Attached files
| file | filename |
|---|---|
| EX-99.1 - ACURA PHARMACEUTICALS, INC | v211201_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
February
14, 2011
Date of Report (Date of earliest event
reported)
___________________________________________________________
ACURA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in Charter)
___________________________________________________________
|
State
of New York
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1-10113
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11-0853640
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|
(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):
|
o
|
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR
240.13e-4(c))
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Item
8.01 Other Events
On February 14, 2011, we issued a press release, filed
herewith as Exhibit 99.1, announcing that we have been informed by King
Pharmaceuticals Research and Development Inc. (“King”) that King’s New Drug
Application (“NDA”) for Acurox® (oxycodone HCl) Tablets was accepted for filing
by the US Food and Drug Administration (“FDA”) with a Priority review
classification and a Prescription Drug User Fee Act (PDUFA) date of June 17,
2011. ACUROX® is an immediate release tablet containing oxycodone HCl
intended for the relief of moderate to severe pain. ACUROX® Tablets utilize
Acura’s patented Aversion® Technology which is designed to limit or impede
opioid abuse via intravenous injection of dissolved tablets and nasal snorting
of crushed tablets. ACUROX® Tablets do not contain niacin.
In
addition to accepting King’s submission for filing and assigning a Priority
review classification, the FDA’s filing communications letter for ACUROX® Tablets
provided preliminary notice of potential review issues relating to King’s
intranasal abuse liability study included in the NDA and requested additional
information relating to such study and other issues.
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 February 14,
2011.
|
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.
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ACURA
PHARMACEUTICALS, INC.
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|||
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By:
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/s/ Peter A. Clemens | ||
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Peter
A. Clemens
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|||
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Senior
Vice President & Chief Financial Officer
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|||
Date: February
14, 2011
EXHIBIT
INDEX
| Exhibit Number | Description |
|
99.1
|
Press
Release dated February 14,
2011.
|