BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that
the company has been granted a meeting with the U.S. Food and Drug
Administration (FDA) to discuss the planned Investigational New Drug
(IND) application for BDSI’s antiemetic (anti-nausea and vomiting)
product candidate, BEMA Granisetron. The meeting will take place on
March 17, 2010. The company will discuss with the FDA clinical
development and regulatory plans for BEMA Granisetron, which is
anticipated to enter Phase 1 studies in the second quarter of 2010.
“Patients experiencing nausea and vomiting often have difficulty taking
oral medications. Additionally, absorption of drug from the
gastrointestinal tract can be highly variable in these individuals”
“Patients experiencing nausea and vomiting often have difficulty taking
oral medications. Additionally, absorption of drug from the
gastrointestinal tract can be highly variable in these individuals,”
said Dr. Andrew Finn, Executive Vice President, Product Development at
BDSI. “Having a formulation of an antiemetic that does not require
swallowing and gastric absorption could possibly lead to faster and more
consistent blood levels of drug. We believe that such a product could
have significant potential.”