Study AP-ADF-114

Product: Acurox® Tablets
Study: AP-ADF-114 or Study 114
Phase: Phase II
Title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users

Study Objective

To compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release oxycodone HCl tablets in non-dependent recreational opioid users.

Design Summary

Study 114 is a randomized, double-blind, placebo- and active-controlled study designed to assess the relative abuse potential of Acurox Tablets.

A total of 46 healthy adult subjects with a history of recreational opioid abuse successfully completed screening, a naloxone challenge (demonstrating no addiction to opioids), a drug discrimination test (demonstrating the ability to discern drug liking between ingesting oxycodone HCl 40mg and placebo), and the treatment phase. In the treatment phase fasted subjects orally administered, in randomized and cross-over manner: (a) 8 x 5mg Roxicodone® tablets, (b) 8 x 10mg Roxicodone tablets, (c) 8 x 5/30mg Acurox with Niacin Tablets, (d) 8 x 10/30mg Acurox with Niacin Tablets, and (e) placebo. The primary efficacy assessment was the 100-mm bipolar visual analog scale Drug Liking/Disliking Assessment taken over 12 hours post-dosing. Secondary assessments included a Take Drug Again Assessment (TDAA) and a Global Assessment of Overall Drug Liking (both 100mm bipolar VAS).

Results Summary

Topline results indicate statistically significant differences between Acurox with Niacin Tablets (40/240mg and 80/480mg) and the respective equivalent Roxicodone doses (40/0mg and 80/0mg) for the peak liking (Emax) as measured by Like/Dislike scores for 8 hours post-administration (p=0.003 and p<0.0001, respectively). There are statistically significant and clinically meaningful decreases between Acurox with Niacin Tablets and the respective equivalent Roxicodone doses in the Take Drug Again Assessment (at 1, 2, and 8 hours; p<=0.001) and the Global Assessment of Overall Drug Liking (assessed at 12 hours; p<=0.0032). No serious adverse events were reported with the majority of adverse events are consistent with the expected impediment effects of niacin (skin burning sensation, skin warm, and flushing).