Acura Pharmaceuticals Reaches Key Milestone With Entrance Into Chain Drug Store Market

Tue Mar 5, 2013 6:00am EST

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  PALATINE, IL, Mar 05 (Marketwire) -- 
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) today announced that its new
next generation pseudoephedrine with abuse deterrent technology will now
be stocked by chain drug store KERR DRUG. Nexafed(R) [pseudoephedrine
hydrochloride (HCl)], is a 30 mg immediate-release pseudoephedrine
product that combines effective nasal-congestion relief with a unique
technology that disrupts the conversion of pseudoephedrine into the
dangerous drug, methamphetamine (meth). Meth production and abuse is a
growing problem in communities nationwide.

    "We are extremely pleased with KERR DRUG's decision to join the fight
against methamphetamine abuse by stocking Nexafed(R)," said Robert B.
Jones, president and chief executive officer of Acura Pharmaceuticals.
"We anticipated early interest in Nexafed(R) from independent pharmacies
but it is rewarding that forward-looking drug chains like KERR DRUG are
stepping up to make a difference in the communities in which they

    With more than 75 locations, KERR DRUG is a North Carolina-based drug
store chain with deep roots in their communities and has historically
been recognized as a pharmacy leader. Nexafed(R) should begin to appear
on KERR DRUG shelves within two weeks.

    Nexafed(R) launched commercially in December 2012 and is now available
through national and regional drug wholesalers. Nexafed(R) delivers the
same efficacy and is priced comparably to name-brand pseudoephedrine
products. For more information about Nexafed(R), please visit

    About Nexafed(R)

    Nexafed(R) [pseudoephedrine hydrochloride (HCl)] is a 30 mg
immediate-release abuse-deterrent decongestant. The next generation
pseudoephedrine tablet combines effective nasal-congestion relief with
Impede(TM) technology, a unique polymer matrix that disrupts the
conversion of pseudoephedrine into the dangerous drug, methamphetamine.
Specifically, the Impede(TM) technology forms a thick gel when the
tablets are dissolved in solvents typically used in the pseudoephedrine
extraction or methamphetamine production processes, trapping the
pseudoephedrine or converted methamphetamine to prevent its isolation or

    About Acura Pharmaceuticals

    Acura Pharmaceuticals is a specialty pharmaceutical company engaged in
the research, development and commercialization of product candidates
intended to address medication abuse and misuse, utilizing its
proprietary AVERSION(R) and IMPEDE(TM) technologies.

    In June 2011, the U.S. Food and Drug Administration approved OXECTA(R)
which incorporates the AVERSION(R) technology. The Company has a
development pipeline of additional AVERSION(R) technology products
including other opioids.

    In December, 2012 the Company commenced commercialization of Nexafed(R)
[pseudoephedrine hydrochloride (HCl)] a 30 mg immediate-release
abuse-deterrent decongestant. 

    The trademark OXECTA(R) is owned by Pfizer Inc.

    Forward-Looking Statements 

    Certain statements in this press release constitute "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors which may cause our actual
results, performance or achievements to be materially different from any
future results, performance, or achievements expressed or implied by such
forward-looking statements. Forward-looking statements may include, but
are not limited to, our and our licensee's ability to successfully launch
and commercialize our products and technologies including Oxecta(R)
Tablets and Nexafed(R) Tablets, the price discounting that may be offered
by Pfizer for Oxecta(R), our and our licensee's ability to obtain
necessary regulatory approvals and commercialize products utilizing our
technologies and the market acceptance of and competitive environment for
any of our products, the willingness of wholesalers and pharmacies to
stock Nexafed(R) Tablets, expectations regarding potential market share
for our products and the timing of first sales, our ability to enter into
additional license agreements for our other product candidates, our
exposure to product liability and other lawsuits in connection with the
commercialization of our products, the increased cost of insurance and
the availability of product liability insurance coverage, the ability to
avoid infringement of patents, trademarks and other proprietary rights of
third parties, and the ability of our patents to protect our products
from generic competition, our ability to protect and enforce our patent
rights in any paragraph IV patent infringement litigation, and the
ability to fulfill the FDA requirements for approving our product
candidates for commercial manufacturing and distribution in the United
States, including, without limitation, the adequacy of the results of the
laboratory and clinical studies completed to date, the results of
laboratory and clinical studies we may complete in the future to support
FDA approval of our product candidates and the sufficiency of our
development to meet over-the-counter, or OTC, Monograph standards as
applicable, the adequacy of the development program for our product
candidates, including whether additional clinical studies will be
required to support FDA approval of our product candidates, changes in
regulatory requirements, adverse safety findings relating to our product
candidates, whether the FDA will agree with our analysis of our clinical
and laboratory studies and how it may evaluate the results of these
studies or whether further studies of our product candidates will be
required to support FDA approval, whether or when we are able to obtain
FDA approval of labeling for our product candidates for the proposed
indications and will be able to promote the features of our abuse
discouraging technologies, whether our product candidates will ultimately
deter abuse in commercial settings and whether our Impede technology will
disrupt the processing of pseudoephedrine into methamphetamine. In some
cases, you can identify forward-looking statements by terms such as
"may," "will," "should," "could," "would," "expects," "plans,"
"anticipates," "believes," "estimates," "projects," "predicts,"
"potential" and similar expressions intended to identify forward-looking
statements. These statements reflect our current views with respect to
future events and are based on assumptions and subject to risks and
uncertainties. Given these uncertainties, you should not place undue
reliance on these forward-looking statements. We discuss many of these
risks in greater detail in our filings with the Securities and Exchange


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