Plus   Neg

CorMedix : IND For Neutrolin Submitted To FDA - Quick Facts

CorMedix Inc. (CRMD) said that an Investigational New Drug application or IND for Neutrolin was submitted to the United States Food and Drug Administration or 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-center, randomized, controlled study conducted in the U.S. and Europe.

Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin Phase 3 program. 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.

Antony Pfaffle, Chief Scientific Officer at CorMedix said, "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."

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
CVS Health Corp. is hiring 15,000 employees across the U.S. in the fourth quarter to better equip them to tackle the anticipated rise in COVID-19 and flu incidences during the fall and winter months. This is in addition to the recruitment announced in March to fill 50,000 new full-time, part-time and temporary roles across the country in support of the company's response to the pandemic. Ireland's Data Protection Commissioner or DPC, the European Union's main data privacy regulator, is investigating Facebook over its handling of millions of children's personal data on Instagram, reports said. The agency has started two separate inquiries regarding information that email addresses and phone numbers of users under 18 were made public by the Facebook-owned app. ConocoPhillips (COP) and Concho Resources (CXO) announced Monday that they have entered into a definitive agreement to combine companies in an all-stock transaction valued at $9.7 billion. The transaction creates a company with an approximately $60 billion enterprise value and a combined resource...
Follow RTT