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)
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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
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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.
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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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|||
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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
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Press
Release dated February 14,
2011.
|
Acura
Pharmaceuticals Contact:
Peter
Clemens, SVP & Chief Financial Offficer
847-705-7709
ACUROX® TABLETS
NEW DRUG APPLICATION ACCEPTED
FOR
FILING WITH A PRIORITY REVIEW CLASSIFICATION
PALATINE, ILLINOIS,
February 14, 2011 –
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) today announced that it has
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. In addition to
filing acceptance and assignment of a Priority review classification, the FDA’s
filing communication letter to King also includes preliminary comments about
potential review issues relating to an intranasal abuse liability study included
in the NDA and requests additional information relating to this study and other
issues. The preliminary notice of potential review issues is not
indicative of deficiencies that may be identified during the FDA’s review of the
NDA. No assurance can be given that any issues raised as part of the
FDA’s review of the ACUROX® NDA
(including the potential review issues in the FDA’s filing communication letter)
will be addressed to the FDA’s satisfaction or that the ACUROX® NDA will
be approved by the FDA.
About
ACUROX®
Tablets
ACUROX® is a
patented, immediate release tablet containing oxycodone HCl as its sole active
analgesic ingredient. ACUROX® is
intended for oral administration with a targeted indication 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.
About
Priority Review Classifications
The FDA
may assign an NDA a Priority review classification if its assessment of
conditions and information available at the time the application is filed
indicates the drug product has the potential to provide, among other things,
significant improvements compared to marketed products. A Priority
review classification by the FDA determines an NDA’s review timeline under PDUFA
and is not intended to predict FDA approval of a drug or its market acceptance
or sales potential.
About
Acura Pharmaceuticals, Inc.
Acura
Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research,
development and manufacture of product candidates intended to provide abuse
deterrent features and benefits utilizing the Company’s proprietary
Aversion® and
Impede™
Technologies, and other novel technologies. Acura entered into a License,
Development and Commercialization Agreement with King (a wholly owned subsidiary
of King Pharmaceuticals, Inc.) in October 2007 pursuant to which Acura and King
would jointly develop ACUROX® Tablets
(with and without niacin) and three additional opioid analgesic product
candidates utilizing Aversion® Technology. On October 11, 2010, King entered
into an agreement and plan of merger with Pfizer Inc. and on January 31, 2011
Pfizer announced the closing of the tender offer and that the completion of its
acquisition of King through a short-form merger would occur on or about February
28, 2011. Upon completion of the merger, King will become a
wholly-owned subsidiary of Pfizer.
Forward-Looking
Statements
This
press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 (the "Act"). When
used in this press release, the words “intend,” “expect,” “believe” and similar
expressions are intended to identify forward-looking statements. Examples of
forward-looking statements in this press release include statements concerning,
among other items: our expectations regarding interaction with the FDA; the
provision of additional information to the FDA relating to the ACUROX® NDA;
the ability to address the potential review issues raised by the FDA in its
letter of acceptance to the satisfaction of the FDA; the adequacy of the
clinical studies included in the ACUROX® NDA; and
the abuse limiting capabilities of ACUROX® and
Aversion®
Technology. Acura Pharmaceuticals, Inc. disclaims any intent or
obligation to update these forward-looking statements, and claim the protection
of the Safe Harbor for forward-looking statements contained in the
Act. Such forward-looking statements involve known and unknown risks,
uncertainties and other factors which may cause actual results, performance or
achievements to be materially different from any future results, performance, or
achievements expressed or implied by such forward-looking statements. 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 Acura’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2009, and its Quarterly Reports on Form 10-Q for the quarter ended
September 30, 2010, each of which is on file with the U.S. Securities and
Exchange Commission.
ACUROX
and AVERSION are registered trademarks of Acura Pharmaceuticals,
Inc.