Posted by Michael Wonder on 01 Nov 2017
Citius Pharmaceuticals receives fast track designation by FDA For Mino-Lok investigational trial
31 October 2017 - Citius Pharmaceuticals announced today it has received official notice from the U. S. FDA that the investigational program for Mino-Lok is designated fast track.
Mino-Lok is a catheter lock solution that has entered phase 3 trials for an adjunctive treatment for catheter related blood stream infection (CRBSI).
There are currently no approved therapies to salvage infected central venous catheters, a potential $750 million sector in the US alone. CRBSIs are responsible for mortality rates up to 25% in some patients, and contribute to significant morbidities. Citius is currently starting up sites for a phase 3 trial of Mino-Lok in the United States.
