BioDelivery Sciences International, Inc. has received written notification from the US Food and Drug Administration that its new drug application (NDA) for Emezine has been accepted for review.

Under FDA regulations, the FDA has up to 10 months from the date of NDA submission to review and render a decision on the application as to whether it is approvable or not.

Emezine is a formulation of prochlorperazine, a currently approved agent for the treatment of nausea and vomiting. Emezine is conveniently administered by placing the dissolving tablet between the upper lip and gum, thereby delivering the drug across the membrane of the mouth. To the best of BDSI's knowledge, Emezine, if approved by the FDA, would be the first and only transmucosal medication for nausea and vomiting in the United States, according to a company release.

BDSI believes that Emezine will give physicians a patient-friendly alternative to injections or suppositories for the treatment of nausea and vomiting associated with a wide range of conditions such as surgery, chemotherapy and migraine attacks. BDSI has the exclusive US rights to Emezine under a license agreement with Reckitt Benckiser Healthcare (UK) Limited.

Dr. Mark A. Sirgo, BDSI's president and COO, said: " As we move into the second half of 2005, we hope to continue this trend with our entry into our Phase III program with BEMA Fentanyl and the filing our IND and first human trial for Bioral Amphotercin B."

BioDelivery Sciences’ drug delivery technologies include: the patented Bioral nanocochleate technology, designed for a potentially broad base of applications, and the patented BEMA (transmucosal or mouth) drug delivery technology.