Citius Pharmaceuticals Achieves Chemical Manufacturing and Control Milestones for Mino-Lok®
CRANFORD, N.J., Sept. 22, 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 achieved a number of significant milestones over the past several weeks for Mino-Lok®.
Mino-Lok is an antibiotic lock solution being developed as an adjunctive therapy for patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). Mino-Lok contains three active drug substances (minocycline, ethanol and EDTA) which are combined into two vials, MLT01 (minocycline) and MLT02 (ethanol and EDTA). Citius has manufactured three registration lots of Mino-Lok using the commercial manufacturing process, which will be filed in the planned New Drug Application (NDA). Citius has placed all registration lots on stability at the appropriate ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) conditions to support the NDA filing. Citius has also developed a new exclusive synthesis process for disodium edetate ("EDTA"), a chelating agent which supplants heparin as the anti-clotting agent in Mino-Lok.
NDAs are applications to request permission to market a drug product in the U.S. for a specific use. Chemistry, manufacturing, and controls (CMC) information is therefore submitted in the NDA to ensure product quality as it relates to the safety and efficacy of the drug product.
"A typical drug approval contains one drug substance, so for all practical purposes our team has developed three products. Mino-Lok is unique in many ways, this being one of them," said Myron Holubiak, Chief Executive Officer of Citius. "It's important to know that we expect to be prepared to immediately move to validation/commercial manufacturing upon the completion of our Phase 3 clinical trial and receiving the required FDA clearance."
About Citius Pharmaceuticals, Inc.
Mino-Lok® is an antibiotic lock solution being developed as an adjunctive therapy in patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). CLABSIs/CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients, for whom venous access presents a challenge. There are currently no approved therapies for salvaging infected CVCs.
SOURCE Citius Pharmaceuticals, Inc.
Company Codes: NASDAQ-SMALL:CTXR