MORRISVILLE, NC — The Food and Drug Administration has rejected approval, at least for the time being, of a drug that
BioDelivery Sciences International
(BDSI) had licensed for sale in the United States.
BDSI (Nasdaq: BDSI) said it received the "non-approvable" letter from the FDA on Tuesday. The FDA said it wanted additional information about Emezine, which BDSI licensed from a British firm. It is for the treatment of severe nausea and vomiting.
The rejection was announced after the markets closed on Wednesday.
Company executives have asked for a meeting with the FDA to discuss its findings.
"We are extremely surprised and disappointed by the FDA's decision in light of the fact that we strictly adhered to the development program that was outlined in our pre-NDA meeting with the FDA in March of 2004," said Mark Sirgo, president and chief executive officer of BDSI, in a statement. "It is clear based on the FDA's comments that they are now, among other things and contrary to our previous expectations, seeking additional data on the product. We will take the next few days, in conjunction with our licensing and distribution partners, to consider our options in responding to and working with the FDA on this matter."
Emezine was licensed from Reckitt Benckiser Healthcare, which is based in the United Kingdom.