BDSI Announces Its Intention to Initiate Phase III Clinical Trials of BEMA Fentanyl.

NEWARK, N.J. & MORRISVILLE, N.C. -- 505(b)(2) Regulatory Pathway to Be Available for BDSI's Formulation of Breakthrough Cancer Pain Medication

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) (NASDAQ:BDSIW) announced today that it has received confirmation from the U.S. Food and Drug Administration that the company will be able to utilize the FDA's 505(b)(2) regulatory pathway for regulatory approval consideration of its licensed BEMA(TM) fentanyl formulation. As a result of this guidance, BDSI stated that it plans to enter BEMA(TM) fentanyl into Phase III clinical studies in the second half of 2005. BDSI is developing BEMA(TM) fentanyl for the treatment of breakthrough pain in cancer patients.

Dr. Mark A. Sirgo, President and Chief Operating Officer of BDSI, stated, "Receiving this guidance from the FDA is an important step as BDSI moves forward in its effort to commercialize BEMA(TM) fentanyl. The development of BEMA(TM) fentanyl is our top corporate priority, and we believe we are on target for the initiation of our Phase III program this year."

Dr. Sirgo continued, "Moreover, this guidance confirms our evolving development and commercialization strategy of using the FDA's 505(b)(2) approval process to obtain more timely and efficient approval of new formulations of previously approved therapeutics, like fentanyl, which incorporate our licensed drug delivery technologies, such as BEMA(TM). Because the 505(b)(2) approval process is designed to address new formulations of previously approved drugs, we believe it has the potential to be more efficient and less time consuming than other FDA approval methods."

BDSI's BEMA(TM) fentanyl is a transmucosal (i.e., absorption through the cheek) formulation of fentanyl, an FDA-approved narcotic pain medication. BDSI believes that the only other approved transmucosal fentanyl product approved for breakthrough pain in cancer patients in the United States is Actiq(TM), a fentanyl "lozenge" marketed by Cephalon. Cephalon recently announced that its 2004 sales of Actiq(TM) were approximately $345 million.

BDSI's fentanyl formulation uses the patented BEMA(TM) technology, originally developed by Atrix Laboratories and exclusively licensed to BDSI in the U.S. through its Arius Pharmaceuticals subsidiary. The BEMA(TM) delivery technology consists of an easy to use, dissolvable, dime-sized polymer disc that is applied to the mucus membrane of the mouth. The disc dissolves over approximately 20-30 minutes, delivering the drug across the mucus membrane for rapid absorption and onset of effect.

BDSI is also using the 505(b)(2) approval pathway for its transmucosally delivered formulation of Emezine(TM), an anti-nausea and vomiting medication. Through its Arius Pharmaceuticals subsidiary, BDSI licenses this dissolving tablet formulation of Emezine(TM) from a third party pharmaceutical company. BDSI recently announced that it anticipates filing a New Drug Application for its formulation of Emezine(TM) with the FDA in the second quarter of this year. This filing will represent a significant milestone for BDSI as it represents the company's first new drug application.

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 is located in Newark, New Jersey, and the company also has operational and administrative 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 (including, without limitation, its initiation of clinical trials and the FDA approval process), 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).

L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remuneration for public relations and or other services in the form of monies, capital stock in the Company, warrants or options to purchase capital in the Company.