CorMedix, a pharmaceutical company focussed on developing and commercialising therapeutic products for the prevention and treatment of cardiac, renal and infectious disease, announced that an Investigational New Drug application (IND) for Neutrolin was submitted to the United States Food and Drug Administration (US FDA) on September 24, 2014.
The IND includes a pivotal phase 3 protocol for Neutrolin in hemodialysis patients with a central venous catheter. The phase 3 clinical trial is designed as a multi-centre, randomised, controlled study conducted in the US and Europe. Dr. Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin phase 3 programme. An IND goes into effect 30 days after FDA receives the IND, unless FDA provides notification that the IND is subject to a clinical hold.
Dr. Antony Pfaffle, chief scientific officer at CorMedix stated, "The filing of our IND is an important incremental step that we believe will lead to the availability of Neutrolin for patients in the US with central venous catheters. Neutrolin is being developed to help prevent catheter-related infections and thrombosis. The active anti-infective ingredient in Neutrolin is taurolidine, which has efficacy against both common and resistant forms of bacteria and fungi. Use of taurolidine has not been associated with the development of microbial resistance in humans.”
Randy Milby, chief executive officer, of CorMedix would like to thank all the members of the regulatory team, and the scientific advisors who have helped prepare the IND, and wishes to express the company's appreciation to the FDA for its continued guidance in this important regulatory milestone for CorMedix.
Recently CorMedix reported the receipt of a broad label expansion in the entire European Union to include not only hemodialysis catheters, but also catheters used in chemotherapy, total parenteral nutrition and critical care settings. CorMedix is proud to continue to support Neutrolin development and hopes to gain FDA approval to introduce the product in the US to prevent catheter-related infections and thrombosis.