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
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 (17CFR
240.14a-12)
|
|
¨
|
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 May 3, 2010 we issued a joint press
release with King Pharmaceuticals, Inc. announcing the Companies’ plans to
develop and submit a New Drug Application (NDA) for Acurox®
(oxycodone HC1) Tablets (without niacin). The Companies also
announced plans to develop and submit an NDA for two additional immediate
release opioid analgesic products; Vycavert®
(hydrocodone bitartrate/acetaminophen) Tablets and Acuracet®
(oxycodone HCl/acetaminophen) Tablets, intended to relieve pain and introduce
limits and impediments to nasal and intravenous abuse. A copy of our
press release is attached as Exhibit 99.1 hereto and is incorporated by
reference herein.
|
Item
9.01
|
Financial
Statements and Exhibits
|
|
Exhibit Number
|
Description
|
|
|
99.1
|
Press
Release dated May 3, 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 A.
Clemens
|
|
Peter
A. Clemens
|
|
|
Senior
Vice President & Chief Financial
Officer
|
|
Date: May
3, 2010
Exhibit
Index
|
Exhibit Number
|
Description
|
|
|
99.1
|
Press
Release dated May 3, 2010
|
  |
King
Pharmaceuticals Contact:
Jack
Howarth, VP Investor Relations
908-429-8350
Acura
Pharmaceuticals Contact:
Peter
Clemens, SVP & CFO
847-705-7709
|
KING
PHARMACEUTICALS AND ACURA PHARMACEUTICALS ANNOUNCE
PLANS
TO SUBMIT AN NDA FOR ACUROX® TABLETS
WITHOUT NIACIN
***
Submission Targeted for Early 2011 ***
BRISTOL, TENNESSEE and PALATINE,
ILLINOIS, May 3, 2010 — King Pharmaceuticals, Inc. (NYSE: KG) and Acura
Pharmaceuticals, Inc. (NASDAQ: ACUR) today announced that the Companies plan to
develop and submit a New Drug Application (NDA) for Acurox®
(oxycodone HC1) Tablets (without niacin) intended to relieve moderate to
severe pain and introduce limits and impediments to potential abuse via nasal
snorting of crushed tablets and intravenous injection of dissolved
tablets. At an April 22, 2010 joint Advisory Committee meeting, the
U.S. Food and Drug Administration (FDA) questioned the effectiveness of niacin
included in the current Acurox®
formulation but cited no concerns with the snorting and intravenous abuse
limiting features of the product. The Companies expect to submit an
NDA for Acurox® Tablets
(without niacin) in early 2011.
The
Companies also plan to develop and submit NDA’s for two additional immediate
release opioid analgesic products utilizing Acura’s proprietary Aversion®
Technology; Vycavert®
(hydrocodone bitartrate/acetaminophen) Tablets and Acuracet®
(oxycodone HCl/acetaminophen) Tablets. Like Acurox®, these
additional product candidates are patent protected compositions comprising a
mixture of active and inactive ingredients intended to relieve pain and
introduce limits and impediments to nasal and intravenous abuse.
About
Acurox® Tablets
(without niacin)
Acurox® (without
niacin) is substantially the same as the current Acurox®
formulation except niacin has been removed from the product. The
Companies have successfully scaled up and manufactured Acurox® Tablets
(without niacin) and completed a clinical study demonstrating that Acurox® (without
niacin) is bioequivalent to the FDA-approved oxycodone HCl Reference Listed Drug
and to the Acurox® Tablet
formulation with niacin. The Companies expect to conduct confirmatory
studies that, if successful, will be included in the NDA
submission. The Companies anticipate that the proposed labeling for
Acurox® (without
niacin) will allow greater dosing flexibility than was proposed for the
Acurox®
formulation with niacin since the ability to utilize the full dose range of
immediate release oxycodone was limited by niacin.
1
About
Acura Pharmaceuticals, Inc.
Acura
Pharmaceuticals, Inc., is a specialty pharmaceutical company engaged in
research, development and manufacture of product candidates intended to
introduce limits and impediments to abuse utilizing the Company’s proprietary
Aversion®
Technology, Impede™ Technology, and other novel technologies. Acura
entered into a License, Development and Commercialization Agreement with King
Pharmaceuticals®, Inc.,
in October 2007 pursuant to which Acura and King are now jointly developing
Acurox® Tablets
(without niacin) and two additional immediate release opioid analgesic product
candidates utilizing Aversion®
Technology.
About
King Pharmaceuticals, Inc.
King,
headquartered in Bristol, Tennessee, is a vertically integrated branded
pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize
on opportunities in the pharmaceutical industry through the development,
including through in-licensing arrangements and acquisitions, of novel branded
prescription pharmaceutical products and technologies that complement the
Company’s focus in specialty-driven markets, particularly neuroscience and
hospital. King’s wholly owned subsidiary, Alpharma Inc., is also a leader in the
development, registration, manufacture, and marketing of pharmaceutical products
for food-producing animals.
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 "estimate," "project," "anticipate,"
"expect," "intend," "believe," and similar expressions are intended to identify
forward-looking statements. Examples of forward-looking statements in this
press release include statements concerning the FDA views about Acurox®, the
expectation that the Companies will successfully complete additional studies and
submit a NDA by a certain date or at all and the expectation relating to the
product label for Acurox®. King
Pharmaceuticals, Inc. and Acura Pharmaceuticals, Inc. disclaim 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 each of the Companies’ Annual Reports on Form 10-K for the fiscal
year ended December 31, 2009, each of which is on file with the U.S. Securities
and Exchange Commission.
ADMINISTRATIVE
OFFICES
ACURA
PHARMACEUTICALS, INC.
616
N. NORTH COURT, PALATINE, ILLINOIS 60067
KING
PHARMACEUTICALS, INC.
501
FIFTH STREET, BRISTOL, TN 37620
ACUROX
and AVERSION are registered trademarks and IMPEDE is a trademark of Acura
Pharmaceuticals, Inc.
2