Acura Pharmaceuticals Launches Next Generation Cold Medicine to Aid in the Fight Against Meth

Mon Dec 10, 2012 8:00am EST

* Reuters is not responsible for the content in this press release.

  PALATINE, IL, Dec 10 (Marketwire) -- 
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) today announced the launch of
Nexafed(R) [pseudoephedrine hydrochloride (HCl)], a 30 mg
immediate-release next generation pseudoephedrine product, combining
effective nasal-congestion relief with a unique technology that disrupts
the conversion of pseudoephedrine into the dangerous drug,
methamphetamine. Nexafed(R) is now available to national and regional
drug wholesalers and will be available to pharmacies soon. This is the
second of two products to reach the market that utilize Acura's
abuse-deterrent technologies.

    "The launch of Nexafed(R) is a significant milestone for Acura and in the
continued fight against meth in the U.S.," said Robert B. Jones,
president and chief executive officer of Acura Pharmaceuticals. "Acura is
highly committed to addressing the needs of local communities by
investing in the development of abuse-deterrent technologies and
medicines. It's not about innovating once, but continuing to improve on
the technology without compromising efficacy."

    Nexafed(R) delivers the same efficacy as leading pseudoephedrine
products. In a clinical study Nexafed(R) was shown to meet the Food and
Drug Administration's (FDA) guidelines for bioequivalence when compared
to the leading national brand product.(1) For consumers, confirmation of
bioequivalence provides assurance that Nexafed(R) delivers the same cold
and allergy relief they have come to rely on -- but with the added
benefit of disrupting possible methamphetamine production.

    Pseudoephedrine, a decongestant used in some cold and allergy medicines,
is the primary ingredient converted during illegal methamphetamine
production. Unlike other cold and allergy pseudoephedrine products,
Nexafed(R) is the only medicine that utilizes Acura's Impede(TM)
technology, a unique polymer matrix that disrupts the extraction and
conversion of pseudoephedrine to methamphetamine. If abusers try to
extract the pseudoephedrine out of Nexafed(R) to make methamphetamine,
the inactive ingredients in the polymer matrix will form a thick gel to
block that extraction and disrupt conversion of pseudoephedrine to
methamphetamine. 

    Laboratory tests conducted on Acura's behalf by an independent research
organization demonstrated that in the two methods of methamphetamine
production that require pseudoephedrine extraction prior to conversion,
no pseudoephedrine could be extracted and isolated from Nexafed(R) using
a range of aqueous and organic solvents. In addition, in the direct
conversion method, or "one-pot" technique used in home labs, laboratory
tests demonstrated that Impede(TM) technology reduced the yield of
methamphetamine from conversion of pseudoephedrine by about half of that
derived from the leading national brand product.

    "The introduction of cold and allergy products with abuse-deterrent
technologies is a significant step forward for communities across the
country affected by the debilitating effects of meth production," said
Priscilla Lisicich, executive director of Safe St. located in Tacoma,
Washington and former co-chair of the National Methamphetamine Training
and Technical Assistance Center. "A medicine that deters meth production
without compromising efficacy will ensure people have access to the
medicines that they need."

    Methamphetamine production and abuse is a serious problem that has become
increasingly common in communities across the U.S. In 2011, approximately
439,000 Americans ages 12 years and older had abused methamphetamine.(2)
The impact of methamphetamine extends beyond those who use and abuse the
drug. Methamphetamine production creates increased danger in communities
from fire, explosions, exposure to toxic chemicals and crime.

    Last year, more than 10,000 clandestine labs were found in the U.S.,
triggering environmental hazards and requiring expensive and timely
cleanup by local governments.(3) In addition to environmental hazards,
the economic cost of methamphetamine use in the U.S. -- estimated at
$23.4 billion in 2005 -- is staggering, accounting for the burden of
addiction and drug treatment.(4)

    "We hope the availability of Nexafed(R) empowers pharmacists to impact
meth abuse at a local level by stocking and recommending the product,"
said Jones. In a recent market research study, 70 percent of chain and
independent pharmacists involved in pharmacy stocking decisions said they
were likely to stock or recommend stocking Nexafed(R) in their
pharmacies. These pharmacists further indicated a willingness to
recommend Nexafed(R) to over 50 percent of their customers who seek a
pharmacist's advice in need of a single ingredient nasal decongestant
like Nexafed(R).

    Nexafed(R) is now available to national and regional drug wholesalers and
will be available to pharmacies soon. Acura has priced Nexafed(R)
comparably to name-brand pseudoephedrine products. For more information
about Nexafed(R), please visit JOIN-FIGHT.COM.

    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
purification. 

    About Acura Pharmaceuticals
 Acura Pharmaceuticals, Inc. is a specialty
pharmaceutical company dedicated to bringing safe and effective products
intended to address medication abuse and misuse to market. As a leader in
abuse-deterrent technology, Acura has also successfully developed a
prescription drug product that addresses abuse and which is licensed to
and marketed by a major pharmaceutical company. Acura is committed to
addressing the needs of local communities by investing in ongoing
research and development to drive improvement in drug-deterrent
technology.

    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, the
timing of, our ability to successfully launch and commercialize
Nexafed(R) Tablets, 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, the adequacy of the
results of the laboratory and clinical studies completed to date, the
sufficiency of our development to meet over-the-counter, or OTC,
Monograph standards as applicable, adverse safety findings relating to
our product candidates, our exposure to product liability and other
lawsuits in connection with the commercialization of our products, the
increasing cost of insurance and the availability of product liability
insurance coverage, and whether our Impede(TM) technology, including our
Nexafed(R) Tablets, 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," "indicated," "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.

References
 (1) Data on file; Acura
Pharmaceuticals, Inc., Palatine, IL
 (2) Substance Abuse and Mental
Health Services Administration, Results from the 2011 National Survey on
Drug Use and Health: Summary of National Findings, NSDUH Series H-44, HHS
Publication No. (SMA) 12-4713. Rockville, MD: Substance Abuse and Mental
Health Services Administration, 2012.
 (3) Drug Enforcement
Administration. Maps of Methamphetamine Lab Incidents. 
 (4) The RAND
Corporation. The Economic Costs the Methamphetamine Use in the United
States, 2005.2009. 

    
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Contacts:
Pete Clemens
Acura Pharmaceuticals
pr@acurapharm.com 
(847) 705-7709

Media:
Leticia Diaz
Spectrum
ldiaz@spectrumscience.com
(202) 955-6222 

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