BioDelivery Sciences Retains The Investor Relations Group of New York.

MORRISVILLE, N.C. -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI) has retained The Investor Relations Group, Inc. (IRG), based in New York City, to serve as its financial relations and corporate communications firm. IRG's mandate will be to increase investor awareness of BDSI within the U.S. market by introducing the company and its management to pre-qualified investment professionals and both financial and trade publications. The company's retention of IRG is part of its continuing investor relations and communications efforts in the wake of its "follow on" public offering in October 2005.

Dr. Mark A. Sirgo, President and CEO of BDSI, commented, "We made significant progress on our business plan during 2005, and we are now to the point where we need the support of a full-time investor relations firm to assist us in communicating news to our stockholders and to raise the profile of the company within the investment community. We are pleased to have hired IRG to represent us as we continue our evolution into a fully integrated specialty pharmaceutical company."

As previously announced, BDSI submitted a New Drug Application (NDA) on Emezine(R), a dissolving buccal tablet formulation of prochlorperazine maleate for the treatment of severe nausea and vomiting, to the U.S. Food and Drug Administration in April 2005. The FDA has notified BDSI that it will rule on the approvability of the Emezine(R) NDA no later than February 28, 2006.

In addition, BDSI plans on completing its Phase III BEMA(TM) Fentanyl trials during the second half of 2006 for the treatment of "breakthrough" cancer pain. BEMA(TM) Fentanyl is an oral adhesive disc formulation of the narcotic fentanyl. Additionally, BDSI will be conducting Phase I trials with BEMA(TM) LA, its second analgesic in the BEMA(TM) technology, in the first quarter of 2006 and plans to initiate Phase III trials in the second half of 2006.

The Company also announced that, effective today, U.S. investor and media inquiries relating to the company can be directed to The Investor Relations Group, New York, NY, Telephone: [phone], Fax [phone].

About BioDelivery Sciences International, Inc.

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. For more information please visit www.bdsinternational.com.

About The Investor Relations Group, Inc.

The Investor Relations Group, Inc., (IRG) founded in 1996, represents select publicly traded companies, with a unique specialization for assisting those in the small-cap sector. IRG arranges one-on-one meetings for its portfolio companies with pre-qualified money managers handling investment portfolios that range from $10 million to $10 billion+ selected from its proprietary contact base of over 33,000 qualified fund managers who have an investing history in small-cap stocks. IRG is a full-service corporate communications company offering services for its portfolio companies that include writing all press releases and shareholder communications and serving as primary contact for the investing community. IRG also houses a full-service public relations arm that specializes in building awareness of its companies within the financial and trade media, as well as the public at large. For further information, please visit the company's website at www.investorrelationsgroup.com.

Forward-Looking Statements

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).