Oramed Submits New IND Application for Oral Insulin Trial in the US
Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that it has submitted a new Investigational New Drug (IND) application with the U.S. Food and Drug Administration (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 Oramed 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 2 trial.
"This new IND filing comes after ongoing productive communications with the FDA," stated Nadav Kidron, CEO of Oramed. "We look forward to receiving clearance on this IND and beginning our trials in the US."