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
19,
2007
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
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|
(State
of Other Jurisdiction
|
(Commission
File Number)
|
(I.R.S.
Employer
|
|
of
Incorporation)
|
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):
|
o
|
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
|
o
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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))
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Item
8.01 Other
Events
On
June
19, 2007 the Registrant issued a press release announcing it had reached
agreement with the U.S. Food & Drug Administration for a special protocol
assessment of a Phase III clinical trial entitled “Study AP-ADF-105: A Phase 3,
Randomized, Double-Blinded, Placebo-Controlled, Multicenter, Repeat-Dose Study
of the Safety and Efficacy of OxyADF (oxycodone HCl and niacin) Tablets for
the
Treatment of Acute, Moderate to Severe Postoperative Pain Following Bunionectomy
Surgery in Adult Patients”. The press release is attached as Exhibit
99.1.
Item
9.01 Financial
Statements and Exhibits
|
Exhibit
Number
|
Description
|
|
99.1
|
Press
Release announcing agreement with U.S. Food & Drug Administration with
respect to a Special Protocol
Assessment
|
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.
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|
|
By:
/s/ Peter A.
Clemens
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|
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Peter A. Clemens
|
|
|
Senior Vice President & Chief Financial
Officer
|
Date: June
19,
2007
Exhibit
Index
|
Exhibit
Number
|
Description
|
|
99.1
|
Press
Release announcing agreement with U.S. Food & Drug Administration with
respect to a Special Protocol
Assessment
|
CONTACT:
Acura
Pharmaceuticals, Inc.,
Investor
Relations, Peter A. Clemens, SVP & CFO 847-705-7709
FOR
IMMEDIATE RELEASE
Acura
Pharmaceuticals, Inc. and FDA Reach Agreement on Special
Protocol
Assessment
for Pivotal Phase 3 Study for OxyADF Tablets
Palatine,
IL,
June
19, 2007:
Acura
Pharmaceuticals, Inc. (OTC.BB-ACUR) (the
Company)
today
announced it has reached agreement with the US Food and Drug Administration
(FDA)
on a
Special Protocol Assessment (SPA)
for a
pivotal Phase 3 trial of OxyADF Tablets. A SPA is a process in which the FDA
provides evaluation and guidance on protocols for Phase 3 clinical trials.
The
FDA's agreement to the SPA confirms that the design, primary endpoint, and
planned statistical analyses of the study adequately addresses the requirements
supporting a New Drug Application (NDA) submission for OxyADF Tablets. The
FDA
previously communicated to the Company that only one successful Phase 3 pivotal
study will be required prior to NDA submission. While there can be no assurance
as to the safety or efficacy results of the Phase 3 trial for OxyADF Tablets,
if
the Company follows the agreed-upon protocol, then much of the uncertainty
associated with the design of this study should be removed. A SPA is binding
upon the FDA unless the trial protocol is changed by the Company or a
substantial scientific issue essential to determining safety or efficacy is
identified after the testing begins.
OxyADF
Tablet Pivotal Phase 3 Study Design
The
OxyADF Tablet pivotal trial, AP-ADF-105 (Study
105),
is
titled “A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter,
Repeat-dose Study of the Safety and Efficacy of OxyADF (oxycodone HCl and
niacin) Tablets for the Treatment of Acute, Moderate to Severe Postoperative
Pain Following Bunionectomy Surgery in Adult Patients.” Study 105 is a 3-arm
study comparing two dose levels of OxyADF Tablets to placebo. Study medication
in all three study arms will be administered every six hours for 48 hours
following the onset of moderate to severe pain following surgery. Study 105
is
anticipated to enroll 135 patients per arm (approximately 405 patients in
total). In May 2007, in anticipation of receiving FDA agreement to the SPA,
the
Company executed a Clinical Trial Development Agreement with a leading Contract
Research Organization and commenced preliminary start-up activities required
prior to beginning patient enrollment. However, enrollment of patients in Study
105 remains dependent upon the Company's ability to secure adequate near-term
funding for the study and related operating expenses, of which no assurance
can
be given. In addition, the completion of Study 105 will be dependent upon the
Company’s ability to secure adequate longer-term funding or a collaboration
agreement with a strategic partner, of which no assurance can be
given.
About
OxyADF Tablets
OxyADF
(oxycodone HCl/niacin) Tablets, the Company’s lead product candidate with
Aversion® (abuse deterrent) Technology, are orally administered immediate
release tablets containing oxycodone HCl as an active analgesic ingredient,
a
sub therapeutic amount of niacin and several functional inactive ingredients.
The Company intends to file a 505(b)(2) NDA for OxyADF Tablets with an
anticipated indication for treating moderate to moderately severe pain. OxyADF
Tablets are intended to effectively treat moderate to moderately severe pain
while also discouraging the three most common methods of misuse and abuse
including (i) intravenous injection of dissolved tablets, (ii) nasal snorting
of
crushed tablets and (iii) intentional swallowing of excessive numbers of
tablets. The Company anticipates that OxyADF Tablets will be scheduled as a
C-II
product by the U.S. Drug Enforcement Administration (DEA).
OxyADF
Tablet Commercial Manufacturing Site Qualification Plan
In
addition to agreement for the SPA, the Company has also received written FDA
guidance confirming agreement in all material respects with the Company's
proposed commercial manufacturing site qualification plan. The Company is
currently in discussions with prospective commercial product suppliers and
intends to include relevant data from the selected supplier's commercial
manufacturing site in the NDA submission for OxyADF Tablets. OxyADF Tablets
utilize a dry blend, direct compression manufacturing process. This process
requires commonly utilized blending and tablet compression equipment and,
compared to other tablet product formulations, is simple and
economical.
About
the OxyADF Tablet Market Opportunity
Based
on
market research data purchased by the Company from IMS Health, for the 12 months
ended September 30, 2006, approximately 227 million total prescriptions (brands
and generics combined) were dispensed in the U.S. for immediate release and
extended release tablet and capsule forms of opioid analgesics. Of these
dispensed prescriptions, approximately 13 million were for extended release
products (usually administered every 8 to 24 hours) and 214 million were for
immediate release products (usually administered every 4 to 6 hours). Extended
release products are more commonly prescribed for relief of pain for durations
ranging from a few weeks to several months or longer. Immediate release products
are more commonly prescribed for relief of pain for durations of generally
less
than 30 days. According to data published in The
National Survey on Drug Use and Health Report, Issue 22, 2006,
immediate release opioid containing pain relievers are used non-medically
(including through misuse and abuse) approximately ten-fold more often than
extended release products. The Company’s primary market research (the
Company Market Research)
involving more than 1,000 physicians routinely prescribing opioids, suggests
that OxyADF Tablets will be considered by these physicians for use in both
the
immediate release and extended release market segments. In addition, the Company
Market Research indicates that physicians will switch a certain percentage
of
their prescriptions to OxyADF Tablets from other C-II oxycodone HCl containing
products and also from C-III products like hydrocodone with acetaminophen,
although there can be no assurance that this will be the case.
Cash
Reserves
The
Company estimates that its current cash reserves will fund operations, excluding
any outlays for Study 105, through mid July 2007. To continue operating
thereafter and to initiate patient enrollment in Study 105, the Company must
raise additional financing or enter into appropriate collaboration agreements
with third parties providing for cash payments to the Company. No assurance
can
be given that the Company will be successful in obtaining any such financing
or
in securing collaborative agreements with third parties on acceptable terms,
if
at all, or if secured, that such financing or collaborative agreements will
provide for payments to the Company sufficient to continue funding operations.
In the absence of such financing or third-party collaborative agreements, the
Company will be required to scale back or terminate operations and/or seek
protection under applicable bankruptcy laws.
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
press release contains "forward-looking statements" as defined in the Private
Securities Litigation Reform Act of 1995. These statements are based on current
expectations of future events. If underlying assumptions prove inaccurate or
unknown risks or uncertainties materialize, actual results could vary materially
from the Company’s expectations and projections. The most significant of such
risks and uncertainties include, but are not limited to, the Company’s ability
to secure additional financing to fund continued operations, the Company’s
ability to enter into contractual arrangements with qualified pharmaceutical
partners to license, develop and commercialize the Company’s technology and
product candidates, the Company’s ability to avoid infringement of patents,
trademarks and other proprietary rights or trade secrets of third parties,
and
the Company’s ability to fulfill the FDA’s requirements for approving the
Company’s product candidates for commercial distribution in the United States,
including, without limitation, the adequacy of the results of the clinical
studies completed to date and the results of other clinical studies, to support
FDA approval of the Company’s product candidates, the adequacy of the
development program for the Company’s product candidates, changes in regulatory
requirements, adverse safety findings relating to the Company’s product
candidates, the risk that the FDA may not agree with the Company’s analysis of
its clinical studies and may evaluate the results of these studies by different
methods or conclude that the results of the studies are not statistically
significant, clinically meaningful or that there were human errors in the
conduct of the studies or otherwise, the risk that further studies of the
Company’s product candidates are not positive, and the uncertainties inherent in
scientific research, drug development, clinical trials and the regulatory
approval process. You are encouraged to review other important risk factors
relating to the Company on our web site at www.acurapharm.com under the link,
“Company Risk Factors” and detailed in Company filings with the Securities and
Exchange Commission. The Company is at development stage and may never have
any
products or technologies that generate revenue. Acura Pharmaceuticals, Inc.
assumes no obligation to update any forward-looking statements as a result
of
new information or future events or developments. Acura Pharmaceuticals, Inc.
press releases may be reviewed at www.acurapharm.com.