Edgar Filing: BIODELIVERY SCIENCES INTERNATIONAL INC

January 14, 2008

BIODELIVERY SCIENCES INTERNATIONAL, INC.

/s/ James A. McNulty

James A. McNulty

Secretary, Treasurer and Chief Financial Officer

Form 8-K

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) January 14, 2008 (January 10, 2008)

BioDelivery Sciences International, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-31361

35-2089858

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

2501 Aerial Center Parkway, Suite 205

Morrisville, North Carolina

27560

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (919) 653-5160

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:

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Items 7.01 and 8.01. Regulation

FD Disclosure and Other Information.

On January 10, 2008, BioDelivery Sciences International, Inc. (the “Company”) issued a press release relating to the U.S. Food and Drug Administration’s (“FDA”) acceptance for filing of the Company’s new drug application (“NDA”) for BEMA™ Fentanyl, which NDA was submitted to FDA by the Company on October 31, 2007. The press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

On January 14, 2008, the Company issued a press release relating to the expansion of the Company’s clinical development program for its lead product, BEMA^TM Fentanyl, to assess the efficacy and safety of the product for the treatment of breakthrough pain associated with other chronic pain conditions beyond cancer. The press release is attached to this Current Report on Form 8-K as Exhibit 99.2.

Item 9.01.

Financial Statements and Exhibits.

(d)

Exhibits


99.1		Press release, dated January 10, 2008, regarding the FDA’s acceptance for filing of the Company’s NDA for BEMA™ Fentanyl.

99.2		Press release, dated January 14, 2008, regarding the Company’s expansion of its clinical development program for BEMA™ Fentanyl.

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).

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.