On October 15, 2012, BioDelivery Sciences International, Inc. (the "Company") issued a press release announcing the commercial launch of the Company's product, BREAKYL (fentanyl buccal film) in the European Union, which triggered a final milestone payment of $2.5 million from Meda AB, the Company's commercial partner for BREAKYL in the European Union. The Company will also receive royalty on net sales of BREAKYL in the European Union. A copy of such press release is attached as Exhibit 99.1 hereto.

(d) Exhibits

99.1    Press release, dated October 15, 2012, announcing the commercial launch of
        the Company's product, BREAKYL (fentanyl buccal film) in the European
        Union.

BDSIŽ and BEMAŽ are registered trademarks of BioDelivery Sciences International, Inc.

Cautionary Note Regarding Forward-Looking Statements

This Current Report on Form 8-K, the press release included herein, and any 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," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" 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, with respect to sales of BREAKYL in Europe and resulting royalty payments to the Company) 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.