Citius Pharma Announce Positive Topline Results For Pivotal Phase 3 Clinical Trial Of Mino-Lok
(RTTNews) - Biopharmaceutical company Citius Pharmaceuticals, Inc. (CTXR) announced Tuesday positive topline results of its pivotal Phase 3 clinical trial of Mino-Lok, a novel antibiotic lock solution designed to salvage catheters in patients with central line-associated infections (CLABSI) or catheter-related bloodstream infections (CRBSI).
The study met its primary endpoint with a statistically significant improvement in the time to failure event in patients receiving Mino-Lok compared to Control arm patients receiving clinician-directed anti-infective lock solution. The data demonstrate that Mino-Lok is well-tolerated.
The company said it looks forward to engage with the US Food and Drug Administration (FDA) to determine the optimal path forward for Mino-Lok, which is expected to offer a much-needed alternative to the current practice of catheter removal and replacement.
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