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Citius Receives Positive FDA Feedback on Its Submitted Plan to Study Catheter Compatibility for Mino-Lok® Therapy
- Compatibility plan includes testing representative samples of all commercially available CVCs and PICCs - Plan is designed to be conducted in parallel with
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"- Compatibility plan includes testing representative samples of all commercially available CVCs and PICCs\n - Plan is designed to be conducted in parallel with the completion of the Phase 3 pivotal trial\n - Targeted worldwide market for Mino-Lok® is expected to reach $1.84 billion by 2028\n\n\nCRANFORD, N.J., June 2, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\" or the \"Company\") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has received positive feedback from the Food and Drug Administration (FDA) on its proposed catheter compatibility studies for the Company's Mino-Lok® therapy. The studies, if and when successfully completed, should allow Mino-Lok to be labeled for use with all commercially available central venous catheters (CVCs) and peripherally inserted central catheters (PICCs) on the U.S. market. It is further assumed that these studies will meet European and world standards. \nThe ability to be labeled without restrictions with respect to catheter type would allow Mino-Lok unrestricted access to the full U.S. and world markets for an effective antibiotic lock therapy for central line-associated bloodstream infections (CLABSIs), which are estimated to be over $1.5 billion per year worldwide. The catheter compatibility studies will be conducted in parallel with the completion of the ongoing Phase 3 clinical study. The Company announced in early February 2020 that this pivotal trial had reached the halfway point for enrollment. The next milestone in the trial is the result of an interim efficacy analysis, which is expected to occur in the second half of 2020. \n\"We believe we continue to check all the boxes required for an NDA submission,\" commented Myron Holubiak, Chief Executive Officer of Citius. \"According to our planned dosing recommendations, the Mino-Lok solution dwells in the catheter for two hours per day for 5 to 7 days. This would be between 10 to 14 hours of aggregate, but intermittent, exposure time of the catheter to Mino-Lok. We believe that this exposure is far lower than what is recommended for home-brewed antibiotic lock solutions, which should lead to less intrusive therapy and fewer days on therapy for patients.\" \n\"The shorter dwell time for Mino-Lok also means that the catheter ...