Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, has submitted a pre-Investigational New Drug (pre-IND) package to the US Food and Drug Administration (FDA) for ORMD-0901, an orally administered exenatide capsule. Oramed's pre-IND package submission follows its recently announced meeting request letter submitted to the FDA.
The submitted pre-IND package provides the FDA with information on Oramed's ORMD-0901 research conducted to-date, as well as a clinical trial outline for a proposed US clinical trial. The FDA's response to the pre-IND package will serve as a guide to the Company for product development and preparation of a full IND application.
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection.