Acura Pharmaceuticals, Inc. Submits Investigational New Drug Application

Thu Dec 20, 2012 8:00am EST

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

PALATINE, IL, Dec 20 (Marketwire) -- 
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) today announced that an
Investigational New Drug application ("IND") has been filed with the U.S.
Food and Drug Administration (FDA) to allow clinical testing of Acura's
hydrocodone bitartrate with acetaminophen formulated with Aversion(R)
Technology. Clinical testing can commence under the IND 30 days following
the IND filing unless questions are raised by the FDA. An open IND is
required for Acura to initiate intranasal abuse liability testing in
recreational drug users of the crushed drug product.

    This study is part of a comprehensive development program we intend to
complete in anticipation of submitting a 505(b)(2) NDA for our
hydrocodone/acetaminophen product in the first half of 2014. The plan
also includes:


--  a pharmacokinetic study demonstrating dose proportionality and
    evaluating the food effect;
--  a battery of laboratory studies demonstrating extraction, syringing
    and particle size characteristics;
--  a pharmacokinetic study to establish a bridge to a new contract
    manufacturer; and
--  an assessment of the routes of abuse of hydrocodone products.

    

Acura continues to evaluate possible partnering of our Aversion
development products with alternative strategic partners. 

    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 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. 

    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
Commission.

    

Contact: 
for Acura Investor Relations
investors@acurapharm.com
847-705-7709

for Acura Media Relations
pr@acurapharm.com
847-705-7709 

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