12 Apr 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Israel-based Oramed Pharmaceuticals, a developer of oral drug delivery systems, submitted a new Investigational New Drug (IND) application to the US FDA for a sub-study on its oral insulin candidate, ORMD-0801.
This filing is in response to FDA feedback from Oramed's initial IND filing on December 31, 2012, wherein the FDA requested the firm to perform a sub-study in a controlled in-patient setting for up to a one-week period prior to beginning the larger multi-centered phase II trial.
Mr Nadav Kidron, CEO, Oramed, said that, "This new IND filing comes after ongoing productive communications with the FDA. We look forward to receiving clearance on this IND and beginning our trials in the US."