Study AP-ADF-114

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. In Study 114, approximately 47 fasted recreational drug abuse subjects received single oral doses in five test treatments including (a) two potentially abused excess doses of Acurox® (oxycodone/niacin) Tablets, (b) two potentially abused excess oral doses of oxycodone HCl alone, and (c) placebo. Dosing occurred every 48 hours. Prior to the first test treatment, each subject first demonstrated, through naloxone challenge, that they were not dependent on opioids. Also, each subject demonstrated their ability to distinguish, on a 100-point VAS like/dislike scale, between placebo and oxycodone doses randomly administered on a blinded basis. Endpoints assessing abuse potential include subjective assessments on a 100-point VAS of drug liking/disliking, take drug again, and global overall drug liking/disliking.

Results Summary

Study 114 top-line results demonstrate that two different potentially abused excess oral doses of Acurox® Tablets are significantly disliked compared to equivalent excess oral doses of oxycodone HCl tablets alone (without niacin). All five co-primary endpoints comparing the like/dislike of excess doses of Acurox® Tablets with the like/dislike of excess doses of oxycodone HCl tablets alone (without niacin) each achieved statistical significance (p < 0.0001). Study 114 primary endpoint results are supplemented by multiple independently measured secondary endpoints, all of which achieved statistically significant results (p < 0.05). The Study 114 design may be reviewed at www.clinicaltrials.gov (from the clinicaltrials.gov home page click on “Search for Clinical Trials” and then enter “Acurox” in the search box). Acurox® is an investigational new drug product and is not approved for marketing or commercial distribution.