WEDNESDAY, SEPTEMBER 28, 2016

Oral insulin candidate awaits FDA research approval

Oramed Pharmaceuticals, Inc., announced on Thursday that it has submitted a new Investigational New Drug application with the FDA for ORMD-0801, an oral insulin candidate.

Oramed initially filed for IND approval with the U.S. Food and Drug Administration on December 31. The FDA responded with a request for Oramed to conduct a sub-study with a controlled in-patient population over the course of a week.

Oramed submitted its request for the sub-study on Thursday. They will need to conduct this study and submit the results to the FDA before being allowed to proceed to the Phase 2 trial, as it is a larger and multi-centered.

"This new IND filing comes after ongoing productive communications with the FDA," Oramed CEO Nadav Kidron said . "We look forward to receiving clearance on this IND and beginning our trials in the U.S."

Founded in 2006, Oramed specializes in the development of oral medication as an alternative to injections. The company uses technology built upon 30 years of research by Jerusalem's Hadassah Medical Center scientists.