Acura Pharmaceuticals Reaches Key Milestone With Entrance Into Chain Drug Store
KERR DRUG First Chain Drug Store Customer to Stock Nexafed(R) -- Next
Generation Cold/Allergy Medicine With Abuse-Deterrent Technology --
Joining the Fight Against Meth Abuse
PALATINE, IL -- (Marketwire) -- 03/05/13 -- 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 operate."
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 JOIN-FIGHT.COM.
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 purification.
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.
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 Commission.
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