data and additional information requested by the FDA for the primary and secondary efficacy endpoints of the Company's LOCK-IT-100 clinical study. LOCK-IT-100 examined the safety and effectiveness of the investigational new drug Neutrolin as a catheter lock solution compared to heparin for the prevention of catheter-related bloodstream infection in hemodialysis patients. Based on the FDA's feedback, the Company believes it has completed Phase 3 of clinical development for Neutrolin in hemodialysis patients and does not need to conduct another clinical trial at this time. In its feedback, the FDA did not raise any additional questions regarding the analyses provided and indicated that it would conduct a thorough review of all of the clinical data when the clinical study report is submitted for LOCK-IT-100. In FDA's response to the Company's question on whether LOCK-IT-100 is adequate as a single study to support a New Drug Application, the FDA stated that while the data from LOCK-IT-100 and supporting information may be sufficient, it cannot confirm that the data from LOCK-IT-100 are adequate to support an indication for prevention of CRBSI in hemodialysis patients until it has completed its review of the NDA. The Company will continue discussions with the FDA concerning the chemistry, manufacturing and controls data that will be needed to support Neutrolin's NDA. FDA's feedback on the CMC data is an important regulatory requirement prior to the Company requesting a pre-NDA meeting.