FDA requires company to conduct a sub study before it begins the clinical trial
JERUSALEM, Israel I February 14, 2013 I Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has been in communication with the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application for oral insulin. The FDA has asked Oramed to perform a sub study in a controlled in-patient setting for up to a one-week period. In order to accommodate the FDA’s request, Oramed will submit a new IND with a clinical protocol for the aforementioned sub study.
"We are very pleased to be in close and positive communications with the FDA, as well as having a clear path which meets the FDA’s input. This positions us for imminent clearance from the FDA to proceed with our planned clinical studies," commented Nadav Kidron, CEO of Oramed.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed’s technology is based on over 30 years of research by top research scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently approaching Phase 2 clinical trials under U.S. IND, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), currently approaching Phase 2a trials. The company’s corporate and R&D headquarters are based in Jerusalem.
SOURCE: Oramed Pharmaceuticals
Post Views: 178
FDA requires company to conduct a sub study before it begins the clinical trial
JERUSALEM, Israel I February 14, 2013 I Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has been in communication with the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application for oral insulin. The FDA has asked Oramed to perform a sub study in a controlled in-patient setting for up to a one-week period. In order to accommodate the FDA’s request, Oramed will submit a new IND with a clinical protocol for the aforementioned sub study.
"We are very pleased to be in close and positive communications with the FDA, as well as having a clear path which meets the FDA’s input. This positions us for imminent clearance from the FDA to proceed with our planned clinical studies," commented Nadav Kidron, CEO of Oramed.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed’s technology is based on over 30 years of research by top research scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently approaching Phase 2 clinical trials under U.S. IND, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), currently approaching Phase 2a trials. The company’s corporate and R&D headquarters are based in Jerusalem.
SOURCE: Oramed Pharmaceuticals
Post Views: 178
