Neutrolin

Neutrolin® is a non-antibiotic anti-infective developed as a preventative solution to decrease the threat of infection and blood clots (thrombosis), thereby keeping central venous catheters (CVCs) operating safely and efficiently.  Neutrolin is approved as a CE Marked medical device in Europe where, in post-market studies, it was shown to reduce catheter-related bloodstream infections by 96% and thrombosis by 96.7% compared to historical benchmarks.  In the United States, where Neutrolin is not yet approved, the product is regulated as a drug and is in Phase 3 clinical development.

Neutrolin is a proprietary formulation of taurolidine 1.35%, citrate 3.5% and heparin 1000 units/mL that is used to fill catheter lumens when they are not in use, keeping them sterile and preventing blood clots (thrombosis).  Taurolidine, the key compound in Neutrolin, is an amino acid derivative with broad antimicrobial activity against gram-positive and gram-negative bacteria, including antibiotic resistant strains, as well as mycobacteria and clinically relevant fungi including Aspergillus.

Neutrolin may ultimately benefit adult and pediatric patients with long-term CVCs and peripherally inserted central catheters (“PICCs”). These patients include: those undergoing hemodialysis (a form of dialysis where the patient’s blood is circulated through a dialysis filter), receiving chemotherapy and basic fluids, long term antibiotic therapy, parenteral nutrition (complete or partial dietary support via intravenous nutrients) and those receiving acute treatment in the intensive/critical care unit.

A post-market clinical utility study evaluated the use of Neutrolin in the prevention of catheter-related blood infections (CRBSIs) and thrombosis. Under the study, 202 hemodialysis patients at 20 hemodialysis centers in Germany were enrolled in the ongoing Neutrolin Use Monitoring Program (NUMP), representing 15,464 dialysis sessions over a 26-month period, for a total of 36,083 hemodialysis catheter days. These data demonstrated that use of Neutrolin is associated with 96.0% reduction in the rate of CRBSI and 96.7% reduction in thrombosis compared to published historical benchmarks of 3.5 CRBSIs and 2-3 episodes of thrombosis per 1,000 catheter days. No significant adverse drug reactions that led to the discontinuation of Neutrolin use were reported. Real world data from the Neutrolin Use Monitoring Program also indicated that Neutrolin:

  • Helps prevent inflammatory complications, which are a primary cause of morbidity among end-stage renal disease hemodialysis patients
  • Reduces the need for local and systemic antibiotics, which can increase microbial resistance and infection risks
  • Reduces the likelihood of catheter failures
  • Prolongs catheter life, thus reducing the need for reinsertion procedures
  • Reduces hospital lengths of stays

Target Market

Every day with a CVC presents a risk for an infection to develop.  There are 250,000 CRBSIs in the U.S. per year, which are also referred to as central line-associated bloodstream infections (CLABSI).  Along with thrombosis, these key complications can lead to treatment delays and increased costs to the healthcare system, and higher mortality rates.

Treatment Patients (U.S.) Annual Catheter Days
Hemodialysis 468,000 127,000,000
Oncology/TPN 7,740,000 90,000,000
ICU 5,700,000 28,500,000

A peer-reviewed study analyzed hospitalized patients who had an Intensive Care Unit stay during which a CVC was placed.  In this study, development of CRBSI was associated with significantly longer hospital stay (+7 days), an additional $129 000 in costs for the hospitalization, and greater than 3-fold increase in risk of in-hospital death.  These clinical and pharmacoeconomic factors highlight the need for products that can prevent CRBSI.

Neutrolin in the United States

Neutrolin is currently in a Phase 3 clinical study, known as LOCK-IT-100, to prevent CRBSI in patients with permanent CVCs for vascular access for hemodialysis.

Currently, there are no pharmacological agents approved in the United States for the prevention of CRBSIs.  In January 2015, the U.S. Food and Drug Administration (FDA) granted Fast Track and Qualified Infectious Disease Product (QIDP) designations for Neutrolin.

The Fast Track designation provides CorMedix with the opportunity to meet with the FDA on a more frequent basis during the review process, and also ensures an expedited review of any marketing application.

QIDP designation is assigned to drug products intended to treat serious or life-threatening infections. Neutrolin has shown antimicrobial activity against many such pathogens, are known to cause bloodstream infections in hemodialysis, oncology, and intensive care patients. Importantly, QIDP designation provides an additional five years of market exclusivity in addition to the five years granted for a New Chemical Entity.

Neutrolin in Europe

Neutrolin has CE mark approval for use in the European Union for hemodialysis using a tunneled central vein catheter and use in oncology patients receiving chemotherapy, hydration and medications via central venous catheters. The CE Marking also covers patients receiving medication and fluids via central venous catheters in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). Neutrolin also has CE Marking for total parenteral, or IV, nutrition. For more information about Neutrolin and availability in the European Union, visit CorMedix Europe.