Citius Pharmaceuticals Inc. (NASDAQ:CTXR) has announced that the FDA has given a positive opinion regarding its proposed plan of studying catheter compatibility for its Mino-Lok Therapy.
Studies to show the application of Mino-Lok in central venous catheters
Once the studies are completed, and they will be successful, they will enable the labeling of Mino-Lok for use with the available peripherally inserted central catheters and central venous catheters in the US market. Equally, there is a presumption that the planned compatibility studies will be within the World and European standards.
The potential of labeling without any restrictions relative to catheter type will allow Mino-Lok to have unrestricted access across the US and globally. It will be an active antibiotic lock treatment for CLABSIs, which is a market estimated to be more than $1.5 billion annually. The company will conduct the catheter compatibility trials in parallel with the current third phase clinical trial. In early February this year, Citius announced that the pivotal study was already halfway in terms of enrolment. The trial’s next milestone will be the result of preliminary efficacy analysis that the company expects to complete in the second half of this year.
Citius on the path to submit NDA for Mino-Lok
The Company’s CEO, Myron Holubiak, indicated that they are on the right path towards meeting the requirements to prompt an NDA submission. He explained that according to the company’s planned recommended dose, the Mino-Lok solution usually stays in the catheter for around 2 hours each day for five to seven days. In aggregate, this will be around 10 to 14 hours but sporadic catheter exposure time to Mino-Lok. Myron added that the exposure is much lower relative to recommended home-made antibiotic solutions.
The CEO concluded that the shorted Mino-Lok dwell time is an indication that the catheter will be available for its anticipated use and therefore allow treatment for the disease to go on. Most importantly, the pivotal study has been designed to demonstrate Mino-Lok’s superiority relative to standard antibiotics locks when it comes to catheter failure.