Study Objective

To evaluate the relative intravenous (IV) abuse liability of Acurox Tablets

Design Summary

In consultation with experts in the field, a laboratory protocol for evaluating the relative IV abuse liability of Acurox Tablets was designed. To provide unbiased, scientifically derived and documented study results, we engaged a laboratory contract research organization (“CRO”) specializing in pharmaceutical product analysis to execute the protocol. The protocol was intended to mimic the uncontrolled "real world" environment, except that professional chemists with access to a wide range of laboratory equipment and supplies would pose as potential IV drug abusers. As would be the case with a potential IV drug abuser, these chemists were allowed unrestricted access to information in developing oxycodone extraction methods and techniques. The CRO was provided with a list of ingredients (active and inactive) contained in each test product, allotted up to 80 hours total time to complete the evaluations and allowed to use any methodology and/or solvents desired to attempt to extract oxycodone HCl from the tablets in a form suitable for I.V. injection. The test products were: OxyContin® (oxycodone HCl) Tablets 1 x 40 mg (Purdue Pharma), Oxycodone HCl Tabs 8 x 5 mg (Mallinckrodt), Percocet® (oxycodone HCl/APAP) Tablets 8 x 5/325 mg (Endo) and -Acurox (oxycodone HCl/niacin) Tablets 8 x 5/30 mg (Acura).

Results Summary

The results of the Extraction Test suggest that currently marketed oxycodone HCl containing tablets may be easily dissolved in water in as little as 3 – 10 minutes for potential abuse via IV injection. By contrast, the Extraction Test simulation suggests that preparing an injectable form of Acurox® Tablets is difficult and not practical due to the time required (almost 6 hours) and the inability to obtain a sufficient oxycodone yield that would provide any degree of euphoric effect to the prospective drug abuser.

Percocet® is a registered trademark of Endo Laboratories, Inc.
OxyContin® is a registered trademark of Purdue Pharma L.P.