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Acura Pharmaceuticals,
Inc.
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.
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