Citius Pharmaceuticals Update on FDA Type C Meeting for Phase 3 Minocycline Study
Citius Pharmaceuticals recently shared exciting news about a successful meeting with the FDA. The company, devoted to developing and bringing innovative critical care products to the market, met with the U.S. Food and Drug Administration to discuss the Phase 3 clinical trial of Mino-Lok®, a unique catheter lock solution for patients with central line-associated bloodstream infections.
During the meeting, the FDA provided clear guidance and actionable feedback, highlighting a potential pathway for a future New Drug Application (NDA) submission for Mino-Lok. The discussions covered crucial topics like clinical trial data, safety, and regulatory considerations. Citius Pharmaceuticals is optimistic about the potential of Mino-Lok to address a significant medical need and is committed to further advancing the program.
Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals, expressed enthusiasm about the collaboration with the FDA, emphasizing the support and guidance received. The positive outcomes seen in the Phase 3 trial of Mino-Lok demonstrate its ability to significantly improve the management of catheter-related bloodstream infections, potentially reducing healthcare costs and improving patient outcomes.
Mino-Lok is a novel antibiotic lock solution developed to treat patients with catheter-related bloodstream infections, offering an alternative to catheter removal. If approved, Mino-Lok could be the first FDA-approved treatment to salvage central venous catheters causing such infections.
Citius Pharmaceuticals is dedicated to bringing innovative solutions to patients in critical care situations. In addition to Mino-Lok, the company’s pipeline includes LYMPHIR™, a targeted immunotherapy for the treatment of cutaneous T-cell lymphoma, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief. The completion of pivotal trials for Mino-Lok and Halo-Lido marks significant progress in the company’s commitment to developing effective critical care products. As the program advances, Citius Pharmaceuticals will continue to provide updates on regulatory and clinical developments.
