Kitov Pharmaceuticals Holdings Ltd. Announced that its lead drug candidate KIT-302 met the U.S. Food and Drug Administration's (FDA) standards for establishing six months stability.
The study, conducted by Kitov's manufacturing partner, Dexcel Pharma, demonstrated that nine pivotal batches of KIT-302, three in each dosage forms (celecoxib/amlodipine of 200 mg/10 mg, 200 mg/5 mg, and 200 mg/2.5 mg) met the criteria demonstrating stability for 6 months. The successful stability study enables registration batches of KIT-302 to be included in the New Drug Application (NDA) submission which is planned during Q1 2017.
The Certificate of Analysis demonstrated adequate stability required for submission, in accordance with FDA guidelines. Kitov expects to submit additional stability data to the FDA at a later time, in order to extend the labeled shelf life.
"We are very pleased with the stability study results, which we believe complete the testing required for our New Drug Application to the FDA for KIT-302," stated Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.
