Acura Pharmaceuticals, Inc. Submits Investigational New Drug

Acura Pharmaceuticals, Inc. Submits Investigational New Drug
Application 
Request to Commence Clinical Investigation 
PALATINE, IL -- (Marketwire) -- 12/20/12 --  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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