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”