Acura Pharmaceuticals Launches Next Generation Cold Medicine to Aid
in the Fight Against Meth
Nexafed(R)'s Abuse-Deterrent Technology Disrupts Conversion of
Pseudoephedrine to Dangerous Illegal Drug Methamphetamine Without
Compromising Effective Nasal-Congestion Relief
PALATINE, IL -- (Marketwire) -- 12/10/12 -- 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
"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
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
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 m
ethamphetamine, 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.
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.
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 rel
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.
(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.
Drug Enforcement Administration. Maps of Methamphetamine Lab
(4) The RAND Corporation. The Economic Costs the
Methamphetamine Use in the United States, 2005.2009.
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