CRANFORD, N.J., Nov. 25, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that the Company held a constructive in-person Type C meeting with the U.S. Food and Drug Administration (FDA). The meeting followed successful completion of the Company's pivotal Phase 3 clinical trial of Mino-Lok, a novel catheter lock solution designed to salvage central venous catheters in patients suffering from central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI). The primary discussion centered on responses to the FDA's questions related to Mino-Lok's clinical trial data and a pathway to a future submission.
The FDA provided clear, constructive, and actionable guidance during the discussion, underscoring a pathway to support a future New Drug Application (NDA) submission for Mino-Lok. The meeting encompassed an extensive range of topics critical to the NDA process, including in-vitro, clinical efficacy and safety data, and regulatory considerations. Citius Pharma reaffirmed the potential of Mino-Lok to address a critical unmet medical need and its commitment to advancing the program.
"We are highly encouraged by the collaborative and substantive nature of our engagement with the FDA regarding the Mino-Lok program," stated Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals. "The FDA's comprehensive feedback supports our commitment to advancing this novel solution for patients who face life-threatening complications from catheter-related infections. The Agency's guidance provides a strong framework for completing the remaining steps toward an NDA submission."
"We believe Mino-Lok has demonstrated compelling clinical outcomes in the Phase 3 trial, supporting its potential to significantly enhance the management of catheter-related bloodstream infections. As a groundbreaking alternative to catheter removal, Mino-Lok, if approved, could reduce healthcare costs, mitigate patient risks, and improve clinical outcomes for individuals requiring central venous catheterization. Citius Pharmaceuticals remains committed to advancing the Mino-Lok program and will continue to provide updates on regulatory and clinical developments as they unfold," added Mazur.
About Mino-Lok
Mino-Lok is a novel antibiotic lock solution that combines minocycline, ethanol with edetate disodium designed to treat patients with catheter-related blood stream infections. Citius licensed Mino-Lok from an affiliate of The University of Texas MD Anderson Cancer Center. Mino-Lok is designed to offer an alternative to removing and replacing a central venous catheter (CVC), which may lead to a reduction in serious adverse events and cost savings to the healthcare system. If approved, Mino-Lok would be the first and only FDA-approved treatment that salvages central venous catheters that cause central line-related blood stream infections.
About Citius Pharmaceuticals, Inc.
Citius Pharma is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage pipeline also includes Mino-Lok, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs.
