FDA meeting on BEMA Granisetron due on March 17 (Nasdaq:BDSI)

BEMA Granisetron is a product candidate that has been developed by BioDelivery Services International, Inc. (Nasdaq:BDSI). According to the company, this product can reduce vomiting and nausea. The company is planning to start the Phase 1 trial of this product as early April 2010. The trial would measure the safety and the effectiveness of BEMA Granisetron in reducing vomiting and nausea. However, before starting the trial, it must get approval from the Food and Drug Administration (FDA) of the United States of America, where it plans to conduct the trial. For this purpose, the company is planning to submit an investigational New Drug (IND) application to the FDA. In order to make sure that the IND application contains all the relevant information and that the Phase 1 trial is conducted properly, the company wants to hold a meeting with officials from the FDA. At present, the FDA has agreed to such a meeting, which is expected to be on March 17, 2010.

BEMA Granisetron uses the company’s “BioErodible MucoAdhesive (BEMA) drug delivery technology”. This is made up of a series of tiny films made of soluble polymer that can give out granisetron, a 5HT3 receptor antagonist, right on to the internal tissues of the cheeks.

The meeting with the FDA is also going to make it easier for the company to plan when it is going to conduct its Phase 3 trial. If the meeting discussion is favorable, the company may start the Phase 3 trial in January 2011.

Nausea and vomiting are common side effects caused by exposure to chemotherapy or other types of radiation. As a result, many cancer patients – who need regular chemotherapy treatments – may stop their treatments in order to avoid the side effects. BEMA Granisetron addresses such problems of these patients.

Dr. Andrew Finn, who is Executive VP of the Product Development department of BioDelivery Services, said ,

“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. 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.”