CRANFORD, N.J., Dec. 19, 2016 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") (OTC BB: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced that it has assisted the manufacturer of the active ethanol component of Mino-Lok™, in filing a Type II drug master file (DMF) with FDA. Mino-Lok is being developed as an adjunctive therapy for the treatment of catheter-related or central line associated bloodstream infection (CRBSI/CLABSI) in combination with appropriate systemic antibiotic(s), to salvage infected central venous catheters (CVCs), to preserve central venous access, and to avoid the complications and morbidities associated with catheter removal and reinsertion.
A Type II DMF is reserved for products intended for use as active pharmaceutical ingredients, and such products must meet strict FDA manufacturing and testing standards. It was determined that ethanol is an active component of Mino-Lok, not just an excipient. The DMF allows Citius to cross-reference all manufacturing information related to the ethanol production in their regulatory applications associated with Mino-Lok therapy.
Mr. Myron Holubiak, President and CEO stated, "We have learned that the ethanol level is a vital component to the effectiveness of Mino-Lok therapy providing enhanced antimicrobial coverage and potency to the minocycline/EDTA combination. We believe the proper dose of ethanol is a factor that allows for the relatively short 2 hour dwell times for Mino-Lok, and also avoids the coagulopathies that have been reported with higher dose ethanol locks that have previously been tested. The two hour lock times are a significant benefit as this allows the catheter to be used for its intended purpose the remaining 22 hours throughout the day as needed."
There are currently no approved therapies to salvage infected CVCs.
Mino-Lok™ is under investigation and not approved for commercial use.
About Citius Pharmaceuticals, Inc.
Citius is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products with a focus on anti-infectives, cancer care and unique prescription products using innovative, patented or proprietary formulations of previously approved active pharmaceutical ingredients. We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs. By using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements. We focus on developing products that have intellectual property protection and competitive advantages to existing therapeutic approaches. www.citiuspharma.com
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Vice President, Corporate Development
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SOURCE Citius Pharmaceuticals, Inc.