Acura Says Results from Top-Line Study Assessing Abuse Liability 'Not Statistically Significant'

Acura Pharmaceuticals,Inc. (NASDAQ: ACUR) today announced top-line results from StudyAP-ADF-301 (Study 301), a phase II clinical study in 40 recreationaldrug abusers assessing the abuse liability of snorting a crushedhydrocodone bitartrate with acetaminophen tablet formulated withAcura's abuse deterrent AVERSION technology (AVERSION H&A).The results for AVERSION H&A in Study 301 were consistent in certainrespects with the results of a similar study for another AVERSIONproduct containing oxycodone hydrochloride, which has been approvedby the US Food and Drug Administration (FDA). Study 301's primaryendpoint indicated AVERSION H&A had slightly lower numeric meanmaximum drug liking (Emax: 72.1) compared to an equivalent dose of ageneric hydrocodone/acetaminophen tablet (Generic H&A: Emax: 75.6)currently on the market, however these results were not statisticallysignificant (p > 0.025).The secondary endpoints demonstrated the effects of the AVERSIONingredients on drug snorting. AVERSION H&A's mean minimum liking(Emin: 40.2) was less than Generic H&A (Emin: 50.4) (the differencebeing statistically significant at p=0.0003). The mean minimum drugliking for AVERSION H&A and the placebo control were 40.2 and 48.8,respectively (the difference being statistically significant atp=0.0042). A score below 50 indicates a subject disliked the drugthey were taking at some point during the treatment (a score of 50means neither like or dislike), and a score greater than 50 indicatesthey liked the drug they were taking.The mean minimum liking results correlated closely the Overall DrugLiking score (ODL) and Take Drug Again assessment (TDA). ODL assessedthe subject like or dislike for the drug experience 12 hours aftertaking the dose. The ODL for AVERSION H&A (52.7) was lower thanGeneric H&A (71.0) (the difference being statistically significant atp=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 assessed12 hours after taking the dose. The TDA for AVERSION H&A (45.1) waslower than Generic H&A (71.0) (the difference being statisticallysignificant at p=0.0001) with the AVERSION H&A score below 50indicating an unwillingness to take the drug again.There were no serious adverse events reported for AVERSION H&A. Therewas no sequence effect identified in the study but a carryover effectbetween the 5 study crossover periods was identified for the Emaxmeasure but not the Emin measure. This effect is being furtherevaluated.Acura intends to further evaluate the data from this study and plansto meet with the FDA to discuss these results. AVERSION H&A tabletscontain a unique composition of inactive ingredients intended todeter common methods of prescription drug abuse such as snorting.Given the absence of statistical significance in Study 301s primaryendpoint relating to maximum drug liking, the timeline for submissionof a New Drug Application (NDA) for AVERSION H&A is expected to bedelayed. The revised projected timeline for submission of the NDA forAversion H&A will be determined following our meeting with the FDA.Although we do not expect the need to conduct additional nasal abuselike/dislike studies for AVERSION H&A, this will not be confirmeduntil our meeting with the FDA to discuss the Study 301 results.Some of the significant differences observed in Study 301 compared tothe results seen for the AVERSION oxycodone hydrochloride productstudy include, but are not limited to: (a) mean maximum drug likingscores for the active comparator (i.e. Generic H&A) weresignificantly lower, (b) the time to mean minimum drug liking forAVERSION H&A was longer, (c) almost all AVERSION H&A subjects snortedthe entire dose compared to only 48% for AVERSION oxycodonehydrochloride, and (d) AVERSION oxycodone hydrochloride achieved astatistically significant reduction in mean maximum drug likingscores before adjusting for an observed sequence effect.The Company will host a conference call to discuss the results onTuesday, August 27 at 8:30 a.m. ET. To participate in the liveconference call, please dial 888-539-3696 (U.S. and Canada) five toten minutes prior to the start of the call. The participant passcodeis 8585569.