Item 8.01. Other Information.

On November 19, 2008, BioDelivery Sciences International, Inc. (the "Company") issued a press release announcing that it continues to anticipate a resubmission containing the Risk Evaluation and Mitigation Strategy for its lead product ONSOLIS™ to the Food and Drug Administration ("FDA") in December following a November 17, 2008 meeting with the FDA. A copy of the press release is attached to this Current Report as Exhibit 99.1.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

99.1 Press release, dated November 19, 2008, regarding the Company's November 17, 2008 meeting with the FDA.

This Current Report on Form 8-K and the exhibits hereto may contain, among other things, certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, 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. 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).

---