BioDelivery Sciences International To Review Strategy for Nausea Drug
Posted June 9, 2006
MORRISVILLE, N.C. — BioDelivery Sciences
International is reviewing its strategy for the future of a nausea drug that the Food and Drug Administration rejected for marketing in the U.S. in February.
BDSI (Nasdaq: BDSI) licensed the drug Emezine from Reckitt Benckiser Healthcare in the United Kingdom. A similar product is sold in the U.K. The drug, which is absorbed through the mouth, is an alternative to injections and suppositories.
The FDA had requested more information from BSDI, leading to a meeting in May.
"At such meeting, BDSI and the FDA agreed in principle on an approach for BDSI to potentially achieve regulatory approval of Emezine," the company said in a statement.
Mark Sirgo, chief executive officer of BDSI, said the company must now decide whether to proceed.
"Although our contention was that the FDA's remaining issues with our data could be managed with product labeling, we believe we have come to an agreement over a pathway forward that is achievable," Sirgo said. "The details of the studies will of course need to be confirmed with the FDA, after which we will determine the costs of the studies and the time to complete them. It will be at that this point when we can fully consider our options as it relates to proceeding forward."