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) April 27, 2007 (April 25, 2007)

 


BioDelivery Sciences International, Inc.

(Exact name of registrant as specified in its charter)

 


 

Delaware   0-28931   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 April 25, 2007, BioDelivery Sciences International, Inc. (the “Company”) issued a press release relating to Company’s announcement of top line efficacy results from the Company’s Phase III clinical trial regarding BEMATM Fentanyl. The press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

99.1   Press release, dated April 25, 2007, regarding BEMATM Fentanyl Phase III efficacy results.

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.

 

April 27, 2007

    BIODELIVERY SCIENCES INTERNATIONAL, INC.
   

By:

 

/s/ James A. McNulty

   

Name:

  James A. McNulty
   

Title:

  Secretary, Treasurer and Chief Financial Officer