SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or Section 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 6, 2014
BioDelivery Sciences International, Inc.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction
801 Corporate Center Drive, Suite #210
|(Address of principal executive offices)||(Zip Code)|
Registrants telephone number, including area code: 919-582-9050
(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))|
|Item 8.01.||Other Information.|
On May 6, 2014, BioDelivery Sciences International, Inc. (the Company) issued a press release announcing it has randomized more than half of the planned number of patients required for its ongoing initial Phase 3 study of Clonidine Topical Gel, the Companys proposed treatment for painful diabetic neuropathy (PDN). An interim analysis of the study, which will be based on the first 50% of patients entering the study, is now anticipated to occur in the third quarter of 2014. A copy of such press release is attached as Exhibit 99.1 hereto.
|Item 9.01.||Financial Statements and Exhibits.|
|99.1||Press release, dated May 6, 2014, announcing the Company has randomized more than half of the planned number of patients required for its ongoing initial Phase 3 study of Clonidine Topical Gel.|
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. The BioDelivery Sciences logo and BUNAVAIL are trademarks owned by BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is a trademark owned by Meda Pharma GmbH & Co. KG. PAINKYLTM is a trademark owned by TTY Biopharm. All other trademarks and tradenames are owned by their respective owners.
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 Companys 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 Companys management and are subject to significant risks and uncertainties, including those detailed in the Companys filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of the FDAs review of BUNAVAIL, the results of the Companys commercial efforts for BUNAVAIL, and the results of the Companys clinical trials for BEMA Buprenorphine and Clonidine Topical Gel described in the attached press release) 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 Companys 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.
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.
|May 6, 2014||BIODELIVERY SCIENCES INTERNATIONAL, INC.|
|Name:||Ernest R. De Paolantonio|
|Title:||Chief Financial Officer and Secretary|