Citius Pharmaceuticals has announced a productive Type C meeting with the FDA regarding its Phase 3 clinical trial of Mino-Lok, a novel catheter lock solution for central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI). The meeting focused on the FDA's feedback on Mino-Lok's clinical trial data and the pathway to a potential New Drug Application (NDA) submission.
FDA Provides Clear Guidance
The FDA provided clear, constructive, and actionable guidance, underscoring a pathway to support a future NDA submission for Mino-Lok. The discussion encompassed a range of topics critical to the NDA process, including in-vitro, clinical efficacy and safety data, and regulatory considerations. Citius Pharma reaffirmed Mino-Lok's potential to address a critical unmet medical need and its commitment to advancing the program.
Mino-Lok: A Novel Approach to CLABSI
Mino-Lok is an antibiotic lock solution that combines minocycline, ethanol, and edetate disodium. It is designed to treat patients with catheter-related bloodstream infections. Citius licensed Mino-Lok from an affiliate of The University of Texas MD Anderson Cancer Center. Mino-Lok is designed as an alternative to removing and replacing a central venous catheter (CVC), potentially reducing serious adverse events and healthcare system costs. If approved, Mino-Lok would be the first FDA-approved treatment to salvage central venous catheters that cause central line-related bloodstream infections.
Clinical and Economic Impact
Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals, stated, "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."
