Unassociated Document
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
June
23, 2009
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
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(Commission
File Number)
|
(I.R.S.
Employer
|
|
of
Incorporation)
|
|
Identification
Number)
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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)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17CFR240.14d-2(b))
o Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17CFR 240.13e-4(c))
Item
8.01 Other
Events.
On June
18, 2009 we (the “Company”) received from the U.S. Food and Drug
Administration (“FDA”) a review letter
related to our New Drug Application (“NDA”) for Acurox® (oxycodone
hydrochloride/niacin) Tablets. On February 22, 2009, Acurox® was
granted a priority review classification by the FDA with a Prescription Drug
User Fee Act (“PDUFA”) date of June 30, 2009. FDA stated in the
review letter that their comments are preliminary, subject to change, and do not
reflect a final decision on the information reviewed or a review of the entire
NDA.
Based on
this review letter, we do not believe Acurox® Tablets will receive NDA approval
on the PDUFA date. As previously disclosed in the Company's filings
with the Securities and Exchange Commission, no assurance can be given that FDA
approval of the NDA for Acurox® Tablets will be received.
The
Company is a party to an exclusive License Agreement with King Pharmaceuticals
Research and Development, Inc. ("King"), a subsidiary of King Pharmaceuticals,
Inc., for the development and commercialization of certain opioid analgesic
products utilizing our Aversion® Technology in the United States, Canada and
Mexico. The License Agreement provides King with an exclusive license for
Acurox® (oxycodone hydrochloride and niacin) Tablets.
On June
23, 2009 we issued a press release relating to the foregoing. A copy
of the press release is attached as Exhibit 99.1.
FORWARD-LOOKING
STATEMENTS
This
report contains forward-looking statements which reflect management’s current
views of future events and operations, including, but not limited to, statements
pertaining to the Company’s expectations regarding the FDA's review of the
Company's NDA for Acurox® (oxycodone hydrochloride and niacin) Tablets. These
forward-looking statements involve certain significant risks and uncertainties,
and actual results may differ materially from the forward-looking statements. A
factor which may cause results to differ is dependence on the unpredictability
of the duration and results of the FDA’s review of the Company's NDA for Acurox®
(oxycodone hydrochloride and niacin) Tablets. Other important factors
that may cause actual results to differ materially from the forward-looking
statements are discussed in the “Risk Factors” section and other sections of the
Company’s Form 10-K for the year ended December 31, 2008, and Form 10-Q for the
first quarter ended March 31, 2009, which are on file with the U.S. Securities
and Exchange Commission. The Company does not undertake to publicly
update or revise any of its forward-looking statements even if experience or
future changes show that the indicated results or events will not be
realized.
Item
9.01 Financial
Statements and Exhibits.
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Exhibit
Number
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Description |
| |
|
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99.1
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Press
Release dated June 23,
2009
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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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By:
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/s/ Peter
A. Clemens |
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Peter
A. Clemens |
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Senior
Vice President & Chief FinancialOfficer |
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Date: June
23, 2009
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Exhibit
Number
|
Description |
| |
|
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99.1
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Press
Release dated June 23,
2009
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