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EX-99.1 - ACURA PHARMACEUTICALS, INCv206024_ex99-1.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549
____________

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act Of 1934

December 20 , 2010
Date of Report (Date of earliest event reported)
___________________________________________________________

ACURA PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
___________________________________________________________

State of New York
1-10113
11-0853640
(State of Other Jurisdiction
(Commission File Number)
(I.R.S. Employer
of Incorporation)
 
Identification Number)

616 N. North Court, Suite 120
 Palatine, Illinois 60067
(Address of principal executive offices) (Zip Code)

(847) 705-7709
(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨           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 (17CFR 240.13e-4(c))

 
 

 

Item 8.01              Other Events

On December 20, 2010, we announced that King Pharmaceuticals, Inc (together with its affiliates, “King”) submitted a New Drug Application (NDA) for Acurox® (oxycodone HCl) Tablets  to the U.S. Food and Drug Administration (FDA) including a request for priority review classification.  Acurox® utilizes Acura’s patented Aversion® Technology, which is designed to deter opioid abuse by intravenous injection of dissolved tablets and nasal snorting of crushed tablets and does not contain niacin.  A press release issued by King and us in connection with the NDA filing is filed as Exhibit 99.1.

We have licensed the rights to the Acurox® tablets in the United States, Canada and Mexico to King pursuant to a License, Development and Commercialization Agreement dated as of October 30, 2007 between King and us, as amended.

Item 9.01             Financial Statements and Exhibits

Exhibit Number
 
Description
     
99.1
 
Press Release dated December 20, 2010.

 
 

 

SIGNATURES

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

ACURA PHARMACEUTICALS, INC.
   
By:
/s/ Peter Clemens
 
Peter A. Clemens
 
Senior Vice President & Chief Financial Officer

Date:      December 20, 2010

 
 

 
 
EXHIBIT INDEX
 
Exhibit Number
 
Description
     
99.1
 
Press Release dated December 20, 2010.