UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or Section 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 16, 2015

BioDelivery Sciences International, Inc.

(Exact name of registrant as specified in its charter)

Registrant’s telephone number, including area code: 919-582-9050

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation to the registrant under any of the following provisions:

On July 16, 2015, BioDelivery Sciences International, Inc. (the “Company”) held its 2015 annual meeting of stockholders (the “Annual Meeting”). The number of shares of common stock entitled to vote at the Annual Meeting was 52,403,027. The number of shares of common stock present or represented by valid proxy at the Annual Meeting was 43,260,001. All matters submitted to a vote of the Company’s stockholders at the Annual Meeting were approved and the director nominees were elected.

The following is a tabulation of the voting on the proposals presented at the Annual Meeting:

Proposal 1: To elect Frank E. O’Donnell, Barry I. Feinberg and Samuel P. Sears, Jr. as Class I directors, each to serve for a three-year term that expires at the 2018 annual meeting of stockholders or until his successor is elected and qualified or until his earlier resignation or removal.

Proposal 2: To ratify the appointment by the Audit Committee of the Company’s Board of Directors of Cherry Bekaert LLP as the Company’s registered public accounting firm for the fiscal year ending December 31, 2015.

Proposal 3: To approve an amendment to the Company’s 2011 Equity Incentive Plan to, among other matters described in the Company’s proxy statement on Schedule 14A for its 2015 Annual Meeting, as filed with the Securities and Exchange Commission on June 5, 2015 (the “Proxy”), increase the number of shares of common stock authorized for issuance under the plan by 2,250,000 shares from 8,800,000 to 11,050,000 (the “Plan Amendment”). A summary of the Plan Amendment was included as part of Proposal No. 3 contained on pages 41-50 of the Proxy. The information regarding the Plan Amendment contained herein is qualified in its entirety by reference to the actual terms of the Plan Amendment, which is filed as Annex A to the Proxy and incorporated herein by reference.

Cautionary Note Regarding Forward-Looking Statements

This Current Report on Form 8-K of the Company 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, many of which are beyond the Company’s control. 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. 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.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.