BDSI Submits Two Emezine(R) Pharmacokinetic Study Designs to the FDA Under Special Protocol Assessment; FDA To Review New Study Protocols and Give Guidance on BDSI's Emezine(R) Strategy.

MORRISVILLE, N.C. -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a specialty biopharmaceutical company, has submitted a plan to the United States Food and Drug Administration (FDA) to conduct two clinical pharmacokinetic studies regarding the company's Emezine(R) (prochlorperazine maleate) buccal tablets. This plan was submitted for FDA review in response to the company's previously announced meeting with the FDA regarding Emezine(R).

The company's proposed studies will seek to address specific concerns raised by the FDA relating to Emezine(R). The proposals were submitted under the FDA's Special Protocol Assessment (SPA) guideline as per their recommendation. Under this guideline, the protocol design, endpoints and expected regulatory results would be evaluated by the FDA, and then agreed to with the company, as to whether they are sufficient to meet regulatory expectations for approval, prior to commencing the studies.

As previously announced, at the company's May 17, 2006 meeting with the FDA to discuss their February 2006 non-approvable decision and action letter regarding BDSI's new drug application for Emezine(R), the FDA indicated that they would consider the additional information being requested for Emezine(R) under the context of an SPA. Under this guideline, FDA will evaluate within 45 days the protocols to determine whether they meet scientific and regulatory requirements noted in the non approvable letter and confirmed in the May 17th meeting. If the agency confirms that these protocols meet these requirements for approval BDSI will have the opportunity to proceed.

Dr. Mark A. Sirgo, BDSI's President and CEO, said, "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(R) that avoids the need to conduct a more lengthy and costly clinical efficacy and safety study. 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."

Thomas Shumaker, Director of Regulatory Affairs at BDSI added, "If we receive the FDA's agreement on the protocols through the SPA process, we will have a better idea of the cost and timing for completing these studies, which in turn will allow us make to a final determination on whether or not to proceed with Emezine(R). Based on our experience, we believe that once the new information is obtained and submitted, this data will be reviewed within 6 months by the FDA."

Emezine(R) is an oral transmucosal (drug absorbed directly through the mucosa of the mouth) medication for the treatment of nausea and vomiting. The current alternatives to oral tablets are injections and suppositories. BDSI licenses Emezine(R) on an exclusive basis in the U.S. from Reckitt Benckiser Healthcare (UK) Limited. The Emezine(R) tablets are proposed to be manufactured for BDSI by Reckitt Benckiser, which currently distributes a similar product in the United Kingdom. TEAMM Pharmaceuticals, a subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), has contracted to be BDSI's commercial partner for Emezine(R).

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. is a specialty biopharmaceutical company that is exploiting its licensed and patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, clinically-significant new formulations of proven therapeutics targeted at "acute" treatment opportunities such as pain, anxiety, nausea and vomiting, and infections. The company's drug delivery technologies include: (i) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology and (ii) the patented Bioral(R) nanocochleate technology, designed for a potentially broad base of applications. The company's headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey. For more information please visit www.bdsinternational.com.

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