BEMA Granisetron development program: BDSI announces positive meeting with FDA

Mar 22 2010

BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced the positive outcome of a meeting with the FDA on the development program for BEMA Granisetron, the company’s potential treatment for the prevention of nausea and vomiting associated with cancer therapy. FDA concurred with BDSI’s plans to pursue a development program based on clinical pharmacokinetic data for a 505(b)(2) New Drug Application (NDA). If the development program proceeds as anticipated, a BEMA Granisetron NDA could be submitted to the FDA by the end of next year and without the need for clinical efficacy studies.

“We believe that the ability to administer granisetron using the BEMA drug delivery technology may offer patients a means to prevent cancer therapy induced nausea and vomiting without the need to swallow oral tablets or receive an intravenous injection. Buccal delivery may also provide more predictable absorption of the drug”

“We believe that the ability to administer granisetron using the BEMA drug delivery technology may offer patients a means to prevent cancer therapy induced nausea and vomiting without the need to swallow oral tablets or receive an intravenous injection. Buccal delivery may also provide more predictable absorption of the drug,” said Dr. Andrew Finn, Executive Vice President of Product Development for BDSI. “We will conduct Phase 1 studies looking at the absorption of granisetron from the BEMA drug delivery technology, and if plasma concentrations are in the target range, FDA supports our plan to submit the NDA for review without the need for any Phase 2 or Phase 3 clinical trials. This will allow us to save a significant amount of time and money and could potentially allow us to submit an NDA by late next year.”

BEMA Granisetron will utilize the BioErodible MucoAdhesive (BEMA) drug delivery technology to administer the 5HT-3 antagonist granisetron, which is currently marketed in oral and intravenous formulations as Kytril (Genentech). If ultimately approved by FDA, BEMA Granisetron would provide BDSI with an entry into the $1.7 billion antiemetic market and would represent BDSI’s second product for individuals with cancer and the healthcare professionals that treat them.