Acura Reports Absence Of Statistical Significance In Study 301s Primary Endpoint

(RTTNews) - Acura Pharmaceuticals, Inc. (ACUR) on Monday announced top-line results from Study AP-ADF-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 the company's abuse deterrent AVERSION technology.

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.

Study 301's primary endpoint indicated AVERSION H&A had slightly lower numeric mean maximum drug liking compared to an equivalent dose of a generic hydrocodone/acetaminophen tablet currently on the market, but those results were not statistically significant, the company said.

The secondary endpoints demonstrated the effects of the AVERSION ingredients on drug snorting. AVERSION H&A's mean minimum liking was less than Generic H&A. The mean minimum drug liking for AVERSION H&A and the placebo control were 40.2 and 48.8, respectively. A score below 50 indicates a subject disliked the drug they were taking at some point during the treatment, and a score greater than 50 indicates they liked the drug they were taking.

Acura intends to further evaluate the data from the study and plans to meet with the FDA to discuss the results.

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 for AVERSION H&A is expected to be delayed.

Acura said the revised projected timeline for submission of the NDA for Aversion H&A will be determined following its meeting with the FDA.