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Citius Pharma Gains Clarity on Mino-Lok's Regulatory Path After FDA Meeting

• Citius Pharmaceuticals reports a productive Type C meeting with the FDA regarding its Mino-Lok program for catheter-related bloodstream infections (CRBSI). • The FDA provided clear and actionable guidance, supporting a potential New Drug Application (NDA) submission for Mino-Lok. • Mino-Lok demonstrated compelling clinical outcomes in a Phase 3 trial, offering a potential alternative to catheter removal and reducing healthcare costs. • Citius Pharma is committed to advancing the Mino-Lok program and will provide updates on regulatory and clinical developments.

Citius Pharmaceuticals (NASDAQ: CTXR) announced positive outcomes from a Type C meeting with the U.S. Food and Drug Administration (FDA) concerning Mino-Lok, a novel catheter lock solution. The discussion focused on data from the successful Phase 3 clinical trial of Mino-Lok, which is designed to salvage central venous catheters in patients with central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI).
The FDA provided constructive guidance, outlining a pathway to support a future New Drug Application (NDA) submission for Mino-Lok. The meeting covered in-vitro data, clinical efficacy and safety data, and regulatory considerations. Citius Pharma aims to address a critical unmet medical need with Mino-Lok.

Mino-Lok's Potential Impact

Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals, stated, "We are highly encouraged by the collaborative and substantive nature of our engagement with the FDA regarding the Mino-Lok program." He added that the FDA's feedback supports the advancement of this solution for patients facing life-threatening complications from catheter-related infections.
Mino-Lok combines minocycline, ethanol, and edetate disodium to treat catheter-related bloodstream infections. Citius licensed Mino-Lok from an affiliate of The University of Texas MD Anderson Cancer Center. The treatment is designed as an alternative to removing and replacing central venous catheters (CVC), potentially reducing adverse events and healthcare costs. If approved, Mino-Lok would be the first FDA-approved treatment to salvage central venous catheters causing central line-related bloodstream infections.

Clinical Trial Outcomes

The Phase 3 trial demonstrated compelling clinical outcomes, supporting Mino-Lok's potential to enhance the management of catheter-related bloodstream infections. As an alternative to catheter removal, Mino-Lok could reduce healthcare costs, mitigate patient risks, and improve clinical outcomes for individuals requiring central venous catheterization.
Citius Pharma remains committed to advancing the Mino-Lok program and will provide updates on regulatory and clinical developments.
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Citius Pharmaceuticals completed a Type C meeting with the FDA to discuss the Phase 3 Mino-Lok program for catheter-related bloodstream infections (CRBSI).
The FDA provided clear and actionable guidance, supporting a potential New Drug Application (NDA) submission for Mino-Lok.

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Reference News

[1]
Citius Pharma Advances Mino-Lok After Successful FDA Meeting, Phase 3 Trial Results
stocktitan.net · Nov 25, 2024

Citius Pharmaceuticals held a constructive FDA meeting to discuss Mino-Lok's Phase 3 trial data and pathway to NDA submi...

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