BDSI Completes Clinical Trials for its Formulation of Emezine.

NEWARK, N.J. & MORRISVILLE, N.C. -- - First Drug to be Delivered Transbucally for Rapid Treatment of Nausea and Vomiting 

- Filing of New Drug Application for Buccal Delivery Formulation Anticipated in 2Q 2005

BioDelivery Sciences International, Inc. (Nasdaq:BDSI) (Nasdaq:BDSIW) announced today that it has completed the clinical studies required for its pending New Drug Application (NDA) on Emezine(TM), a buccal product for the treatment of nausea and vomiting. Emezine(TM) will be the first product in the U.S. market for the treatment of nausea and vomiting to be provided via a buccal (i.e., across the cheek membrane) delivery system. BDSI, through its Arius Pharmaceuticals subsidiary, licenses Emezine(TM) from a third party pharmaceutical company.

BDSI's Emezine(TM) product is administered by placing a tablet between the gum and the cheek where it dissolves, enabling the active ingredient to be absorbed through the lining of the cheek. This formulation provides for a rapid onset of action and an alternative to swallowed tablets, suppositories or injections. BDSI believes that delivering an anti-nausea drug transbuccally may offer advantages over traditional delivery methods.

"It is difficult for many nauseated patients to swallow oral medications, and many patients dislike injections and suppositories. Our Emezine(TM) formulation offers an alternative to these patients because it dissolves in the mouth itself," said Dr. Mark Sirgo, President and Chief Operating Officer of BDSI. "We anticipate filing the NDA for buccally-delivered Emezine(TM) with the Food and Drug Administration early in the second quarter of this year. This filing will represent a significant milestone for BDSI as it represents our first new drug application."

Many patients suffer from nausea and vomiting, either post-operatively as a result of anesthesia or other medications, or, in the case of cancer patients, as a result of chemotherapy. With the incidence of cancer and surgeries on the rise, this market continues to grow. BDSI estimates that the U.S. market for anti-emetics (i.e., anti-nausea medications) is approximately $2 billion dollars.

BDSI has previously entered into an agreement with a third party to commercialize buccal Emezine(TM) in the United States, in exchange for milestone payments and a royalty on sales. BDSI will pay a portion of this royalty to the company from whom it licenses Emezine(TM).

BioDelivery Sciences International, Inc. is a specialty biopharmaceutical company that is exploiting its licensed and partner-owned patented drug delivery technologies to develop and commercialize clinically-significant new formulations of proven therapeutics, nutraceuticals and micronutrients. The company's drug delivery technologies include: (i) the patented Bioral(TM) nanocochleate technology, designed for a potentially broad base of applications, and (ii) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology being developed by the company's Arius Pharmaceuticals subsidiary. Arius is developing products for the "acute" treatment opportunities such as pain, anxiety, nausea and vomiting, and infections. The company's principal laboratory and offices are located in Newark, New Jersey, and the company also has offices in Morrisville, North Carolina.

Note: Except for the historical information contained herein, this press release contains, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. Such statement may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control).

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