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
April
24, 2008
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):
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))
On
April
24, 2008, the Registrant issued a press release announcing the completion of
patient enrollment for a Phase III clinical trial evaluating
Acurox.
Item
9.01
|
Financial
Statements and Exhibits.
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release dated April 24, 2008 announcing the completion of patient
enrollment for a Phase III clinical trial evaluating Acurox.
|
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:
April 24, 2008
EXHIBIT
INDEX
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release dated April 24, 2008 announcing the completion of patient
enrollment for a Phase III clinical trial evaluating Acurox.
|
|
King
Pharmaceuticals Contacts:
James
E. Green, Executive Vice President, Corporate Affairs
423-989-8125
David
E. Robinson, Senior Director, Corporate Affairs
423-989-7045
|
|
|
|
Acura
Pharmaceuticals Contact:
Peter
A. Clemens, SVP Investor Relations & CFO
847-705-7709
|
FOR
IMMEDIATE RELEASE
KING
PHARMACEUTICALS AND ACURA PHARMACEUTICALS
ANNOUNCE
COMPLETION OF PATIENT ENROLLMENT FOR
PIVOTAL
PHASE III CLINICAL TRIAL EVALUATING ACUROX™
Top-line
Clinical Trial Results Expected by July 2008
NDA
Submission Expected before end of 2008
BRISTOL,
TENNESSEE and PALATINE, ILLINOIS, April 24, 2008 - King Pharmaceuticals, Inc.
(NYSE: KG) and Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) announced today the
completion of patient enrollment for the pivotal Phase III clinical trial
evaluating ACUROX™ Tablets for relief of moderate to severe pain. The companies
expect to report top-line results from this pivotal trial by July 2008 and
submit a New Drug Application (NDA) for ACUROX™ Tablets to the U.S. Food and
Drug Administration (FDA) before the end of 2008.
ACUROX™,
an immediate-release tablet, is a proprietary composition of oxycodone HCl,
niacin, and functional inactive ingredients intended to relieve moderate to
severe pain and resist or deter common methods of prescription drug abuse,
including intravenous injection of dissolved tablets, nasal snorting of crushed
tablets and intentional swallowing of excessive numbers of tablets.
Dr.
Eric
Carter, Chief Science Officer of King, commented, “This development milestone is
an important measure of our continued success in advancing exciting projects
to
further expand our pain management franchise. We expect that ACUROX™ Tablets
will be the first approved immediate-release opioid analgesic designed to resist
or deter common methods of prescription drug abuse.”
Dr.
Carter emphasized, “We are committed to developing immediate-release and
extended-release opioid analgesics that are proven safe and effective and
incorporate appropriate means to resist or deter abuse and misuse.”
King
and
Acura are working together to develop a wide range of immediate-release opioid
analgesics, including ACUROX™ Tablets, designed to resist or deter common
methods of prescription drug abuse. This will complement King’s ongoing
development of extended-release opioid analgesics designed to resist or deter
common methods of abuse.
The
under-treatment of pain is a major public health issue complicated by abuse
of
prescription opioids. More than 75 million Americans suffer from pain, which
is
more than the number of people with diabetes, heart disease and cancer combined.
While there are a number of prescription pain medications available, the
increasing misuse, abuse and diversion of prescription pain medications,
especially among young people, is having an impact on physicians’ ability and/or
willingness to treat pain and is impeding patient access to these medicines
and
appropriate care. Additionally, the increasing misuse, abuse and diversion
of
opioid pain medications has become wide spread and poses a costly and
significant public health issue in and of itself. The medicines King is
developing with Acura and other partners to treat pain are designed to address
this problem.
About
Immediate-Release and Extended-Release Opioid Analgesics
Immediate-release
opioid analgesics are typically administered every 6 hours for up to 30 days
for
relief of moderate to severe pain whereas extended-release opioid analgesics
are
usually administered every 12 to 24 hours for durations ranging from a few
weeks
to several months or longer for relief of chronic moderate to severe pain.
According to IMS Health, in 2007 there were approximately 221 million dispensed
prescriptions for immediate-release opioid analgesics and approximately 14
million dispensed prescriptions for extended-release opioid analgesics in the
United States.
About
ACUROX™ Tablets
ACUROX™
Tablets, an investigational drug, is an orally administered immediate-release
tablet containing oxycodone HCl as an active analgesic ingredient, niacin as
an
active ingredient in subtherapeutic amounts, and a proprietary composition
of
functional inactive ingredients. ACUROX™ Tablets are intended to relieve
moderate to severe pain while resisting or deterring common methods of
prescription drug abuse, including intravenous injection of dissolved tablets,
nasal snorting of crushed tablets and intentional swallowing of excessive
numbers of tablets. ACUROX™ is a proposed brand name subject to FDA
approval.
In
2007,
Acura reached agreement with the FDA on a Special Protocol Assessment for the
pivotal Phase III clinical trial evaluating ACUROX™ Tablets. This clinical trial
is a randomized, double-blind, placebo-controlled, multi-center, repeat-dose
study evaluating the safety and efficacy of ACUROX™ Tablets for the relief of
moderate to severe postoperative pain. The 3-arm clinical trial compares two
dose levels of ACUROX™ Tablets to placebo, enrolling approximately 135 patients
per arm (405 patients in total). Study medication is administered to patients
every 6 hours for 48 hours following the onset of moderate to severe pain
following bunionectomy surgery. Patient enrollment in this Phase III clinical
trial is now complete.
About
King Pharmaceuticals
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 in attractive markets and the strategic
acquisition of branded products that can benefit from focused promotion and
marketing and life-cycle management.
About
Acura Pharmaceuticals
Acura
Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research,
development and manufacture of innovative Aversion®
(abuse
deterrent) Technology and related product candidates.
Forward-looking
Statements
This
release contains forward-looking statements which reflect managements’ current
views of future events and operations, including, but not limited to, statements
pertaining to the expected timetable for the release of top-line data from
the
pivotal Phase III clinical trial evaluating ACUROX™
Tablets
and submission of the NDA for ACUROX™
Tablets
with the FDA; the expectation that ACUROX™ Tablets will be the first approved
immediate-release opioid treatment for relief of moderate to severe pain that
is
uniquely designed to deter common methods of abuse; and plans to develop other
immediate-release and extended-release opioid pain medicines. These
forward-looking statements involve certain significant risks and uncertainties,
and actual results may differ materially from the forward-looking statements.
Some important factors which may cause actual results to differ materially
from
the forward-looking statements include dependence on the successful development
of ACUROX™
and
other
immediate-release and extended-release opioid pain medicines; dependence on
King’s and Acura’s ability to release clinical data as planned; dependence on
the timely submission of an NDA for ACUROX™ with the FDA; dependence
on the companies’ ability to continue to advance the development of its pipeline
products as planned; dependence on the high cost and uncertainty of research,
clinical trials, and other development activities involving pharmaceutical
products in which the companies’ have an interest; dependence on the
unpredictability of the duration and results of FDA review of Investigational
New Drug applications (IND), NDAs and/or the review of other regulatory agencies
worldwide that relate to products in development; dependence on the availability
and cost of raw materials; dependence on no material interruptions in supply
by
contract manufacturers of products in development; dependence on the affect
of
the potential development and approval of other new competitive products;
dependence on unexpected adverse side-effects or inadequate therapeutic efficacy
of the companies’ drug candidates that could slow or prevent product approval or
market acceptance (including the risk that current and past results of clinical
trials are not necessarily indicative of future results of clinical
trials).
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 each of King’s and Acura’s respective Form 10-K for the year ended
December 31, 2007, which are on file with the U.S. Securities and Exchange
Commission. The companies do not undertake to publicly update or revise any
of
their forward-looking statements even if experience or future changes show
that
the indicated results or events will not be realized.
#
#
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EXECUTIVE
OFFICES
KING
PHARMACEUTICALS, INC.
501
FIFTH STREET, BRISTOL, TENNESSEE 37620
ACURA
PHARMACEUTICALS, INC.
616
N. NORTH COURT, PALATINE, ILLINOIS 60067