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
June
17,
2008
Date
of
Report (Date of earliest event reported)
ACURA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in Charter)
|
1-10113
|
11-0853640
|
|||
|
of
Incorporation)
|
(Commission
File Number)
|
(I.R.S.
Employer
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
June
17, 2008 we announced positive
top-line results from a pivotal Phase III study, AP-ADF-105 (“Study 105”). Both
strengths of Acurox™ Tablets met the primary pain relief endpoint compared to
placebo (p=.0001, and p<.0001). The most prevalent reported adverse events in
patients receiving Acurox™ Tablets were nausea, vomiting, dizziness, pruritis
and flushing. Study 105 was conducted under the U.S. Food and Drug
Administration (“FDA”) Special Protocol Assessment (“SPA”) provision. We have
licensed the rights to Acurox™ Tablets to King
Pharmaceuticals Research and Development, Inc. (“King”), a wholly-owned
subsidiary of King Pharmaceuticals, Inc., pursuant to a License, Development
and
Commercialization Agreement between King and us, dated as of October 30, 2007.
We
expect
to submit a New Drug Application (“NDA”) for Acurox™ Tablets to the FDA by the
end of this year with a targeted indication for the relief of moderate to severe
pain where the use of an immediate release, orally administered, opioid
analgesic tablet is appropriate.
Study
105
was a pivotal Phase III, randomized, double-blind, placebo-controlled clinical
trial evaluating the efficacy and safety of Acurox™ Tablets for relief of
moderate to severe pain following bunionectomy surgery. A total of 405 patients
were randomized to one of three treatment arms of approximately 135 patients
per
arm. One treatment arm received a dose of two Acurox™ (oxycodone HCl/niacin)
Tablets 5/30mg, a second treatment arm received a dose of two Acurox™ Tablets
7.5/30mg, and the third treatment arm received a dose of two placebo tablets.
Study drugs were administered every 6 hours. The primary endpoint was the sum
of
the difference in pain intensity, measured on a 100mm visual analog scale (VAS),
compared to baseline over a 48 hour period (“SPID48”).
Prior
to initiating Study 105, the study design, endpoints and statistical analysis
plan were submitted to and agreed by the FDA under a Special Protocol Assessment
and the study was conducted accordingly. Both Acurox™ Tablet strengths met the
primary endpoint: p=.0001 for Acurox™ Tablets 5mg/30mg and p<.0001 for
Acurox™ Tablets 7.5mg/30mg. The most prevalent reported adverse events in
patients receiving Acurox™ Tablets were nausea, vomiting, dizziness, pruritis
and flushing. Most adverse events were reported as mild or moderate and there
were no serious adverse events. Six patients (2.2%) receiving Acurox™ Tablets
withdrew from the study due to treatment-emergent adverse events compared with
no withdrawals for the placebo group.
A
copy of
the press release issued by us is being furnished as Exhibit 99.1.
Item
9.01 Financial
Statements and Exhibits
|
Exhibit Number
|
Description
|
|
|
99.1
|
Joint
Press Release of the Registrant and King Pharmaceuticals, Inc. dated
June
17, 2008.
|
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: June
17,
2008
EXHIBIT
INDEX
|
Exhibit Number
|
Description
|
|
|
99.1
|
Joint
Press Release of the Registrant and King Pharmaceuticals, Inc. dated
June
17, 2008.
|
 |
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
|
ACUROX™
TABLETS MEET PRIMARY ENDPOINT IN
PIVOTAL
PHASE III STUDY
Opioid
With a Unique Composition of Ingredients Intended
to
Deter Common Methods of Prescription Drug Abuse
PALATINE,
ILLINOIS and BRISTOL, TENNESEE- June 17, 2008 - Acura
Pharmaceuticals, Inc. (NASDAQ: ACUR) and King Pharmaceuticals, Inc. (NYSE:
KG)
today announced positive top-line results from Acura’s pivotal Phase III study,
AP-ADF-105 (“Study 105”). Both strengths of Acurox™ Tablets met the primary pain
relief endpoint compared to placebo (p=.0001, and p<.0001). The most
prevalent reported adverse events in patients receiving Acurox™ Tablets were
nausea, vomiting, dizziness, pruritis and flushing. Study 105 was conducted
under the U.S. Food and Drug Administration (“FDA”) Special Protocol Assessment
(“SPA”) provision. Acura and King expect to submit a New Drug Application
(“NDA”) for Acurox™ Tablets to the FDA by the end of this year with a targeted
indication for the relief of moderate to severe pain where the use of an
immediate release, orally administered, opioid analgesic tablet is
appropriate.
Acurox™
Tablets contain a unique composition of the opioid oxycodone HCl, niacin, and
several functional inactive ingredients and are intended to relieve 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 now jointly developing three immediate-release
opioid analgesics, including Acurox™ Tablets, using Acura's patented Aversion®
Technology.
Dr.
Ron
Spivey, Acura's Chief Scientific Officer, stated, "The successful achievement
of
the primary end point in Study 105 adds another important milestone to a growing
array of laboratory and clinical studies designed and conducted by Acura in
the
development of products using our Aversion® Technology. After nearly five years
of work, we look forward to submitting an Acurox™ NDA to the FDA by the end of
this year and have several additional NDA submissions planned over the next
few
years."
“These
solid Phase III results for Acurox™ represent continued progress toward our goal
to deliver medicines to physicians and patients that effectively manage pain,
while addressing the rise in prescription drug abuse,” stated Dr. Eric Carter,
Chief Science Officer of King. “At King Pharmaceuticals, we are dedicated to
developing innovative, clinically-differentiated pain medicines and Acurox™ has
the potential to be the first immediate release opioid on the U.S. market that
is designed to reduce the risk of misuse and abuse.”
1
About
Study 105
Study
105
was a pivotal Phase III, randomized, double-blind, placebo-controlled clinical
trial evaluating the efficacy and safety of Acurox™ Tablets for relief of
moderate to severe pain following bunionectomy surgery. A total of 405 patients
were randomized to one of three treatment arms of approximately 135 patients
per
arm. One treatment arm received a dose of two Acurox™ (oxycodone HCl/niacin)
Tablets 5/30mg, a second treatment arm received a dose of two Acurox™ Tablets
7.5/30mg, and the third treatment arm received a dose of two placebo tablets.
Study drugs were administered every 6 hours. The primary endpoint was the sum
of
the difference in pain intensity, measured on a 100mm visual analog scale (VAS),
compared to baseline over a 48 hour period (“SPID48”).
Prior
to initiating Study 105, the study design, endpoints and statistical analysis
plan were submitted to and agreed by the FDA under a Special Protocol Assessment
and the study was conducted accordingly. Both Acurox™ Tablet strengths met the
primary endpoint: p=.0001 for Acurox™ Tablets 5mg/30mg and p<.0001 for
Acurox™ Tablets 7.5mg/30mg. The most prevalent reported adverse events in
patients receiving Acurox™ Tablets were nausea, vomiting, dizziness, pruritis
and flushing. Most adverse events were reported as mild or moderate and there
were no serious adverse events. Six patients (2.2%) receiving Acurox™ Tablets
withdrew from the study due to treatment-emergent adverse events compared with
no withdrawals for the placebo group.
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.
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. In 2005, the total cost associated with opioid abuse, including health
care, justice, and work-related costs, totaled $9.5 billion2.
The
medicines that King is developing with Acura and other partners to treat pain
are designed to address this problem.
About
Aversion®
Technology
Opioid
pain medicines developed with the 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 excessive numbers of tablets. Tablets or capsules incorporating the Aversion®
Technology, when dissolved in water or other common solvents in a volume
suitable for injection, form a gelatinous mass that increases the difficulty
of
chemically extracting oxycodone HCl and creates a physical impediment to draw
the dissolved drug into a syringe. Pulverized and snorted tablets and capsules
use the same technology to limit the availability of drug through the nasal
mucosa and cause minor but unpleasant irritation to the nasal tissue.
In
addition, consumption of quantities of drug in excess of the intended amount
generates undesirable, yet reversible, effects causing general feelings of
discomfort.
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 in attractive markets and the strategic
acquisition of branded products that can benefit from focused promotion and
marketing and life-cycle management.
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
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.
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 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
designed to deter common methods of abuse; and plans to develop other opioid
pain medicines intended to deter abuse. 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 and laboratory 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 and Form 10-Q
for the quarter ended March 31, 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.
###
EXECUTIVE
OFFICES
KING
PHARMACEUTICALS, INC.
501
FIFTH STREET, BRISTOL, TENNESSEE 37620
ACURA
PHARMACEUTICALS, INC.
616
N. NORTH COURT, PALATINE, ILLINOIS 60067
3