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Wednesday 07 December 2005

New Study Shows BDSI's Emezine(R) Demonstrates More Efficient Absorption Versus Swallowed Form of Prochlorperazine

By: HSMN NewsFeed

BioDelivery Sciences International, Inc. (NASDAQ:BDSI , BDSIW ) announced today the publication of a pharmacokinetic (PK) study regarding EmezineŽ, its investigational buccal tablet formulation of prochlorperazine maleate for the treatment of severe nausea and vomiting.

 The findings, published in the December 2005 issue of the Journal of Clinical Pharmacology, showed that, in the PK study, plasma concentrations of EmezineŽ's active ingredient, prochlorperazine, were more than twice as high and less variable than those obtained from a standard oral tablet. EmezineŽ, a dissolving tablet placed between the lip and gum (also known as the buccal area), avoids the need for a patient to swallow a product during a period of nausea and, BDSI believes, offers a more patient-friendly alternative to injections and rectal suppositories.

As previously announced, BDSI submitted a New Drug Application (NDA) on EmezineŽ to the Food and Drug Administration in April 2005. The FDA has notified BDSI that it will rule on the approvability of the EmezineŽ NDA no later than February 28, 2006. Prochlorperazine in other dosage forms is already FDA-approved for the treatment of severe nausea and vomiting. This includes, but is not limited to, post-operative nausea and vomiting and nausea and vomiting associated with chemotherapy, as well as viral infections such as flu. Consistent with its business strategy, BDSI submitted EmezineŽ for FDA review, and the FDA is undertaking such review, via the FDA's 505(b)(2) regulatory approval process, which permits a company to partially rely on the clinical and non-clinical testing results of previously approved pharmaceuticals in connection with the filing by such companies of NDAs with the FDA.

Dr. Andrew Finn, Pharm.D., Executive Vice President of Clinical Development and Regulatory Affairs of BDSI and an author of the study, said "Prochlorperazine has been widely used for many years for the relief of nausea associated with surgery, narcotic use and cancer treatment, including radiation. Our study in normal volunteers demonstrates the variability of oral prochlorperazine absorption, a situation that is likely even greater in the nauseated patient because of the associated delay in the movement of stomach contents and absorption of a drug that is swallowed orally. The buccal delivery of prochlorperazine with EmezineŽ addresses these fundamental absorption issues because it is absorbed through the buccal mucosa in the mouth and is not swallowed."

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