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
January
2, 2009
Date of Report (Date of earliest event
reported)
ACURA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in Charter)
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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)
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(I.R.S.
Employer
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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):
¨ 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 January 2, 2009, we announced that
we submitted a New Drug Application (NDA) for Acurox®
(oxycodone HCl/niacin) Tablets to the U.S. Food and Drug Administration (FDA)
including a request for priority review. The FDA is expected to
determine whether to accept the NDA for filing and consider the priority review
request within 60 days. Acurox®, a
patented, orally administered, immediate release tablet containing oxycodone HCl
as its sole active analgesic ingredient, has a proposed indication for the
relief of moderate to severe pain. Acurox® utilizes
Acura’s patented Aversion®
Technology, which is designed to deter misuse and abuse by intentional
swallowing of excess quantities of tablets, intravenous injection of dissolved
tablets and nasal snorting of crushed tablets.
We have licensed the rights to the
Acurox® tablets in the United States, Canada and Mexico to King Pharmaceuticals
Research and Development, Inc. (“King”), a wholly-owned subsidiary of King
Pharmaceuticals, Inc., pursuant to a License, Development and Commercialization
Agreement dated as of October 30, 2007 between King and us, as
amended. A press release issued by us in connection with the NDA
filing is furnished as Exhibit 99.1.
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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Joint
Press Release of the Registrant and King Pharmaceuticals, Inc. dated
January 2, 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 Clemens
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Peter
A. Clemens
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Senior
Vice President & Chief Financial
Officer
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Date: January 2,
2009
EXHIBIT
INDEX
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Description
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99.1
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Joint
Press Release of the Registrant and King Pharmaceuticals, Inc. dated
January 2, 2009.
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King
Pharmaceuticals Contacts:
James
E. Green, Executive Vice President, Corporate Affairs
423-989-8125
David
E. Robinson, Senior Director, Corporate Affairs
423-989-7045
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Acura
Pharmaceuticals Contact:
Peter
A. Clemens, SVP Investor Relations & CFO
847-705-7709
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NEW
DRUG APPLICATION SUBMITTED FOR ACUROX®
TABLETS
—
Opioid Analgesic Product Designed to Deter Prescription Drug Abuse
—
PALATINE,
ILLINOIS and BRISTOL, TENNESSEE, January 2, 2009 – Acura Pharmaceuticals, Inc.
(NASDAQ: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) today announced that
Acura has submitted a New Drug Application (NDA) for Acurox® (oxycodone
HCl/niacin) Tablets to the U.S. Food and Drug Administration (FDA)
including a request for priority review. The FDA is expected to
determine whether to accept the NDA for filing and consider the priority review
request within 60 days. If approved, Acura and King believe
Acurox® will be
the first FDA approved immediate release opioid analgesic designed to deter
swallowing excess quantities of tablets and other common methods of misuse and
abuse. According to the National
Survey on Drug Use and Health published by the Substance Abuse and Mental Health
Services Administration in 2006, immediate-release opioids are abused 10 times
more frequently than extended-release opioids.1
About
Acurox® Tablets
and the NDA Submission
Acurox®, a patented,
orally administered, immediate release tablet containing oxycodone HCl as its
sole active analgesic ingredient, has a proposed indication for the relief of
moderate to severe pain. Acurox® utilizes
Acura’s patented Aversion®
Technology, which is designed to deter misuse and abuse by intentional
swallowing of excess quantities of tablets, intravenous injection of dissolved
tablets and nasal snorting of crushed tablets. The NDA submission for
Acurox®
Tablets
includes positive results from the following studies and a proposed product
label describing these studies:
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·
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a
pivotal Phase III clinical efficacy and safety study conducted pursuant to
an FDA agreed Special Protocol Assessment with statistically significant
(p≤0.0001) primary efficacy
endpoints;
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·
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three
clinical studies assessing the abuse-liability potential of Acurox®,
demonstrating with statistical significance that subjects with a history
of opioid abuse disliked Acurox®
compared to immediate release oxycodone HCl alone when snorting crushed
tablets or swallowing excess numbers of tablets;
and
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·
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two
laboratory studies assessing the difficulty of intravenously injecting the
oxycodone active opioid ingredient contained in Acurox®
Tablets.
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About
Aversion®
Technology
Aversion®
Technology is a patented composition of active and inactive ingredients intended
to relieve moderate to severe pain and deter common methods of prescription drug
abuse, including intravenous injection of dissolved tablets, nasal snorting of
crushed tablets, and intentional swallowing of excess numbers of
tablets.
About
Prescription Drug Abuse
The
misuse, abuse and diversion of opioid containing pain medications has become
widespread in the U.S. and poses a costly and significant public health
issue. In addition to the often harmful impact on abusers and their
families the estimated cost associated with prescription opioid abuse, including
health care, justice, and work-related costs, totaled $9.5 billion in 2005.2 The
pain relief medicines that Acura is developing with King are designed to address
this rapidly growing problem.
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, hospital and acute care. King is also a leader in the
development, registration, manufacturing and marketing of pharmaceutical
products for food producing animals.
About
Acura Pharmaceuticals, Inc.
Acura
Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research,
development and manufacture of innovative Aversion® (abuse deterrent) Technology
and related product candidates. Acura entered into a License,
Development and Commercialization Agreement (the “Agreement”) with King
Pharmaceuticals, Inc. in October 2007 pursuant to which the Companies are now
jointly developing Acurox® and
three additional Aversion®
Technology immediate release opioid product candidates. The Agreement
provides King with an option to license all opioid analgesic products utilizing
Aversion®
Technology for development and commercialization in the United States, Canada
and Mexico.
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. Acura Pharmaceuticals, Inc. and King
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. These risk factors include, but are
not limited to, the timing and ability to gain FDA filing acceptance for the
Acurox® Tablets
NDA, the timing and results of FDA’s review for the request for priority review
of the Acurox® Tablets
NDA, the expectation that Acurox® Tablets will be the first FDA approved
immediate release opioid analgesic indicated for relief of moderate to severe
pain designed to deter common methods of abuse, the plans and ability to
develop, obtain regulatory approvals, manufacture and commercialize Acurox® Tablets
and the other Aversion®
Technology opioid product candidates, the ability to avoid infringement of
patents, trademarks and other proprietary rights of third parties, the market
size, market potential, and competition for Acurox® and the
other Aversion®
Technology opioid product candidates, and the ability to gain FDA approval of
product labeling for the proposed indication or the abuse deterrent features and
benefits of Acurox®. You
are encouraged to review these and other risks and uncertainties detailed in
each company’s respective 2007 SEC Form 10-K and September 30, 2008 SEC Form
10-Q.
1National
Survey on Drug Use and Health Report, Issue 22, 2006
2Birnbaum
HG, White AG, Reynolds JL, et al. Estimated Costs of Prescription Opioid
Analgesic Abuse in the United States in 2001. Clin J Pain 2006;
22(8).
EXECUTIVE
OFFICES
KING
PHARMACEUTICALS, INC.
501
FIFTH STREET, BRISTOL, TENNESSEE 37620
ACURA
PHARMACEUTICALS, INC.
616
N. NORTH COURT, PALATINE, ILLINOIS 60067