BioDelivery Sciences International, Inc. (Nasdaq: BDSI) will visit the NASDAQ MarketSite in New York City to celebrate the recent FDA approval and upcoming launch of ONSOLIS (fentanyl buccal soluble film).

In honor of the occasion, Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI, and BDSI’s management team will preside over The NASDAQ Stock Market Opening Bell. The event will be held on Friday, October 9, 2009 from 9:15 to 9:30 a.m. EDT at the NASDAQ MarketSite broadcast studio, 4 Times Square (43rd Street and Broadway).

ONSOLIS, formerly referred to as BEMA Fentanyl, was approved by the FDA on July 16, 2009 for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. ONSOLIS is the first product to utilize the company’s proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa (inner lining of the cheek). ONSOLIS utilizes the BEMA technology to deliver the opioid fentanyl. ONSOLIS will be commercialized in the U.S. by Meda Pharmaceuticals, the U.S. subsidiary of Meda AB, a leading international specialty pharmaceutical company.

“We are absolutely delighted to be in New York at The NASDAQ Stock Market for this auspicious occasion,” said Dr. Sirgo. “The FDA approval and upcoming launch of ONSOLIS are milestones that we, along with our commercial partner Meda, have worked diligently toward, and we can think of no better way to celebrate these achievements with our investors than to, quite literally, ring in the good news.”

For additional information on BDSI, please visit www.biodeliverysciences.com or http://irgnews.com/coi/BDSI where you can find company fact sheets, investor materials, and other information.

Feed Information

The Opening Bell is available from 9:20 a.m. to 9:35 a.m. on Galaxy 19 C/15, downlink frequency 4000 vertical. The feed can also be found on Ascent fiber 1623. If you have any questions, please contact Robert Madden at (646) 441-5045.

Radio Feed

An audio transmission of the Opening Bell is also available from 9:20 a.m. to 9:35 a.m. on uplink IA6 C band / transponder 24, downlink frequency 4180 horizontal. The feed can be found on Ascent fiber 1623 as well.

Facebook and Twitter

For multimedia features such as exclusive content, photo postings, status updates, and video of bell ceremonies please visit the following Facebook page:

http://www.facebook.com/pages/NASDAQ-OMX/108167527653

For news tweets, please visit the following Twitter page:

http://twitter.com/nasdaqomx

Webcast

A live webcast of the NASDAQ Opening Bell will be available at:

http://www.nasdaq.com/reference/marketsite_about.stm

Photos

To obtain a hi-resolution photograph of the Market Open, please go to the following and click on the market open of your choice:

http://www.nasdaq.com/reference/marketsite_events.stm

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a specialty pharmaceutical company that is focused on developing innovative products to address growing market opportunities, including conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop, partner, and commercialize new products using proven therapeutics. BDSI’s pain franchise currently consists of two products utilizing the Company’s patented BEMA buccal soluble film technology: ONSOLIS (fentanyl buccal soluble film) which was approved by FDA on July 16, 2009 for the management of breakthrough pain in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain, and BEMA Buprenorphine, an analgesic in Phase 2 clinical development with at least one potential target indication for the treatment of moderate to severe pain. The company is working with its BEMA technology and its patented Bioral cochleate technology on products targeted at conditions common to oncology and surgical patients such as pain and infections. The company’s headquarters is located in Raleigh, North Carolina. For more information please visit www.biodeliverysciences.com.

BDSI^®, BEMA^® and Bioral^® are registered trademarks, and ONSOLIS^TM is a trademark of BioDelivery Sciences International, Inc.

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 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).