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EX-99.1 - ACURA PHARMACEUTICALS, INC | v206024_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.
|