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
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1-10113
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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 (17 CFR
240.14a-12)
o Pre-commencement
communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d- 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
October
13, 2008
we
announced top-line results from Study AP-ADF-111 (Study 111) entitled "A Phase
II, Single-Center, Randomized, Double-Blind, Assessment of the Abuse Liability
of Acurox™ (oxycodone HCl and niacin) Tablets in Subjects with a History of
Opioid Abuse." Study 111 results demonstrate that Acurox™ Tablets are disliked
compared to oxycodone HCl tablets alone when excess doses are swallowed. These
results are statistically significant based on the dislike/like scores (p =
.033), the primary measure of abuse deterrence potential for the
study.
We
are
parties to a License, Development and Commercialization Agreement with King
Pharmaceuticals Research and Development, Inc. (“King”), a wholly-owned
subsidiary of King Pharmaceuticals, Inc. dated as of October 30, 2007, as
amended, pursuant to which, among other things, we have licensed Acurox™ Tablets
to King in the United States, Canada and Mexico.
A
copy of
the press release issued by us jointly with King Pharmaceuticals, Inc. with
respect to the above is being furnished as Exhibit 99.1.
Item
9.01 Financial
Statements and Exhibits
|
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
October 13, 2008.
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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.
|
ACURA
PHARMACEUTICALS, INC.
|
|
|
By:
|
/s/
Peter Clemens
|
|
Peter
A. Clemens
|
|
|
Senior
Vice President & Chief Financial
Officer
|
|
Date: October
13, 2008
EXHIBIT
INDEX
|
Description
|
||
|
Joint
Press Release of the Registrant and King Pharmaceuticals, Inc. dated
October 13, 2008.
|
 |
King
Pharmaceuticals Contacts:
James
E. Green, EVP, Corporate Affairs
423-989-8125
David
E. Robinson, Sr. Director, Corporate Affairs
423-989-7045
Acura
Pharmaceuticals Contact:
Peter
A. Clemens, SVP Investor Relations & CFO
847-705-7709
|
ACURA
PHARMACEUTICALS AND KING PHARMACEUTICALS
ANNOUNCE
POSITIVE TOP LINE RESULTS OF KEY CLINICAL STUDY
ASSESSING
ABUSE LIABILITY
Acurox™
Tablets Significantly Disliked
When
Excess Doses Are Swallowed
PALATINE,
ILLINOIS and BRISTOL, TENNESSEE– October 13, 2008 – Acura
Pharmaceuticals, Inc. (NASDAQ: ACUR) and King Pharmaceuticals, Inc. (NYSE:
KG)
today announced top-line results from Study AP-ADF-111 (Study 111) entitled
"A
Phase II, Single-Center, Randomized, Double-Blind, Assessment of the Abuse
Liability of Acurox™ (oxycodone HCl and niacin) Tablets in Subjects with a
History of Opioid Abuse." Study 111 results demonstrate that Acurox™ Tablets are
disliked compared to oxycodone HCl tablets alone when excess doses are
swallowed. These results are statistically significant based on the dislike/like
scores (p = .033), the primary measure of abuse deterrence potential for the
study.
Acurox™
Tablets contain a unique composition of oxycodone HCl, niacin, and essential
functional inactive ingredients, and are intended to relieve moderate to severe
pain while deterring common methods of prescription drug abuse. King and Acura
entered into a License, Development and Commercialization Agreement in October
2007. Based on this Agreement, the companies are jointly developing three
immediate-release opioid analgesics using Acura's patented Aversion® Technology
and plan to submit an Acurox™ Tablet New Drug Application (NDA) to the FDA later
this year.
About
Study 111
Study
111
was a phase II, single-center, randomized, double-blind, assessment of the
abuse
liability potential of Acurox™ (oxycodone HCl/niacin) Tablets in 30 subjects
with a history of opioid abuse. Fasted subjects received a single dose of study
drugs every 48 hours for 9 days and were enrolled in two dosing sequences.
The
first dosing sequence (Sequence 1) included randomized doses of (i) niacin
240mg
alone; (ii) a combination of oxycodone HCl 40mg with niacin 240mg (4 times
the
expected recommended dose of Acurox™ Tablets 5/30mg); and (iii) placebo tablets.
The objective of Sequence 1 was to assess the effects of oxycodone HCl on the
effects of niacin. The second dosing sequence (Sequence 2) included randomized
doses of (i) a combination of oxycodone HCl 40mg with niacin 240mg (4 times
the
expected recommended dose of Acurox™ Tablets 5/30mg) and (ii) oxycodone HCl 40mg
alone. Sequence 2 was designed to assess the abuse liability and abuse
deterrence potential of Acurox™ Tablets versus oxycodone HCl alone. On each
dosing day, vital sign measures and subjective and behavioral effects were
assessed before dosing (baseline) and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 12
hours after dosing. Vital signs included measurement of pupil size, blood
pressure, heart rate, oral temperature and respiratory rate. For both Sequence
1
and Sequence 2, subjective changes were measured with a two item Drug Rating
Questionnaire-Subject (DRQS) and a 40 item short form of the Addiction Research
Center Inventory (ARCI). The ARCI was comprised of three scale scores including
the Morphine Benzedrine Group scale (MBG) measuring euphoria, the LSD/dysphoria
scale measuring somatic/bodily discomfort and dysphoria and the Pentobarbital
Chlorpromazine Alcohol Group scale (PCAG) measuring apathetic sedation. For
Sequence 2 only, in addition to the DRQS and ARCI, subjects also completed
a
Street Value Assessment Questionnaire and a Treatment Enjoyment Assessment
Questionnaire.
Sequence
1 results demonstrated that response to niacin 240 mg alone compared to placebo
causes significant dislike scores (p = .03), and significant LSD/dysphoria
scores (p < .001) with these negative niacin induced effects manifesting
rapidly, reaching peak at 0.5-1.5 hours and thereafter diminishing. At 0.5
hours
after drug administration, oxycodone HCl 40 mg has limited effect on
niacin-induced disliking and dysphoric effects. At the one hour observation
and
afterward, oxycodone may attenuate niacin-induced disliking and dysphoric
effects.
Sequence
2 demonstrated
that the combination of oxycodone HCl 40mg and niacin 240mg (4 times the
expected recommended dose of Acurox™ Tablets 5/30mg) had the potential to be
aversive when compared to oxycodone HCl 40mg alone as shown by statistically
significant and clinically meaningful results in the dislike/like scores (p
=
.033), the Treatment Enjoyment Assessment scores (p = .005) and the
LSD/dysphoria scores (p<.001). The dislike/like score at 0.5 hours was
designated the primary measure of abuse liability and abuse deterrence potential
for Acurox™ Tablets 5/30mg and the Treatment Enjoyment Assessment scores and
LSD/dysphoria scores at 0.5 hours were additional measures of the abuse
deterrence potential of Acurox™ Tablets. Subjective measures not achieving
statistical significance included the MBG scores measuring euphoria, the PCAG
score measuring apathetic sedation and the Street Value Assessment Questionnaire
score, in which subjects indicated they would pay more for oxycodone HCl alone
compared to Acurox™ Tablets (p=.097).
In
this
study of 30 subjects with a history of opioid abuse there were no serious
adverse events reported. Alterations by niacin compared to placebo on vital
signs were minimal and not clinically meaningful. The differences in vital
signs
between oxycodone HCl/niacin and niacin alone at 4 times the expected
recommended dose of Acurox™ Tablets were minimal and not clinically
meaningful.
About
Prescription Drug 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 using opioid analgesics and is impeding patient access
to these medicines and appropriate care. According to the National Institute
on
Drug Abuse, nearly 10 percent of high school seniors have abused
Vicodin®1,
a
commonly used short acting opioid pain medicine. The increasing misuse, abuse
and diversion of opioid pain medications have become widespread and pose a
costly and significant public health issue in and of itself. In 2005, the
estimated total cost associated with opioid abuse, including health care,
justice, and work-related costs, totaled $9.5 billion2.
The
pain relief medicines that Acura is developing with King are designed to address
this problem.
About
Aversion®
Technology
Opioid
pain medicines developed with Aversion®
Technology are intended to relieve moderate to severe pain while deterring
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. Tablets or capsules incorporating Aversion®
Technology, when dissolved in water or other common solvents in a volume
suitable for intravenous injection, form a gelatinous mass that increases the
difficulty of chemically extracting oxycodone HCl and creates a physical
impediment to drawing the dissolved drug into a syringe. Products developed
using Aversion® Technology are expected to cause irritation to the nasal
passages when attempts are made to snort crushed tablets. In
addition, products utilizing Aversion® Technology are designed to cause
disliking, bodily discomfort and dysphoric or unpleasant effects when excess
quantities of tablets are swallowed.
1
Johnston, LD, O’Malley, PM, Bachman, JG, Schulenberg, JE. Secondary School
Students. Monitoring the Future: National Survey Results on Drug Use, 1975-2006.
Bethesda, MD: National Institute on Drug Abuse; 2007. NIH Publication
07-6205.
2 Birnbaum
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).
2
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 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, 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.
About
Forward-looking Statements
This
release contains forward-looking statements reflecting current views of future
events including, but not limited to, statements pertaining to the expected
timing for submission of the NDA for Acurox™
Tablets
with the FDA; and statements and expectations relating to the potential of
Acurox™
Tablets
and other Aversion®
Technology product candidates. 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
opioid pain medicines; dependence on King’s and Acura’s ability to complete
clinical and laboratory studies as planned; dependence on the timely submission
of an NDA for Acurox™ with the FDA; dependence on whether information about the
abuse deterrent characteristics of Aversion®
Technology
product candidates are included in the FDA approved label for such products;
dependence on Acura’s and King’s ability to differentiate Aversion®
Technology product candidates from other opioid products based on information
included in the FDA approved label for such products ; dependence on the
companies’ ability to continue to advance the development of its pipeline
products as planned; dependence on the 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 and Form 10-Q for the quarter ended June 30, 2008, 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
4