Acura Pharmaceuticals Provides Update on Partnership With Pfizer

Acura Pharmaceuticals Provides Update on Partnership With Pfizer 
PALATINE, IL -- (Marketwired) -- 07/01/13 --  Acura Pharmaceuticals,
Inc. (NASDAQ: ACUR), a specialty pharmaceutical company innovating
abuse deterrent drugs, today announced that Pfizer Inc. (NYSE: PFE)
will expand commercialization of OXECTA(R) (oxycodone HCl) Tablets
CII to health care providers in the 4th quarter of 2013. These
activities will be directed to a national cross section of healthcare
professionals who treat pain, but will not include the use of field
"We are pleased Pfizer is advancing the commercialization plan for
OXECTA," said Bob Jones, president and chief executive officer of
Acura Pharmaceuticals. 
Acura has exclusively licensed its AVERSION(R) Technology to Pfizer
in the United States, Canada and Mexico for use in OXECTA. Acura
receives tiered royalties ranging from 5% to 25% on net sales (gross
sales less discounts, if any) of OXECTA. 
OXECTA is indicated for the management of acute and chronic moderate
to severe pain where the use of an opioid analgesic is appropriate.
OXECTA is the first immediate-release oxycodone HCl tablet that
applies AVERSION technology. The U.S. Food and Drug Administration
(FDA) approved OXECTA in June 2011. 
OXECTA Important Safety Information
 OXECTA is contraindicated in
patients with respiratory depression in unmonitored settings and in
the absence of resuscitative equipment, in any patient who has or is
suspected of having paralytic ileus, in patients with acute or severe
bronchial asthma or hypercarbia, and in patients with known
hypersensitivity to oxycodone, oxycodone salts, or any components of
the product. 
Respiratory depression is the primary risk of OXECTA. This is more
common in elderly or debilitated patients, in those suffering from
conditions such as COPD, severe asthma, or upper airway obstruction,
or following large initial doses of opioids given to non-tolerant
OXECTA contains oxycodone HCl, an opioid agonist and a Schedule II
controlled substance. Such drugs are sought by drug abusers and
people with addictions. OXECTA can be abused in a manner similar to
other opioids and narcotics. This should be considered when
prescribing or dispensing oxycodone HCl in situations where the
physician or pharmacist is concerned about an increased risk of
misuse or abuse. OXECTA may be abused by crushing, chewing, snorting
or injecting the product. These practices pose a significant risk to
the abuser that could result in overdose and death. OXECTA should not
be given to anyone other than the individual for whom it was
prescribed. Keep OXECTA in a locked cabinet, drawer or medicine safe
so that it will not be stolen.  
There is no evidence that OXECTA has a reduced abuse liability
compared to immediate-release oxycodone.  
Take each OXECTA tablet with enough water to ensure complete
swallowing immediately after placing in the mouth, and OXECTA must be
swallowed whole. As OXECTA is not amenable to crushing and
dissolution, do not use OXECTA in nasogastric, gastric or other
feeding tubes as it may cause obstruction of feeding tubes. 
Patients who have not been receiving opioid analgesics should start
on OXECTA in a dosing range of 5 to 15 mg every 4 to 6 hours as
needed for pain. The dose should be titrated based upon the
individual patient's response to their first dose of OXECTA. Patients
with chronic pain may need to be dosed at the lowest dosage level
that will achieve acceptable pain relief and tolerable adverse
reactions, on an around-the-clock basis rather than on an as needed
basis. When a patient no longer needs treatment with OXECTA after
long-term use, it is important to gradually taper OXECTA over time to
prevent withdrawal symptoms. 
Patients taking OXECTA in combination with other medicines like
sedatives, anesthetics or narcotics may have serious problems such as
respiratory depression, low blood pressure, profound sedation, or
coma. Do not drink alcoholic beverages or take any medicines
containing alcohol while taking OXECTA. 
Use OXECTA with caution in patients with head injuries or other
conditions that increase pressure in the brain, shock with low blood
volume, severe undiagnosed abdominal conditions, history of seizures,
severe kidney or liver disease, gall bladder disease, Addison's
disease, hypothyroidism, enlarged prostate or other illnesses that
make urination difficult and elderly or debilitated patients. Do not
use OXECTA in patients with intestinal obstruction especially
paralytic ileus. 
Patients taking OXECTA should use caution when driving a car,
operating heavy machinery or doing similar, potentially dangerous
tasks as OXECTA may impair abilities needed to drive or perform
potentially dangerous activities. 
The most common adverse reactions are nausea, constipation, vomiting,
headache, itchiness, trouble sleeping, dizziness, loss of
strength/energy, and sleepiness.  
Keep OXECTA out of the reach of children. If a child accidently takes
OXECTA, seek emergency medical help immediately.  
Full Prescribing Information for OXECTA can be found here 
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. AVERSION contains polymers that cause
the drug to gel when dissolved; it also contains compounds that
irritate the nasal passages. IMPEDE is designed to disrupt the
processing of pseudoephedrine from tablets into methamphetamine. 
In June 2011, the U.S. Food and Drug Administration approved
OXECTA(R) (oxycodone HC1 tablets) which incorporates the AVERSION(R)
technology. The Company has a development pipeline of additional
AVERSION(R) technology products containing 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,
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
forwarding-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 results, performance, or achievements expressed
or implied by such forward-looking statements. Forward-looking
statements may include, but are not limited to, our ability to raise
capital under the shelf registration statement from the sale of our
securities, 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 pr
oducts, the willingness of
wholesalers and pharmacies to stock Nexafed 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," "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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