BioDelivery Sciences International, Inc. (Nasdaq: BDSI) and Meda today announced approval of BEMA Fentanyl in Europe via the Decentralized Procedure, with Germany acting as Reference Member State. BEMA Fentanyl is indicated for the management of breakthrough pain in opioid tolerant, adult patients with cancer. National marketing authorization approvals, enabling commercial sales in each of the 25 individual EU countries, are now expected over the next several months. BEMA Fentanyl, which is approved in the U.S. and Canada as ONSOLIS (fentanyl buccal soluble film), will be marketed as BREAKYL (fentanyl buccal film) in Europe.

Under the terms of its licensing agreement with Meda, BDSI receives a milestone payment of $2.5 million triggered by the first national marketing authorization of BREAKYL and another $2.5 million at the time of the first commercial sale that is anticipated sometime prior to the end of 2011. Additionally, BDSI will receive a double-digit royalty on net sales.

“We are very pleased to expand the availability of BEMA Fentanyl to include another significant region of the world,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. “BREAKYL is the first product to be approved in the EU using our BEMA drug delivery technology, and we believe it will provide a novel approach to the treatment of breakthrough pain in opioid tolerant patients. The approval of BREAKYL is the result of a continued strong collaborative effort between BDSI and Meda.”

Anders Lönner, Chief Executive Officer of Meda, added, “We are pleased with this achievement, and we look forward to making BREAKYL available to patients across Europe who are afflicted with this indication. There is a growing medical need and BREAKYL offers a novel and patented delivery technique compared with current treatment alternatives.”

About BioDelivery Sciences International

BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI’s pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the EU (where it is marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI’s second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation for the treatment of opioid dependence. Additional product candidates are being developed utilizing the BEMA technology for conditions such as nausea/vomiting (BEMA Granisetron) and migraine (BEMA “Triptan”). BDSI’s headquarters is located in Raleigh, North Carolina. For more information please visit www.bdsi.com.

BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.

Cautionary Note on Forward-Looking Statements

This press release and the statements of representatives and partners of BioDelivery Sciences International, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “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, results relating to anticipated national marketing authorization approvals and anticipated sales of BREAKYL in the EU or the development of other BEMA product candidates) may differ significantly 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). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.