Oramed Pharmaceuticals Inc. a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug application(IND) for ORMD-0801, its oral insulin capsule.
“We are very pleased to have the FDA clearance to proceed,” stated Nadav Kidron, CEO of Oramed. “The upcoming trial is a major milestone for Oramed and we look forward to continuing to progress ORMD-0801’s clinical development in the US.”
Oramed’s ORMD-0801 is an orally ingestible insulin capsule indicated for the early stages of type 2 diabetes, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and allowing pancreatic respite. Moreover, orally administered insulin has the potential benefit of enhanced patient compliance at this crucial stage as well as the advantage of mimicking insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.