BioDelivery Sciences submits Emezine pharmacokinetic study designs to the FDA

By Lisa Kerner

Charlotte, N.C., July 17 - BioDelivery Sciences International, Inc. said it submitted two study plans to the Food and Drug Administration under a Special Protocol Assessment for clinical pharmacokinetic studies of its Emezine (prochlorperazine maleate) buccal tablets for the treatment of nausea and vomiting.

"The FDA reaffirmed at the May 17, 2006 meeting that a pharmacokinetic pathway to approval under the 505(b)(2) regulations was still a viable way forward for Emezine that avoids the need to conduct a more lengthy and costly clinical efficacy and safety study," president and chief executive officer Mark A. Sirgo said in a company news release.

"We believe that these two pharmacokinetic study designs will likely address all of the specific concerns expressed by the FDA in the February letter and at the May meeting."

BioDelivery is a specialty biopharmaceutical company located in Morrisville, N.C.

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