Acura Pharmaceuticals Announces Top-Line Results of a Clinical Study Assessing Abuse Liability

Acura Pharmaceuticals Announces Top-Line Results of a Clinical Study Assessing 
Abuse Liability 
PALATINE, IL -- (Marketwired) -- 08/26/13 --  Acura Pharmaceuticals,
Inc. (NASDAQ: ACUR) today announced top-line results from Study
AP-ADF-301 (Study 301), a phase II clinical study in 40 recreational
drug abusers assessing the abuse liability of snorting a crushed
hydrocodone bitartrate with acetaminophen tablet formulated with
Acura's abuse deterrent AVERSION technology (AVERSION H&A). 
The results for AVERSION H&A in Study 301 were consistent in certain
respects with the results of a similar study for another AVERSION
product containing oxycodone hydrochloride, which has been approved
by the US Food and Drug Administration (FDA). Study 301's primary
endpoint indicated AVERSION H&A had slightly lower numeric mean
maximum drug liking (Emax: 72.1) compared to an equivalent dose of a
generic hydrocodone/acetaminophen tablet (Generic H&A: Emax: 75.6)
currently on the market, however these results were not statistically
significant (p > 0.025). 
The secondary endpoints demonstrated the effects of the AVERSION
ingredients on drug snorting. AVERSION H&A's mean minimum liking
(Emin: 40.2) was less than Generic H&A (Emin: 50.4) (the difference
being statistically significant at p=0.0003). The mean minimum drug
liking for AVERSION H&A and the placebo control were 40.2 and 48.8,
respectively (the difference being statistically significant at
p=0.0042). A score below 50 indicates a subject disliked the drug
they were taking at some point during the treatment (a score of 50
means neither like or dislike), and a score greater than 50 indicates
they liked the drug they were taking. 
The mean minimum liking results correlated closely the Overall Drug
Liking score (ODL) and Take Drug Again assessment (TDA). ODL assessed
the subject like or dislike for the drug experience 12 hours after
taking the dose. The ODL for AVERSION H&A (52.7) was lower than
Generic H&A (71.0) (the difference being statistically significant at
p=0.0001) with a score of 50 indicating a neither a like or dislike.
TDA assessed a subject's willingness to take the drug again assessed
12 hours after taking the dose. The TDA for AVERSION H&A (45.1) was
lower than Generic H&A (71.0) (the difference being statistically
significant at p=0.0001) with the AVERSION H&A score below 50
indicating an unwillingness to take the drug again. 
There were no serious adverse events reported for AVERSION H&A. There
was no sequence effect identified in the study but a carryover effect
between the 5 study crossover periods was identified for the Emax
measure but not the Emin measure. This effect is being further
evaluated. 
Acura intends to further evaluate the data from this study and plans
to meet with the FDA to discuss these results. AVERSION H&A tablets
contain a unique composition of inactive ingredients intended to
deter common methods of prescription drug abuse such as snorting.
Given the absence of statistical significance in Study 301s primary
endpoint relating to maximum drug liking, the timeline for submission
of a New Drug Application (NDA) for AVERSION H&A is expected to be
delayed. The revised projected timeline for submission of the NDA for
Aversion H&A will be determined following our meeting with the FDA.
Although we do not expect the need to conduct additional nasal abuse
like/dislike studies for AVERSION H&A, this will not be confirmed
until our meeting with the FDA to discuss the Study 301 results. 
Some of the significant differences observed in Study 301 compared to
the results seen for the AVERSION oxycodone hydrochloride product
study include, but are not limited to: (a) mean maximum drug liking
scores for the active comparator (i.e. Generic H&A) were
significantly lower, (b) the time to mean minimum drug liking for
AVERSION H&A was longer, (c) almost all AVERSION H&A subjects snorted
the entire dose compared to only 48% for AVERSION oxycodone
hydrochloride, and (d) AVERSION oxycodone hydrochloride achieved a
statistically significant reduction in mean maximum drug liking
scores before adjusting for an observed sequence effect.  
The Company will host a conference call to discuss the results on
Tuesday, August 27 at 8:30 a.m. ET. To participate in the live
conference call, please dial 888-539-3696 (U.S. and Canada) five to
ten minutes prior to the start of the call. The participant passcode
is 8585569.  
About Study 301 
Study 301 was a phase II, single-center, randomized, double-blind,
5-period crossover assessment of the abuse liability potential of
snorting crushed AVERSION H&A tablets. Forty subjects with a history
of insufflating opioids were randomized into the treatment phase of
the study after demonstrating they could adequately distinguish
euphoria or "high" (measured as drug liking) between placebo and two
different doses of hydrocodone/APAP (the drug discrimination phase).  
In the blinded treatment phase. fasted subjects snorted a single dose
of five different crushed study drugs every 48 hours, using either
10mg or 20mg of hydrocodone bitartrate based on the lowest dose the
subject could adequately distinguish in the drug discrimination
phase. Study drugs were administered in a randomized crossover
design. The primary study drugs were placebo, Generic H&A, and
AVERSION H&A. Two active control drugs were used to blind the
subjects to the different powder volumes of the primary study drugs
and provide information on the impact of powder volume and the
AVERSION ingredients on drug liking scores. 
Subjects snorted the crushed study drugs using both nostrils over 5
minutes in a design to visually blind the study drugs. The primary
endpoint was the subjects' maximum score (Emax) of their drug
like/dislike on a 101-point visual analog scale (VAS) at various
intervals following administration, with a score of 0 indicating a
strong dislike, 100 a strong like and 50 a neutral response.
Secondary endpoints measured on a 101-point VAS scale included the
minimum score (Emin) of their drug like/dislike, the subjects'
willingness to take drug again, assessment of overall drug
like/dislike, and assessment of drug high. Subjects also responded to
a 6-point Likert scale for nasopharyngeal and facial side effects
associated with the AVERSION technology. Pharmacokinetic blood
samples were also collected and analyzed for each subject. 
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(R) 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 HCl tablets) which incorporates the AVERSION(R)
technology. The Company has a development pipeline of additional
AVERSION 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 technology, a unique polymer matrix that disrupts the
conversion of pseudoephedrine into the dangerous drug,
methamphetamine.  
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 expectations of
the results of Study 301, our expectations relating to AVERSION H&A
or other AVERSION Technology product candidates, our expectations
relating to suitability of the Study 301 results for filing with the
FDA and the absence of need to conduct additional nasal abuse
like/dislike studies for AVERSION H&A, the expected timing of
submission of the NDA for AVERSION H&A to the FDA, our expectations
of the side effects associated with AVERSION H&A or other AVERSION
Technology product candidates, the results of our meeting with the
FDA to discuss the results of Study 301, our ability to file for and
obtain FDA approval of the NDA for AVERSION H&A, our and our
licensee's ability to successfully launch and commercialize our
products and technologies including OXECTA Tablets and NEXAFED
Tablets, the price discounting that may be offered by Pfizer for
OXECTA, 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 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.  
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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