Citius Pharmaceuticals Engages in Constructive FDA Meeting for Mino-Lok Approval Process

Citius Pharmaceuticals Supports Mino-Lok Pathway with FDA Meeting

Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a biopharmaceutical company focusing on critical care products, has recently reported a productive Type C meeting with the U.S. Food and Drug Administration (FDA). This meeting marks a significant development in the approval process for Mino-Lok®, an innovative catheter lock solution designed to treat patients with catheter-related bloodstream infections (CRBSIs) or central line-associated bloodstream infections (CLABSIs).

Following the successful completion of a pivotal Phase 3 clinical trial for Mino-Lok, the meeting aimed to address the FDA's inquiries regarding the clinical trial data and the pathway to a future New Drug Application (NDA) submission. During this engagement, the FDA provided actionable feedback, clarifying critical aspects related to the NDA process, including in-vitro studies, clinical efficacy, safety data, and essential regulatory considerations.

Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals, expressed optimism about the collaborative nature of the meeting, stating, "We are highly encouraged by the collaborative and substantive nature of our engagement with the FDA regarding the Mino-Lok program. The FDA's comprehensive feedback supports our commitment to advancing this novel solution for patients who face life-threatening complications from catheter-related infections."

Citius Pharma remains dedicated to addressing unmet medical needs within the critical care space. The company highlighted the potential of Mino-Lok to provide significant benefits to patients requiring central venous catheterization. In particular, Mino-Lok is poised to serve as a groundbreaking alternative to traditional catheter removal, which often leads to increased patient risks and healthcare costs. If approved, Mino-Lok would become the first FDA-approved treatment specifically designed to salvage central venous catheters that lead to these severe infections.

About Mino-Lok®: Mino-Lok is an antibiotic lock solution that consists of minocycline, ethanol, and edetate disodium. It aims to treat patients suffering from bloodstream infections while preserving the central venous catheter (CVC) functionality. Citius Pharmaceuticals licensed Mino-Lok from a prominent affiliate of the University of Texas MD Anderson Cancer Center, enhancing its portfolio of first-in-class critical care products.

The meeting not only recognized the successful outcomes of Mino-Lok's Phase 3 clinical trial but also emphasized Citius Pharma's commitment to continuing communication with the FDA as the program advances. The clinical data from the trial demonstrated compelling results, reinforcing its potential for significantly improving the management of catheter-related bloodstream infections.

With a robust late-stage pipeline, Citius Pharmaceuticals is also engaged in the development of other promising products, including LYMPHIR™, currently approved for treating cutaneous T-cell lymphoma, and CITI-002, aimed at relieving hemorrhoids. As they continue this journey, Citius Pharma will keep stakeholders updated on further regulatory and clinical developments.

In summary, Citius Pharmaceuticals' recent meeting with the FDA marks a pivotal step towards advancing the Mino-Lok program. The combination of innovative treatment options and collaborative dialogue with regulatory authorities positions Citius Pharma as a leader in developing solutions for critical healthcare challenges. Stakeholders and patients alike remain hopeful for the future possibilities that Mino-Lok could bring in improving clinical outcomes and reducing burdens associated with catheter-related infections.