Citius Pharmaceuticals Reports FDA Type C Meeting for Phase 3 Mino Study
Citius Pharmaceuticals, a biopharmaceutical company focused on critical care products, recently had a successful Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the Phase 3 Mino-Lok® program. This program involves a novel catheter lock solution aimed at helping patients with central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI).
During the meeting, the FDA provided valuable guidance on the clinical trial data for Mino-Lok and outlined a clear pathway towards a future New Drug Application (NDA) submission. The discussions covered various essential topics such as in-vitro data, clinical efficacy, safety data, and regulatory considerations.
Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals, expressed optimism about the FDA’s feedback, emphasizing the potential of Mino-Lok to address a critical medical need and enhance patient outcomes. He highlighted that the treatment could offer substantial cost savings to the healthcare system and improve outcomes for patients requiring central venous catheterization.
Mino-Lok is an antibiotic lock solution that combines minocycline, ethanol, and edetate disodium to treat patients with catheter-related bloodstream infections. It aims to provide an alternative to removing and replacing central venous catheters, potentially reducing adverse events and healthcare costs. If approved, Mino-Lok would be the first FDA-approved treatment to salvage central venous catheters that cause these infections.
In addition to Mino-Lok, Citius Pharmaceuticals recently received FDA approval for LYMPHIR™, a targeted immunotherapy for treating cutaneous T-cell lymphoma. The company’s pipeline also includes CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief. The completion of pivotal trials for Mino-Lok and Halo-Lido in recent years marks significant progress in the company’s commitment to advancing critical care products.
Citius Pharmaceuticals remains dedicated to advancing the Mino-Lok® program and will continue to provide updates on regulatory and clinical developments as they move forward.
