CONTACT:
Acura Pharmaceuticals, Inc.
Peter A. Clemens, SVP Investor Relations & CFO
(847-705-7709)
FOR IMMEDIATE RELEASE

ACURA PHARMACEUTICALS INC.
ANNOUNCES NOTICE OF ALLOWANCE FOR ISSUANCE OF
PATENT FOR DETERRING ABUSE OF OPIOID CONTAINING DOSAGE FORMS
Palatine, IL, December 11, 2006:
Acura Pharmaceuticals, Inc.
(OTC.BB-ACUR) today
announced receipt from the United States Patent and Trademark Office of
a Notice of Allowance for a non-provisional patent application titled
“Methods and Compositions for Deterring Abuse of Opioid Containing
Dosage Forms”. A U.S. patent relating to this Notice of Allowance will
be granted after the Company pays the required fees. The patent claims
in the Notice of Allowance are directed to pharmaceutical compositions
intended to reduce or discourage the three most common routes of
prescription opioid analgesic product misuse and abuse (the Company's "Aversion®
Technology") including; (i) intravenous injection of dissolved
tablets or capsules; (ii) snorting of crushed tablets or capsules and;
(iii) intentionally swallowing excess quantities of tablets or
capsules. The opioid analgesics in the allowed patent claims include
oxycodone, hydrocodone, hydromorphone, morphine, codeine, tramadol,
propoxyphene and many others. At present, the Company retains ownership
of all intellectual property and commercial rights to its Aversion®
Technology.
Potential Market for Opioid Analgesic Products with Aversion® Technology
According to IMS Health, for the 12 month period ending September 30,
2006, there were more than 225 million dispensed prescriptions in the
U.S. for opioid analgesics. The Company believes that healthcare
providers generally are unable to predict which, if any, of their opioid
analgesic prescriptions will ultimately be abused or diverted to
non-medical use. Based on primary market research conducted by the
Company, physicians in the U.S. believe that nearly one out of six
prescriptions for oxycodone and hydrocodone containing products may be
abused. In addition, the results of a survey published in 2006 of over
1,500 adults conducted by Schulman, Ronca and Bucuvalas, Inc., a market
research firm, revealed that 37% of those surveyed personally know
someone who has abused opioid painkillers. Of those reporting knowing
someone who has abused opioid painkillers, ten percent revealed that
they personally had abused these products and nearly twenty percent of
the abusers were identified as coworkers, with the balance being
identified as family members or acquaintances. The uncertainty about
which, if any, prescriptions for opioid analgesics will be abused or
diverted to non-medical use implies that certain segments of the U.S.
market for opioid analgesic prescriptions may represent an attractive
opportunity for products formulated with the Company's Aversion®
Technology.
OxyADF Tablet Development
OxyADF Tablets, the Company’s lead product
candidate utilizing Aversion® Technology, is an orally administered
immediate release tablet containing oxycodone HCl as its sole active
analgesic ingredient with an anticipated indication for treating acute
moderate to moderately severe pain. OxyADF Tablets are being developed
pursuant to an active investigational new drug application on file with
the United States Food and Drug Administration (“FDA”). To date
the Company, in concert with contract research organizations, has
completed patient enrollment in two phase I clinical trials
(AP-ADF-101and AP-ADF-107), two phase II clinical trials (AP-ADF-102 and
AP-ADF 103), a pivotal bioequivalence trial (AP-ADF-104) and a pivotal
laboratory study assessing the relative difficulty of extracting
oxycodone HCl from OxyADF Tablets for the purposes of illicit
intravenous injection.
The FDA has stated to the Company that
successful completion of additional clinical trials and related study
reports is required prior to the FDA’s acceptance of a 505(b)(2) NDA
submission for OxyADF Tablets. These required activities include; (a)
unblinding of data, analysis and report writing for study AP-ADF-102, a
phase II clinical trial in 24 subjects with a history of opioid abuse;
(b) data analysis and a final report for study AP-ADF-107, a phase I
clinical trial assessing dose response to a certain ingredient in the
OxyADF Tablet composition in 50 healthy normal subjects; (c) successful
completion of study AP-ADF-105, a placebo controlled, pivotal phase III
clinical trial in approximately 400 acute pain patients and; (d) an
additional three or four phase I clinical studies with approximately
25-50 normal subjects per study.
Estimating the dates of initiation and
completion of clinical studies and the costs to complete development of
the Company's product candidates, including OxyADF Tablets, would be
speculative and potentially misleading. The Company expects to reassess
its future research and development plans pending review of data
received from development activities in progress and the availability
of cash resources to fund these activities. The cost and pace of future
research and development activities are linked and subject to change.
At this stage there can be no assurance that any of the Company’s
research and development efforts, including those for OxyADF Tablets,
will lead to a 505(b)(2) NDA submission or that if NDA submissions are
made, that any such submission will be accepted for filing or approved
by the FDA.
About Acura Pharmaceuticals, Inc.
Acura Pharmaceuticals, Inc., together with
its subsidiary, is a specialty pharmaceutical company primarily engaged
in research, development and manufacture of products incorporating
Aversion® Technology.
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 product development and
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.
All Acura
Pharmaceuticals, Inc. press releases may be reviewed at
www.acurapharm.com.

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