BDSI Prepares For Phase III with BEMA(TM) Fentanyl Following Positive Results of Comparative Pharmacokinetic Study.

MORRISVILLE, N.C. -- Study Demonstrates BEMA(TM) Fentanyl Has Enhanced Absorption Compared to Market Leader Actiq(R)

BioDelivery Sciences International, Inc. (NASDAQ: BDSI, BDSIW), a specialty pharmaceutical company, today announced the results of a crossover study comparing the pharmacokinetics between equal strengths of BDSI's oral adhesive disc (known as BEMA(TM)) formulation of the narcotic fentanyl and Actiq(R), a lozenge formulation of fentanyl which is the current market leader in fast dissolving fentanyl products in treating breakthrough cancer pain.

The study was conducted in 12 subjects who used both BEMA(TM) Fentanyl and Actiq(R). The results showed that the BEMA(TM) Fentanyl formulation showed greater bioavailability (absorption), higher maximum plasma concentrations (Cmax) and faster concentrations of fentanyl in the plasma (t-first and t-max) compared to Actiq(R).

Actiq(R), produced by Cephalon Inc. (NASDAQ:CEPH), had reported 2004 sales of $345 million and, according to Cephalon's public statements, projected 2005 sales between $390 to $420 million. BDSI has previously disclosed its belief that BEMA(TM) Fentanyl could potentially achieve annual peak sales of approximately $250 million for the company.

Dr. Andrew Finn, Executive Vice President of Clinical and Regulatory Development for BDSI, stated "Simply put, the results of this study demonstrate that fentanyl can potentially be delivered more effectively and easily from BDSI's BEMA(TM) delivery system compared to Actiq(R). Besides allowing greater absorption of fentanyl, this study demonstrated that the BEMA(TM) disc was easier to use for the subjects in the study as it only required seconds to apply while the Actiq(R) lozenge required active sucking for up to 30 minutes."

BDSI reported in July 2005 that it had signed a $7 million dollar licensing and development agreement with Princeton, New Jersey based Clinical Development Capital, LLC (CDC) under which CDC, will provide up to $7 million dollars in funding for BDSI's Phase III program for BEMA(TM) Fentanyl provided certain conditions are met. BDSI has previously reported that it plans to initiate its Phase III BEMA(TM) Fentanyl program for the treatment of "breakthrough" cancer pain prior to the end of 2005.

Dr. Francois Nader, Chief Medical Officer at Clinical Development Capital, stated that "The results of this study continue to indicate a profile of BEMA(TM) Fentanyl that will make it an effective and valuable therapy for the treatment of breakthrough cancer pain and demonstrates BDSI's ability to execute their development plan."

Dr. Mark A. Sirgo, President and CEO of BDSI stated "We believe that the data from this trial represents another significant milestone for BDSI. These results bolster our confidence that, if approved by the FDA in the future, BEMA(TM) Fentanyl has the potential to be a significant product for the management of breakthrough cancer pain. Moreover, the results further demonstrate the potential viability of the BEMA(TM) drug delivery platform as a whole. We look forward to now commencing our Phase III program for BEMA Fentanyl."

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 Bioral(R) nanocochleate technology, designed for a potentially broad base of applications, and (ii) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology. The company's headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey.

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, including, without limitation, the results of additional clinical trials and FDA review of the Company's formulations and products, 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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